GERMAN DRUG LAW

This section is intended to  give you an impression of the content of the German Drug Law, "Arzneimittelgesetz" or "AMG". It reflects the legals situation as of late 2010.

This translation is not official - valid is the German version.

 

MEDICINAL PRODUCTS ACT

(THE DRUG LAW)

(ARZNEIMITTELGESETZ – AMG)

of the

FEDERAL REPUBLIC OF GERMANY

Non-official translation as of 2010

 

This version incorporates:

1. the version of the notification of the Law of 12th December 2005 (Federal Law Gazette I p.

3394),

2. Article 12 of the Law of 14th August 2006 (Federal Law Gazette I p. 1869), which entered

into force on 18th August 2006.

3. Article 5 of the Law of 21st December 2006 (Federal Law Gazette I p. 3294), which entered

into force on 28th December 2006,

4. Article 2 of the Law of 21st December 2006 (Federal Law Gazette I p. 3367), which entered

into force on 29th December 2006,

5. Article 30 of the Law of 26th March 2007 (Federal Law Gazette I p. 378), which partially

entered into force on 1st April 2007 and will partially enter into force on 1st January 2009

6. Article 2 of the Law of 14th June 2007 (Federal Law Gazette I p. 1066), which entered into

force on 30th June 2007,

7. Article 2 of the Law of 20th July 2007 (Federal Law Gazette I p. 1574), which entered into

force on 1st August 2007,

8. Article 2 of the Law of 24th October 2007 (Federal Law Gazette I p. 2510), which entered

into force on 1st November 2007,

9. Article 9 (1) of the Law of 23rd November 2007 (Federal Law Gazette I p. 2631), which

entered into force on 1st January 2008,

10. Article 2 of the Law of 15th July 2009 (Federal Law Gazette I p. 1801), which entered into

force on 21st July 2009,

11. Article 1 of the Law of 17th July 2009 (Federal Law Gazette I p. 1990, p. 3578), which entered

into force on 23rd July 2009,

12. Article 1 of the Ordinance of 28th September 2009 (Federal Law Gazette I p. 3172), which

entered into force on 3rd October 2009.

 

Medicinal Products Act

(The DRUG LAW)

(Arzneimittelgesetz – AMG))

Summary of Contents

First Chapter

Purpose of the Act, definition of terms, scope

§ 1 Purpose of the Act

§ 2 The term ‘medicinal product’

§ 3 The term ‘substance’

§ 4 Definitions of additional terms

§ 4a Exceptions to the scope of the present Act

§ 4b Special provisions governing advanced therapy medicinal products

) This Act serves to incorporate:

 

Second Chapter

Requirements on medicinal products

§ 5 Prohibition in respect of unsafe medicinal products

§ 6 Empowerment in respect of health protection

§ 6a Prohibition of medicinal products for doping purposes in sport

§ 7 Radiopharmaceuticals and medicinal products treated with

ionizing radiation

§ 8 Prohibitions to prevent deception

§ 9 The party responsible for placing on the market

§ 10 Labelling

§ 11 Package leaflet

§ 11a Expert information

§ 12 Empowerment for labelling, package leaflet and pack sizes

Third Chapter

Manufacture of medicinal products

§ 13 Manufacturing authorisation

§ 14 Decision on the manufacturing authorisation

§ 15 Expert knowledge

§ 16 Limitation of the manufacturing authorisation

§ 17 Deadlines for the granting of an authorisation

§ 18 Withdrawal, revocation, suspension

§ 19 Areas of responsibility

§ 20 Obligations to notify

§ 20a Applicability to active substances and other substances

§ 20b Authorisation for the procurement of tissues and the pertinent

laboratory testing

§ 20c Authorisation for the processing, preservation, testing and

storage or the placing on the market of tissues or

preparations made from tissues

§ 20d Exception from the obligation to obtain an authorisation for

tissues and tissue preparations

 

Fourth Chapter

Marketing authorisation for medicinal products

§ 21 Obligation to obtain a marketing authorisation

§ 21a Authorisation of tissue preparations

§ 22 Marketing authorisation documents

§ 23 Particular documents required for medicinal products

intended for administration to animals

§ 24 Expertises

§ 24a Use of a previous applicant's documents

§ 24b Authorisation of a generic medicinal product, document protection

§ 24c Additional requests

§ 24d General right of use

§ 25 Decision on marketing authorisation

§ 25a Prior examination

§ 25b Mutual-recognition procedure and decentralised procedure

§ 25c Measures taken by the competent higher federal authority on

decisions of the European Commission or the Council of the

European Union

§ 26 Guidelines for the testing of medicinal products

§ 27 Deadlines for the granting of marketing authorisations

§ 28 Power to impose conditions

§ 29 Obligation to notify, renewal of the marketing authorisation

§ 30 Withdrawal, revocation, suspension

§ 31 Expiry, prolongation

§ 32 Official batch testing

§ 33 Costs

§ 34 Informing the public

§ 35 Empowerments in respect of marketing authorisation

and exemptions

§ 36 Empowerment in respect of standard marketing authorisations

§ 37 Authorisation by the Commission of the European Communities

or the Council of the European Union for placing on the market,

marketing authorisations for medicinal products from other states

 

Fifth Chapter

Registration of medicinal products

§ 38 Registration of homeopathic medicinal products

§ 39 Decision on the registration of homeopathic medicinal products,

procedural provisions

§ 39a Registration of traditional herbal medicinal products

§ 39b Registration documents for traditional herbal medicinal products

§ 39c Decision on the registration of traditional herbal medicinal products

§ 39d Other procedural provisions for traditional herbal medicinal products

Sixth Chapter

Protection of human subjects in clinical trials

§ 40 General conditions for the clinical trial

§ 41 Special conditions for the clinical trial

§ 42 Ethics committee procedure, procedure for authorisation by the

higher federal authority

§ 42a Withdrawal, revocation and suspension of the authorisation

or of the favourable opinion

Seventh Chapter

Sale of medicinal products

§ 43 Pharmacy-only requirement, placing on the market by

veterinarians

§ 44 Exceptions to the pharmacy-only requirement

§ 45 Authority to allow further exceptions to pharmacy-only

requirement

§ 46 Authority to extend the pharmacy-only requirement

§ 47 Distribution channel

§ 47a Special distribution channels, obligation to keep records

§ 47b Special distribution channels, diamorphine

§ 48 Prescription requirement

§ 49 (deleted)

§ 50 Retail trading of over-the-counter medicinal products

§ 51 Sale by itinerant traders

 

§ 52 Prohibition of self-service

§ 52a Wholesale trading of medicinal products

§ 52b Supply of medicinal products

§ 53 Expert consultation

Eighth Chapter

Safety and quality control

§ 54 Internal regulations

§ 55 Pharmacopoeia

§ 55a Official compilation of test procedures

Ninth Chapter

Special provisions for medicinal products intended for use in animals

§ 56 Medicated feedingstuffs

§ 56a Prescription, dispensing and use of medicinal products by

veterinarians

§ 56b Exceptions

§ 57 Acquisition and possession by keepers of animals, records

§ 58 Use in food-producing animals

§ 59 Clinical trial and residue testing in food-producing animals

§ 59a Trade in substances and preparations from substances

§ 59b Substances for conducting residue tests

§ 59c Obligations to keep records of substances which can be

used as veterinary medicinal products

§ 60 Pet animals

§ 61 Powers of veterinary schools

Tenth Chapter

Observation, collection and evaluation of the risks of medicinal products

§ 62 Organisation

§ 63 Graduated plan

§ 63a Graduated plan officer

§ 63b Documentation and notification obligations

§ 63c Special documentation and notification obligations for blood

 

and tissue preparations

Eleventh Chapter

Supervision

§ 64 Conducting supervision

§ 65 Sampling

§ 66 Obligation to tolerate and collaborate

§ 67 General notification requirement

§ 67a Database-supported information system

§ 68 Obligation to inform and to report

§ 69 Measures by the competent authorities

§ 69a The supervision of substances which can be used as

medicinal products for animals

§ 69b Use of specific data

Twelfth Chapter

Special provisions for the Federal Armed Forces,

Federal Police, Public Order Police, Civil Protection

§ 70 Application and enforcement of the Act

§ 71 Exceptions

Thirteenth Chapter

Import and export

§ 72 Import authorisation

§ 72a Certificates

§ 72b Import authorisation and certificates for tissues and

specific tissue preparations

§ 73 Prohibition of introduction

§ 73a Export

§ 74 Participation of customs offices

 

Fourteenth Chapter

Information Officer, Pharmaceutical Consultant

§ 74a Information Officer

§ 75 Expert knowledge

§ 76 Duties

Fifteenth Chapter

Designation of the competent higher federal authorities and other provisions

§ 77 Competent higher federal authority

§ 77a Independence and transparency

§ 78 Prices

§ 79 Authority to permit exceptions in times of crises

§ 80 Authority to issue procedural and compassionate use regulations

§ 81 Relation to other laws

§ 82 General administrative regulations

§ 83 Approximation to Community legislation

Sixteenth Chapter

Liability for damages caused by medicinal products

§ 84 Absolute liability

§ 84a Right to disclosure

§ 85 Contributory negligence

§ 86 Extent of liability for damages in the case of death

§ 87 Extent of liability for damages in the case of bodily injury

§ 88 Maximum amounts

§ 89 Compensation in the form of annuities

§ 90 (deleted)

§ 91 Extended liability

§ 92 Mandatory provisions

§ 93 Several parties liable for damages

§ 94 Coverage provision

§ 94a Local jurisdiction

 

Seventeenth Chapter

Penal provisions and provisions on administrative fines

§ 95 Penal provisions

§ 96 Penal provisions

§ 97 Administrative fines

§ 98 Confiscation

§ 98a Extended forfeiture

Eighteenth Chapter

Transitional and interim provisions

First sub-chapter

§s 99 to 124 Transitional provisions arising out of the Law on the Reform

of Drug Legislation

Second sub-chapter

§s 125 and 126 Transitional provisions arising out of the First Act

Amending the Drug Law

Third sub-chapter

§s 127 to 131 Transitional provisions arising out of the Second Act

Amending the Drug Law

Fourth sub-chapter

§ 132 Transitional provisions arising out of the Fifth Act

Amending the Drug Law

Fifth sub-chapter

§ 133 Transitional provisions arising of the Seventh Act

Amending the Drug Law

 

Sixth sub-chapter

§ 134 Transitional provisions arising out of the Transfusion Act

Seventh sub-chapter

§ 135 Transitional provisions arising out of the Eighth Act

Amending the Drug Law

Eighth sub-chapter

§ 136 Transitional provisions arising out of the Tenth Act

Amending the Drug Law

Ninth sub-chapter

§ 137 Transitional provisions arising out of the Eleventh Act

Amending the Drug Law

Tenth sub-chapter

§ 138 Transitional provisions arising out of the Twelfth Act

Amending the Drug Law

Eleventh sub-chapter

§ 139 Transitional provisions arising out of the First Act

Amending the Transfusion Act and the Regulations on

Medicinal Products

Twelfth sub-chapter

§ 140 Transitional provisions arising out of the Thirteenth Act

Amending the Drug Law

 

Thirteenth sub-chapter

§ 141 Transitional provisions arising out of the Fourteenth Act

Amending the Drug Law

Fourteenth sub-chapter

§ 142 Transitional provisions arising out of the Tissues Act

Fifteenth sub-chapter

§ 143 Transitional provisions arising out of the Act on improving measures

against doping in sport

Sixteenth sub-chapter

§ 144 Transitional provisions arising out of the Act amending the

regulations on medicinal products and other regulations

Annex

 

FIRST CHAPTER

PURPOSE OF THE ACT, DEFINITION OF TERMS, SCOPE

§ 1

Purpose of the Act

It is the purpose of the present Act to guarantee, in the interest of furnishing both human

beings and animals with a proper supply of medicinal products, safety in respect of the trade in

medicinal products, ensuring in particular the quality, efficacy and safety of medicinal products

in accordance with the following provisions.

§ 2

The term ‘medicinal product’

(1) Medicinal products are substances or preparations made from substances which:

1. are intended for use on or in the human or animal body and are intended for use as

remedies with properties for the curing, alleviating or preventing of human or animal diseases

or disease symptoms or

2. can be used in or on the human or animal body or can be administered to a human being

or an animal, either:

a) to restore, correct or to influence the physiological functions through a pharmacological,

immunological or metabolic effect, or

b) to make a medical diagnosis.

(2) The following shall be considered as medicinal products:

1. objects which contain a medicinal product pursuant to sub-§ 1 or to the surface of

which a medicinal product specified in sub-§ 1 is applied and which are intended to

come into either temporary or permanent contact with the human or animal body,

1a. veterinary instruments in so far as they are intended for single use and the labelling of

which indicates that they have been subjected to a procedure for microbe reduction,

 

2. objects which, without being objects pursuant to number 1 or 1a, are intended for the

purposes indicated in sub-§ 1 number 2 or 5, to be introduced either temporarily or

permanently into the human or animal body, with the exception of veterinary instruments,

3. wound dressings and surgical sutures in so far as they are intended for use on or in animals

and are not covered by numbers 1, 1a or 2,

4. substances and preparations made from substances which, also in combination with

other substances or preparations made from substances, without being applied on or in

the human or animal body, are intended to diagnose the nature, state or functions of the

animal body or to identify pathogens in animals.

(3) The term 'medicinal product' shall not apply to:

1. foodstuffs within the meaning of § 2 sub-§ 2 of the Food and Feed Code,

2. cosmetic products within the meaning of § 2 sub-§ 5 of the Food and Feed

Code,

3. tobacco products within the meaning of § 3 of the Provisional Tobacco Act,

4. substances or preparations made from substances which are exclusively intended for the

external cleaning or hygiene or for influencing the appearance or the body odour of an

animal, provided that no substances or preparations made from substances are added

which are excluded from trade outside of pharmacies,

5. biocidal products pursuant to § 3b of the Act on the Protection against Hazardous

Substances,

6. feedingstuffs within the meaning of § 3 numbers 11 to 15 of the Food and Feed

Code,

7. medical devices and accessories for medical devices within the meaning of § 3 of the

Medical Devices Act unless they are medicinal products within the meaning of § 2

sub-§ 1 number 2,

8. organs within the meaning of § 1a number 1 of the Transplantation Act if they are intended

for transplanting to human beings.

 

(3a) Medicinal products are also products which are or contain substances or preparations

made from substances which, taking into account all the properties of the product, fall under

the definition contained in sub-§ 1 and, at the same time, can fall under the definition

of a 'product' pursuant to sub-§ 3.

(4) As long as a product is authorised or registered as a medicinal product pursuant to

the present Act, or is exempted from the need for authorisation or registration by ordinance,

such product shall be considered as a medicinal product. A product shall not be considered as

a medicinal product if its authorisation or registration has been rejected by the competent

higher federal authority, on the grounds that it is not a medicinal product.

§ 3

The term ‘substance’

For the purpose of the present Act, substances are:

1. chemical elements and chemical compounds as well as their naturally occurring mixtures

and solutions,

2. plants, parts of plants and plant constituents, algae, fungi or lichen whether in the processed

or crude state,

3. the bodies of animals, including those of living animals, as well as parts of the body, body

constituents and metabolic products of human beings or animals, whether in the processed

or crude state,

4. micro-organisms, including viruses, as well as their constituents or metabolic products.

§ 4

Definitions of additional terms

(1) Finished medicinal products are medicinal products which are manufactured beforehand

and placed on the market in packaging intended for distribution to the consumer or other

medicinal products intended for distribution to the consumer, in the preparation of which any

form of industrial process is used or medicinal products which are produced commercially, except

in pharmacies. Finished medicinal products are not intermediate products intended for further

processing by a manufacturer.

 

(2) Blood preparations are medicinal products which are or which contain, as medically

active substances, blood, plasma or serum conserves obtained from blood, blood components

or preparations made from blood components.

(3) Sera are medicinal products within the meaning of § 2 sub-§ 1 which

contain antibodies, fragments of antibodies or fusion proteins with a functional antibody component

as their active substance and are used because of this active substance. Sera shall not

be considered as blood preparations as defined in sub-§ 2 or as tissue preparations as

defined in sub-§ 30.

(4) Vaccines are medicinal products within the meaning of § 2 sub-§ 1, containing

antigens or recombinant nucleic acids and intended for use in human beings or animals

for the production of specific antitoxins and protective agents and, in so far as they contain recombinant

nucleic acids, intended exclusively for the prevention or treatment of infectious diseases.

(5) Allergens are medicinal products within the meaning of § 2 sub-§ 1, containing

antigens or haptens and intended for use on human beings or animals for the diagnosis

of specific antitoxins or protective agents (test allergens) or containing substances which are

used to achieve an antigen-specific reduction in the case of a specific immunological oversensitivity

(therapeutic allergens).

(6) Test sera are medicinal products within the meaning of § 2 sub-§ 2

number 4, which are obtained from blood, organs, parts of organs or secretions from organs of

the healthy or the sick, or from beings who have been sick or previously immunized, which contain

specific antibodies and which are intended to be used on account of these antibodies, as

well as the control sera appertaining to these medicinal products.

(7) Test antigens are medicinal products within the meaning of § 2 sub-§ 2

number 4, which contain antigens or haptens and which are intended to be used as such.

(8) Radiopharmaceuticals are medicinal products which are or contain radioactive substances

and spontaneously emit ionizing radiation and which are intended to be used on account

of these properties; radionuclides (precursors) which have been manufactured for the radiolabelling

of other substances prior to administration as well as systems with a fixed mother

radionuclide which forms a daughter radionuclide (generators) shall also be regarded as radiopharmaceuticals.

 

(9) Advanced therapy medicinal products are gene therapy medicinal products, somatic

cell therapy medicinal products or tissue engineered products pursuant to Article 2, paragraph

1, letter a of Regulation (EC) No. 1394/2007 of the European Parliament and the Council of 13th

November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC

and Regulation (EC) No. 726/2004 (OJ EC No. L 324 of 10th December 2007, p. 121).

(10) Medicated feedingstuffs are medicinal products in the form of ready feedingstuffs,

manufactured from medicated pre-mixes and mixed feed and intended to be placed on the

market for administration to animals.

(11) Medicated pre-mixes are medicinal products intended exclusively for use in the

manufacture of medicated feedingstuffs. They shall be regarded as finished medicinal

products.

(12) The withdrawal period is the period necessary between the last administration of

the veterinary medicinal product in keeping with its intended purpose to animals and the production

of foodstuffs from such animals, in order to protect public health and ensure that such

foodstuffs do not contain residues in quantities in excess of the maximum limits for pharmacologically

active substances laid down in Council Regulation (EEC) No. 2377/90 of 26th June

1990 laying down a Community procedure for the establishment of maximum residue limits of

veterinary medicinal products used in foodstuffs of animal origin (OJ L 224 p. 1).

(13) Side effects are those unintended, harmful reactions which occur when a medicinal

product is administered in keeping with its intended purpose. Serious side effects are side effects

which are fatal or life-threatening, require hospitalisation or the prolongation of existing

hospitalisation, or lead to permanent or serious disability, invalidity, congenital anomalies or

birth defects; in the case of medicinal products intended for administration to animals, side effects

are also serious if they cause recurring or persistent symptoms. Unexpected side effects

are side effects the nature, extent or outcome of which differs from the medicinal product's

package leaflet. Sentences 1 to 3 also apply to such side effects as occur as a result of interactions.

(14) Manufacturing is the producing, preparing, formulating, treating or processing, filling

as well as decanting, packaging, labelling and release of medicinal products.

(15) Quality is the nature of a medicinal product, determined by identity, content, purity

and other chemical, physical and biological properties or by the manufacturing procedure.

 

(16) A batch is the quantity of a medicinal product produced from the same amount of

starting material in a standard manufacturing process or, in the case of a continuous manufacturing

process, within a specific period of time.

(17) Marketing is the keeping in stock for sale or for other forms of supply, the exhibiting

and offering for sale and the distribution to others.

(18) In the case of medicinal products requiring a marketing authorisation or registration,

the pharmaceutical entrepreneur shall be the holder of the marketing authorisation or registration.

The pharmaceutical entrepreneur is also any person who places medicinal products

on the market under his/her own name.

(19) Active substances are substances which are intended for use as medically active

constituents in the manufacture of medicinal products or which, through their use in the manufacture

of medicinal products, are intended to become medically active substances.

(20) (deleted)

(21) Xenogenic medicinal products are medicinal products intended for use in or on humans

which are or contain living animal tissues or cells.

(22) Wholesale trade in medicinal products is any professional or commercial activity for

the purpose of doing business which consists of the procuring, storing, dispensing or exporting

of medicinal products, with the exception of the dispensing of medicinal products to consumers

other than physicians, dentists, veterinarians or hospitals.

(23) A clinical trial on human beings is any investigation on human subjects intended to

investigate or verify the clinical or pharmacological effects of medicinal products, or to identify

side-effects or to study the absorption, distribution, metabolisation or excretion, with the aim of

ascertaining the safety or efficacy of the medicinal product. Sentence 1 does not apply to noninterventional

trials. A non-interventional trial is a study, in the context of which findings resulting

from persons' treatment with medicinal products are analysed using epidemiological methods;

the treatment, including the diagnosis and monitoring, shall not follow a predetermined trial

protocol but shall result exclusively from current medical practice; in so far as a medicinal product

requiring a marketing authorisation or a medicinal product requiring an authorisation pursuant

to § 21a sub-§ 1 is concerned, this shall be conducted, moreover, according to

the specifications regarding its use contained in the marketing authorisation or authorisation.

 

(24) The sponsor is a natural or legal person who assumes responsibility for the commissioning,

organisation and financing of a clinical trial on human beings.

(25) The investigator is generally a physician responsible for the conduct of the clinical

trial on human beings at a site or, in justified exceptional cases, another person whose profession,

owing to the scientific requirements and the experience in the care of patients which it

calls for, qualifies him/her to conduct research on human beings. If a clinical trial is being conducted

by several investigators at one site, the person in charge of the team shall be the principal

investigator. If a clinical trial is being conducted at various trial sites, the sponsor shall name

one investigator as the chief investigator.

(26) A homeopathic medicinal product is any medicinal product prepared in accordance

with a homeopathic manufacturing procedure described in the European Pharmacopoeia or, in

absence thereof, in the pharmacopoeias currently used officially in the EU Member States. A

homeopathic medicinal product can also contain a number of active substances.

(27) A risk linked to the use of a medicinal product is:

a) any risk to patients’ health or public health linked to the quality, safety or efficacy of the

medicinal product and, in the case of medicinal products intended for use in animals, any

risk to human or animal health,

b) any risk of adverse effects on the environment.

(28) The risk-benefit balance is an assessment of the positive therapeutic effects of the

medicinal product in relationship to the risk referred to in sub-§ 27 letter a, and in the

case of medicinal products intended for use in animals, also referred to in sub-§ 27 letter

b.

(29) Herbal medicinal products are medicinal products which exclusively contain, as active

substances, either one or more herbal substances, one or more herbal preparations, or

one or more such herbal substances in combination with one or more such herbal preparations.

(30) Tissue preparations are medicinal products which are tissues within the meaning of

§ 1a number 4 of the Transplantation Act or are manufactured from such tissues. Human

sperm or egg cells including impregnated egg cells (germ cells) and embryos are neither medicinal

products nor tissue preparations.

 

(31) Reconstitution of a finished medicinal product for human use is the conversion of

the medicinal product into its usable form immediately prior to its use according to the specifications

contained in the package leaflet or, within the framework of the clinical trial, in accordance

with the trial protocol.

(32) Introduction is any type of shipment into, through or from the territorial scope of the

present Act. Import is the conveyance of products which fall under the Medicinal Products Act

from third countries which are not States Parties to the Agreement on the European Economic

Area for free circulation.

(33) An anthroposophic medicinal product is a medicinal product which has been developed

according to the anthroposophic understanding of humans and nature, according to a

European Pharmacopoeia or, in the absence thereof, in accordance with a homeopathic manufacturing

practice described in the pharmacopoeias currently used officially in the EU Member

States, or according to a special anthroposophic manufacturing procedure, and which is intended

for use according to the principles of the anthroposophic understanding of humans and

nature.

§ 4a

Exceptions to the scope of the present Act

The present Act shall not apply to:

1. medicinal products which are manufactured using pathogens or biotechnology and are intended

for use in the prevention, diagnosis or cure of epizootics,

2. the procurement and marketing of germ cells for the artificial insemination of animals,

3. tissues which are removed from a person in order to reinsert them without changing their

material structure into the same person in one and the same surgical procedure.

Sentence 1 number 1 shall not apply to § 55.

§ 4b

Special provisions governing advanced therapy medicinal products

(1) In the case of advanced therapy medicinal products which are:

1. prescribed by a doctor as an individual preparation for an individual patient,

 

2. prepared on a non-routine basis according to specific quality standards, and

3. used in a specialised facility for health care under the professional responsibility

of a doctor,

within the scope of the present Act, Parts Four and Seven of the present Act shall not apply.

The remaining provisions of the Act, as well as Article 14 (1) and Article 15 (1-6) of the Regulation

(EC) No. 1394/2007 shall apply mutatis mutandis with the proviso that the official tasks and

powers laid down therein are assumed by the competent authority or the competent higher federal

authority in keeping with the tasks entrusted to them by the present Act and the holder of

the authorisation pursuant to sub-§ 3 sentence 1, takes the place of the marketing authorisation

holder pursuant to the present Act or the marketing authorisation holder pursuant to

Regulation (EC) No. 1394/2007.

(2) Prepared on a non-routine basis pursuant to sub-§ 1 sentence 1 number 2 are,

in particular, medicines:

1. which are manufactured in small quantities, and in the case of which, based on a routine

manufacturing procedure, variations in the procedure which are medically justified for an

individual patient, are carried out, or

2. which have not yet been manufactured in sufficient quantities so that the necessary data

to enable a comprehensive assessment are not yet available.

(3) Medicinal products pursuant to sub-§ 1 sentence 1 may only be supplied to

others if they have been authorised by the competent higher federal authority. § 21a sub§s

2 to 8 shall apply mutatis mutandis. If the necessary information and documents pursuant

to § 21a sub-§ 2 number 6 cannot be submitted, the applicant can submit information

and documents regarding the mode of action, the anticipated effect and possible

risks. The holder of the authorisation shall inform the competent higher federal authority, at

specific intervals stipulated by the competent higher federal authority by means of an ordinance,

about the scale of manufacture and about the data for the comprehensive assessment

of the medicinal product. The authorisation shall be withdrawn if it subsequently becomes

known that one of the prerequisites provided for in sub-§ 1 sentence 1 had not been fulfilled;

it shall be revoked if one of the prerequisites no longer exists. § 22 sub-§ 4

shall apply mutatis mutandis.

 

(4) Enquiries about the obligation to obtain an authorisation for an advanced therapy

medicinal product shall be decided by the competent authority in consultation with the competent

higher federal authority. § 21 sub-§ 4 shall apply mutatis mutandis.

SECOND CHAPTER

REQUIREMENTS ON MEDICINAL PRODUCTS

§ 5

Prohibition in respect of unsafe medicinal products

(1) The placing on the market or the use of unsafe medicinal products on another human

shall be prohibited.

(2) Medicinal products shall be considered unsafe if, according to the current level of

scientific knowledge, there is reason to suspect that, when used in accordance with their intended

purpose, they have harmful effects which exceed the limits considered tolerable in the

light of current medical knowledge.

§ 6

Empowerment in respect of health protection

(1) The Federal Ministry of Health (the Federal Ministry) is hereby empowered to specify,

restrict or prohibit, by ordinance subject to the approval of the Bundesrat, the use of certain

substances, preparations from substances or objects in the manufacture of medicinal products

and to forbid the marketing and use of medicinal products which have not been manufactured

in compliance with these regulations in so far as this is deemed necessary in the interest of risk

prevention or in order to prevent medicinal products from posing a direct or indirect hazard to

human or animal health. The ordinance pursuant to sentence 1 shall be issued by the Federal

Ministry of Consumer Protection, Food and Agriculture in agreement with the Federal Ministry

in so far as the medicinal products are intended for administration to animals.

(2) The ordinance referred to in sub-§ 1 shall be promulgated in agreement with

the Federal Ministry for the Environment, Nature Conservation and Nuclear Safety in the case

of radiopharmaceuticals and medicinal products in the manufacture of which ionizing radiation

is used.

§ 6a

 

Prohibition of medicinal products for doping purposes in sport

(1) The placing on the market, prescribing or administering of medicinal products to others

for the purpose of doping in sport, is prohibited.

(2) Sub-§ 1 shall apply only to medicinal products which contain substances belonging

to the groups of prohibited active substances or substances contained in the Appendix

to the Anti-Doping Convention (Act of 2nd March 1994 on the Anti-Doping Convention of 16th

November 1989, Federal Law Gazette 1994 II p. 334) which are intended for use in the prohibited

measures listed therein in so far as human beings are or are intended to be the subjects of

the doping. The package leaflet and the expert information of these medicinal products shall

contain the following warning: "The use of the medicinal product [insert name of the medicinal

product] can lead to positive results in the event of a doping test." If the misuse of the medicinal

product for doping purposes can endanger health, this shall also be included. Sentence 2 shall

not apply to medicinal products which have been manufactured using a homeopathic manufacturing

procedure.

(2a) The possession of medicinal products and active substances which are or contain

substances listed in the annex to the present Act in non-small quantities for the purpose of doping

in sports is prohibited in so far as human beings are to be the subject of doping. The Federal

Ministry shall specify, in agreement with the Federal Ministry of the Interior, after hearing

experts, by means of ordinance with the approval of the Bundesrat, what constitutes the nonsmall

quantity of the substances mentioned in sentence 1. The Federal Ministry is hereby empowered,

in agreement with the Federal Ministry of the Interior, after hearing experts:

1. to include in the annex to the present Act additional substances which can be used for

doping purposes in sport, are used in considerable quantities for this purpose and the use

of which without a therapeutic assessment is dangerous, and

2. to specify what constitutes a non-small quantity of such substances

by ordinance with the consent of the Bundesrat.

By ordinance pursuant to sentence 3, subtances can be deleted from the annex to the

present Act if the prerequisites contained in sentence 3 number 1 no longer exist.

(3) The Federal Ministry is hereby empowered to specify, in agreement with the Federal

Ministry of the Interior, by ordinance subject to the approval of the Bundesrat, additional sub-

24 -

stances or preparations made from substances to which sub-§ 1 shall apply, in so far as

this is deemed necessary in order to prevent medicinal products from posing a direct or indirect

hazard to human health through doping in sport.

§ 7

Radiopharmaceuticals and medicinal products treated with ionizing radiation

(1) It shall be forbidden for radiopharmaceuticals or medicinal products in the manufacture

of which ionizing radiation has been used to be placed on the market unless the authorisation

to do so has been given by ordinance according to sub-§ 2.

(2) The Federal Ministry is hereby empowered to authorize, in agreement with the Federal

Ministry for the Environment, Nature Conservation and Nuclear Safety, by means of an ordinance

subject to the approval of the Bundesrat, the placing of radiopharmaceuticals on the

market or the use of ionizing radiation in the manufacture of medicinal products in so far as this

is deemed, according to the current level of scientific knowledge, to be justified for medical purposes

and in so far as it does not compromise human or animal health. The ordinance may

prescribe the channel of distribution for the medicinal products and specify that certain data

concerning their radioactivity are to appear on the container, the outer packaging and the

package leaflet. The ordinance shall be issued by the Federal Ministry of Consumer Protection,

Food and Agriculture in agreement with the Federal Ministry and the Federal Ministry for the

Environment, Nature Conservation and Nuclear Safety, in so far as medicinal products intended

for administration to animals are concerned.

§ 8

Prohibitions to prevent deception

(1) It shall be prohibited for medicinal products or active substances:

1. which, by deviating from recognized pharmaceutical principles, are of considerably reduced

quality,

1a. which are incorrectly labelled with regard to their identity or origin (counterfeit medicinal

products, counterfeit active substances) or

2. which bear otherwise misleading names, specifications or presentations to be manufactured

or placed on the market.

 

Deception shall be said to exist, in particular, in cases where

a) claims are made to the effect that certain medicinal products have a therapeutic efficacy

or effects which they do not possess or that active substances exhibit an activity

which they do not,

b) the erroneous impression is given that success can be expected with certainty or

that no harmful effects can be expected to occur when the medicinal product is

used in accordance with its intended purpose or over a prolonged period,

c) names, specifications or presentations having an influence on the assessment of

the medicinal product or active substance are employed to mislead others with regard

to its quality.

(2) It shall be prohibited for medicinal products whose expiry date has elapsed to be

placed on the market.

§ 9

The party responsible for placing on the market

(1) Medicinal products which are placed on the market within the purview of the present

Act shall bear the name or the company and the address of the pharmaceutical entrepreneur.

This shall not apply to medicinal products intended for use in a clinical trial on human subjects.

(2) Within the purview of the present Act, medicinal products may only be placed on the

market by a pharmaceutical entrepreneur whose registered place of business is situated within

the purview of the present Act, in another Member State of the European Union or another

State Party to the Agreement on the European Economic Area. If the pharmaceutical entrepreneur

appoints a local representative, this shall not release him/her from his/her legal responsibility.

§ 10

Labelling

(1) Finished medicinal products which are medicinal products within the meaning of

§ 2 sub-§ 1 or sub-§ 2 number 1, and are not intended for clinical trials on

human beings or exempted from the obligation to obtain a marketing authorisation, pursuant to

§ 21 sub-§ 2 number 1a or 1b, may only be placed on the market within the pur-

26 -

view of the present Act provided that the following information is displayed on the containers

and, where used, on the outer packaging in easily legible and indelible characters, in easily

comprehensible German and pursuant to the details referred to in § 11a:

1. the name or the company and the address of the pharmaceutical entrepreneur and, if

available the name of the appointed local representative,

2. the name of the medicinal product, followed by details of the strength and pharmaceutical

form and, if applicable, information stating that it is intended for administration to babies,

children or adults unless this information is already included in the name,

3. the marketing authorisation number with the abbreviation 'Zul.-Nr.',

4. the batch identification, if the medicinal product is placed on the market in batches, with

the abbreviation 'Ch.-B.'; if it cannot be placed on the market in batches, the date of

manufacture,

5. the pharmaceutical form,

6. the content by weight, volume or number of units,

7. the method of administration,

8. the active substances by type and quantity and other constituents by type in so far as this

is imposed as a condition by the competent higher federal authoritv pursuant to §

28 sub-§ 2 number 1 or provided for by an ordinance pursuant to § 12 sub§

1 number 4, also in conjunction with sub-§ 2, or pursuant to § 36 sub§

1; in the case of medicinal products intended for parenteral or topical use, including

application to the eye, all constituents by type,

8a. in the case of medicinal products produced using genetic engineering, the active substance

and the name of the genetically modified micro-organism or cell line used in its

manufacture,

9. the expiry date with the instruction 'verwendbar bis' (to be used by),

10. in the case of medicinal products which may only be dispensed upon prescription by a

physician, dentist or veterinarian, the indication 'Verschreibungspflichtig' (prescription-

27 -

only), in the case of other medicinal products which may only be dispensed to consumers

in pharmacies, the indication 'Apothekenpflichtig' (pharmacy-only),

11. in the case of samples, the indication 'unverkäufliches Muster' (sample

1. are intended for the exclusive use of members of the medical professions,

2. are placed on the market in containers with a net content of not more than 20 millilitres or

not more than 20 grammes.

(2) Moreover, warnings, specific storage instructions for the consumer as well as storage

instructions for experts shall be given, in so far as this is deemed necessary according to

the current level of scientific knowledge or has been imposed as a condition by the competent

higher federal authority pursuant to § 28 sub-§ 2 number 1 or provided for by an

ordinance.

(3) In respect of sera, information on the type of living organism from which the sera

were obtained, in respect of virus vaccines, information about the host system which was used

for the multiplication of the virus shall be indicated.

(4) In the case of medicinal products included in the Register of Homeopathic Medicinal

Products, instead of the information referred to in sub-§ 1 sentence 1 numbers 1 to 14

and in addition to the clearly recognisable information: 'Homeopathic Medicinal Product”, the

following information shall be included:

1. the nature and quantity of the stocks and the degree of dilution; in this regard, symbols

from the pharmacopoeias currently used officially, should be utilised; the scientific name

of the stock can be supplemented by an invented name,

2. name and address of the pharmaceutical entrepreneur and, if available, of his/her local

representative,

3. method of administration,

4. expiry date; sub-§ 1 sentence 1 number 9 and sub-§ 7 shall apply,

5. pharmaceutical form,

6. content by weight, volume or number of items,

7. information stating that medicinal products should be kept out of the reach of children,

other special precautions for storage and warnings, including additional information for

safe use if required or if stipulated in sub-§ 2,

 

8. batch identification,

9. registration number abbreviated to 'Reg.-Nr.' and the phrase 'Registered homeopathic

medicinal product therefore no therapeutic indication stated',

10. information advising the user to seek medical advice if medical symptoms persist during

the use of the medicinal product,

11. for medicinal products to be dispensed only in pharmacies, the information 'Apothekenpflichtig'

(pharmacy-only),

12. for samples, the information 'Unverkäufliches Muster' (sample

proprietary name recommended by WHO or, in the absence thereof, the common name

unless the name already contains the information on the active substance,

2. the active substance by nature and quantity and other constituents by nature, if this is

stipulated by conditions imposed by the competent higher federal authority pursuant to

§ 28 sub-§ 2 number 1, or stipulated by an ordinance pursuant to § 12

sub-§ 1 number 4, also in conjunction with sub-§ 2 or pursuant to § 36

sub-§ 1,

3. the batch identification,

4. the marketing authorisation number,

5. the name or the company and the address of the pharmaceutical entrepreneur and, if

available, the name of the local representative appointed by him,

6. the animal species for which the medicinal product is intended,

7. the method of administration,

8. the withdrawal, if the medicinal products are intended for administration to food-producing

animals,

9. the expiry date pursuant to sub-§ 7,

10. if necessary, special precautions for the disposal of unused medicinal products,

11. the indication that the medicinal products are to be kept out of the reach of children, additional

special precautions for storage and warnings, including additional information if required

for safe use or if stipulated in sub-§ 2,

12. the indication 'Für Tiere' (for animals),

13. the pharmaceutical form,

14. the content by weight, volume or number of units,

 

15. in the case of medicinal products which may only be dispensed upon veterinary prescription,

the indication 'Verschreibungspflichtig' (prescription-only), in the case of other medicinal

products which may only be dispensed to customers in pharmacies, the indication

'Apothekenpflichtig' (pharmacy-only),

16. in the case of samples, the indication 'Unverkäufliches Muster' (sample – not for sale).

Medicinal products intended for administration to animals, which have been entered into

the Register for Homeopathic Medicinal Products, shall be clearly and visibly labelled

'Homöopathisches Arzneimittel' (homeopathic medicinal product); instead of the information

pursuant to sentence 1 numbers 2 and 4, the information pursuant to sub-§ 4 sentence 1

numbers 1, 9 and 10 shall be provided. Sentences 1 and 2 shall apply mutatis mutandis to medicinal

products which are exempted from registration pursuant to § 28 sub-§ 1

sentence 3 or pursuant to § 60 sub-§ 1. In the case of traditional herbal medicinal

products for administration to animals, the registration number with the abbreviation 'Reg.-Nr.',

instead of the information pursuant to sentence 1 number 4; furthermore, the indications pursuant

to sub-§ 4a sentence 1 number 1 and, corresponding to the administration to animals,

pursuant to number 2, shall be given. The information pursuant to sentence 1 numbers 13 and

14 only need to be given on the outer packaging where an outer packaging exists.

(6) For the designation of the constituents, the following shall apply:

1. for the designation of the type, the World Health Organization's international nonproprietary

names or, if such names do not exist, other common scientific names shall be

used. The Federal Institute for Drugs and Medical Devices shall stipulate, in agreement

with the Paul Ehrlich Institute and the Federal Agency for Consumer Protection and Food

Safety, the names to be used and shall publish these in a database pursuant to §

67a;

2. for the designation of quantity, units of measure shall be used; if biological units or other

specifications regarding valence are customarily in scientific use, then these shall be

used.

(7) The month and the year shall be given as the expiry date.

(8) Blister packaging is to be affixed with the name or the firm of the pharmaceutical entrepreneur,

the name of the medicinal product, the batch identification and the expiry date. It

shall not be necessary to state the name and firm of a parallel importer. In the case of contain-

32 -

ers with a nominal filling quantity of not more than ten millilitres and single-dose ampoules, the

information specified in sub-§s 1, 1a, 2 and 5 need only be displayed on the outer packaging;

the containers and the ampoules must, however, at least bear the information specified

in sub-§ 1 sentence 1 numbers 2, 4, 6, 7, 9 as well as pursuant to sub-§s 3 and 5

sentence 1 numbers 1, 3, 7, 9, 12 and 14; adequate abbreviations may be used. Sentence 3

shall also apply to small containers other than those mentioned therein in so far as divergent

requirements are placed on small containers in procedures pursuant to § 25b.

(8a) In the case of fresh plasma preparations and preparations of blood cells, at least

the information specified in sub-§ 1 sentence 1 numbers 1 and 2 must be included, without

stating the strength, pharmaceutical form and target group, numbers 3, 4, 6, 7 and 9 as well

as the name and volume of the anticoagulant and, if available, the additive solution, storage

temperature, blood group and, in the case of allogenic preparations derived from red blood

cells, the rhesus formula as well and, in the case of thrombocyte concentrates and autologous

preparations from red blood cells, also the rhesus factor. In the case of autologous blood

preparations, the information 'Nur zur Eigenbluttransfusion' (Only for Autologous Blood Donation)

must be given as well and, in the case of autologous and directed blood preparations, also

an indication of the recipient.

(8b) In the case of tissue preparations, at least the information pursuant to sub-§ 1

sentence 1 numbers 1 and 2 without the information regarding the strength, the pharmaceutical

form and target group, number 3 or the authorisation number with the abbreviation 'Gen.-Nr.'

(authorisation number), numbers 4, 6 and 9 as well as the information 'Biologische Gefahr'

(Biological Danger) in the event that infectiosity has been detected must be given. In the case

of autologous tissue preparations, the information 'Nur zur autologen Anwendung' (Only for

Autologous Use) must also be provided and, in the case of autologous and targeted tissue

preparations, an additional indication as to the recipient.

(9) Abbreviations customary in the medicinal product trade may be used in the indications

given in compliance with sub-§s 1 to 5. The company to be indicated under sub§

1 number 1 may be abbreviated, provided that the firm is generally recognizable from

the abbreviation.

(10) For medicinal products which are intended for administration to animals and for use

in a clinical trial or for residue testing, sub-§ 5 sentence 1 numbers 1, 3, 5, 7, 8, 13 and

14 as well as sub-§s 8 and 9 shall be applicable, in so far as they are relevant. Where

relevant, these medicinal products shall be labelled 'Zur klinischen Prüfung bestimmt' (for clini-

33 -

cal trial) or 'Zur Rückstandsprüfung bestimmt' (for residue testing). Blister packaging shall bear

the name, the batch identification and the information pursuant to sentence 2.

(11) Partial amounts removed from finished medicinal products, intended for use in humans,

may only be dispensed with labelling which corresponds at least to the requirements

stipulated in sub-§ 8 sentence 1. Sub-§ 1b shall not apply.

§ 11

Package leaflet

(1) Finished medicinal products which are medicinal products within the meaning of

§ 2 sub-§ 1 or sub-§ 2 number 1 and are intended neither for clinical trial nor

residue testing, or are exempted from the obligation to obtain a marketing authorisation pursuant

to § 21 sub-§ 2 numbers 1a and 1b, may only be placed on the market within

the purview of the present Act with a package leaflet bearing the heading 'Gebrauchsinformation'

(Instructions for Use) and containing, in the same order as below, in easily legible, readily

comprehensible German and in conformity with the information referred to in § 11a:

1. for the purpose of identifying the medicinal product:

a) the name of the medicinal product, § 10 sub-§ 1 sentence 1 number 2

and sub-§ 1a shall apply mutatis mutandis,

b) the substance or indication group or the mode of action,

2. the therapeutic indications,

3. a list of information that must be read before taking the medicinal product:

a) contra-indications,

b) corresponding precautions for use,

c) interactions with other medicinal products or other products, if they are able to influence

the effect of the medicinal product,

d) warnings, especially if imposed by the competent higher federal authority pursuant

to § 28 sub-§ 2 number 2 or stipulated by ordinance pursuant to §

12 sub-§ 1 number 3,

4. the instructions under normal conditions of use, relating to:

 

a) posology,

b) method of administration,

c) frequency of administration, if necessary stating the exact time when the medicinal

product can or must be taken

and, if required, depending on the nature of the medicinal product:

d) duration of treatment if a specific duration is required,

e) warnings in the event of an overdose, forgotten doses or warnings on the risk of

adverse consequences if the treatment is stopped,

f) the specific recommendation that a doctor or pharmacist should be consulted in the

event of queries relating to the use,

5. side effects; if required according to the current state of scientific knowledge, the necessary

countermeasures should be stated; the instruction to the patient that he/she should

inform the physician or pharmacist of any side effect that is not referred to in the package

leaflet,

6. mention of the expiry date stated on the packaging and also:

a) a warning that the medicinal product may not be used after expiry of this date,

b) if required, special precautions for storage and information on shelf life after opening

of the container or after preparation of the ready-to-use preparation by the user,

c) if required, a warning about specific visible signs indicating that the medicinal product

may no longer be used,

d) complete qualitative composition in terms of active substances and other constituents

and quantitative composition in terms of the active substances, using the usual

common names for each of the medicinal product's pharmaceutical forms; §

10 sub-§ 6 shall apply,

e) pharmaceutical form and content by weight, volume or number of items for each of

the medicinal product's pharmaceutical forms,

f) name and address of the pharmaceutical entrepreneur and, where applicable, of

his/her local representative,

g) name and address of the manufacturer or importer who released the finished medicinal

product for placing on the market,

7. in the case of a medicinal product known by other names in other Member States of the

European Union and approved for placing on the market pursuant to Articles 28 to 39 of

 

Directive 2001/83/EC of the European Parliament and of the Council of 6th November

2001 on the Community code relating to medicinal products for human use ( OJ L 311 p.

67), amended by Directives 2004/27/EC (OJ L 136 p. 34) and 2004/24/EC of 31st

March 2004 (OJ L 136 p. 85), a list of the names approved in the individual Member

States,

8. the date of the last revision of the package leaflet.

Explanatory information on the terms listed in sentence 1 is admissible. In so far as information

referred to in sentence 1 is also rendered on the package leaflet in another language,

the information provided in this language shall be identical. Sentence 1 shall not apply to medicinal

products which do not require a marketing authorisation pursuant to § 21 sub§

2 number 1. Additional information, which is not stipulated by a regulation of the European

Community or is already permissible pursuant to such a regulation, is permitted provided

it relates to the use of the medicinal product, is important for the health education of patients

and is not inconsistent with the information referred to in § 11a. With regard to the information

referred to in sentence 1 number 3 letters a to d, account is to be taken of the special

situation of specific groups of persons such as children, pregnant women or nursing mothers,

the elderly or persons with specific diseases, in so far as this is deemed necessary in the light

of the current level of scientific knowledge; furthermore, where necessary, the effects which the

use of the medicinal product could have on a person’s ability to drive or to operate specific machines

should also be indicated.

(1a) A sample of the package leaflet and modified versions shall be sent to the competent

higher federal authority unless the medicinal product is exempted from the obligation to obtain

a marketing authorisation or registration.

(2) Furthermore, the package leaflet shall contain references to constituents, the knowledge

of which is necessary for the safe and effective use of the medicinal product, as well as

specific storage instructions for the consumer in so far as this is deemed necessary according

to the current level of scientific knowledge or if imposed as a condition by the competent higher

federal authority pursuant to § 28 sub-§ 2 number 2, or provided for by ordinance.

(2a) In the case of radiopharmaceuticals, sub-§ 1 shall apply mutatis mutandis

with the proviso that the precautions which are to be taken by the user and the patient in the

preparation and administration of the medicinal product, as well as special precautions for the

disposal of the containers used for transport and for the disposal of medicinal products which

are not used, are taken.

 

(3) In the case of medicinal products included in the register of homeopathic medicinal

products, sub-§ 1 shall apply mutatis mutandis with the proviso that the information stipulated

in § 10 sub-§ 4, with the exception of the batch identification, the expiry date

and the indication stipulated for samples, are included, as well as the name and address of the

manufacturer who released the finished medicinal product for placing on the market, where this

person is not the pharmaceutical entrepreneur. Sentence 1 shall apply mutatis mutandis to medicinal

products which are exempted from registration pursuant to § 38 sub-§ 1

sentence 3.

(3a) In the case of sera, sub-§ 1 shall apply mutatis mutandis with the proviso that

the type of living organism from which they are derived, in the case of virus vaccines, the host

system used for virus multiplication and, in the case of medicinal products derived from human

blood plasma for fractionation, the country of origin of the blood plasma should be stated.

(3b) In the case of traditional herbal medicinal products pursuant to § 39a, sub§

1 shall apply mutatis mutandis with the proviso that the information referred to in sub§

1 sentence 1 number 2, shall state that the medicinal product is a traditional medicinal

product, registered for the specific therapeutic indication, exclusively on the basis of longstanding

use. In addition, the package leaflet should include the advice referred to in §

10 sub-§ 4a sentence 1 number 2.

(3c) The marketing authorisation holder shall ensure that at the request of patients’ organisations,

the package leaflet is made available in formats appropriate for the blind and partially-

sighted persons in the case of medicinal products intended for administration to humans.

(3d) In the case of spa-waters, notwithstanding the requirements referred to in sub§

2, the information referred to in sub-§ 1 sentence 1 number 3 letter b number 4

letters e and f number 5, provided that the information stated therein is stipulated, and number

6 letter c, can be omitted. Furthermore, in the case of spa-waters, the order stipulated in sub§

1 is not compulsory.

(4) In the case of medicinal products which are intended for administration to animals,

sub-§ 1 shall apply accordingly provided that, instead of the information referred to in

sub-§ 1 sentence 1, the following information specified in sub-§ 1 sentences 2 and

3 is given in the same order as below, in clearly legible, readily comprehensible German and in

conformity with the information referred to in § 11a:

 

1. the name and address of the pharmaceutical entrepreneur and, where applicable, of

his/her local representative, and the manufacturer who released the finished medicinal

product for placing on the market,

2. name of the medicinal product, followed by details of the strength and pharmaceutical

form; the common name of the active substance shall be included if the medicinal product

contains only one active substance and its name is an invented name; in the case of a

medicinal product that has been granted marketing authorisation under Articles 31 to 43

of Directive 2001/82 EC of the European Parliament and of the Council of 6th November

2001 on the Community code relating to veterinary medicinal products (OJ L 311 p.1),

amended by Directive 2004/28/EC (OJ L 136 p. 58), under different names in Member

States of the European Union, a list of the names authorised in each Member State,

3. therapeutic indications,

4. contra-indications and side-effects provided that this information is relevant for use;

should it not be possible to provide information in this respect, the indication 'keine

bekannt' (none known) shall be given; the instruction that the user or animal keeper is to

inform the veterinarian or pharmacist of any side-effect that is not listed in the package

leaflet,

5. the animal species for which the medicinal product is intended, dosage instructions for

each species, method and route of administration, if necessary, instructions for use in

keeping with its intended purpose,

6. the withdrawal period, if the medicinal products are intended for administration to foodproducing

animals; should a withdrawal period not be necessary, this shall be indicated,

7. special precautions relating to storage,

8. special warnings in so far as this is imposed as a condition by the competent higher federal

authority or provided for by an ordinance,

9. if necessary due to the current state of scientific knowledge, special precautions for the

disposal of unused medicinal products or other special precautions to avoid risks to the

environment.

 

The date of the last revision of the package leaflet shall be stated. In respect of medicated

pre-mixes, indications for the correct manufacture of medicated feedingstuffs and information

on the shelf life of the medicated feedingstuffs shall be included. Additional information

is permitted in so far as it relates to the use of the medicinal product, is important for the user or

animal keeper and is not inconsistent with the information referred to in § 11a. In the

case of medicinal products for use in animals, which are included in the Register of Homeopathic

Medicinal Products or which are exempted from the registration pursuant to § 38

sub-§ 1 sentence 3 or pursuant to § 60 sub-§ 1 sentences 1, 2 and 4 shall

apply mutatis mutandis subject to the proviso that the information stipulated in § 10 sub§

4, with the exception of the batch identification, the expiry date and the indication stipulated

for samples must be provided. In the case of traditional herbal medicinal products for use

in animals, a corresponding indication pointing to the use in animals pursuant to § 10

sub-§ 4a sentence 1 number 2 shall be given in addition to the indications pursuant to

sub-§ 3b sentence 1.

(5) Should it not be possible to provide the information stipulated in sub-§ 1 sentence

1 number 3 letters a and c as well as number 5, the indication "keine bekannt" (none

known) shall be given. Should additional information be given on the package leaflet, it shall be

clearly set out and well separated from the information specified in sub-§s 1 to 4.

(6) The package leaflet may be omitted provided that the information specified in sub§s

1 to 4 is to be found either on the container or on the outer packaging. Sub-§ 5

shall apply mutatis mutandis.

(7) Partial amounts removed from finished medicinal products, intended for use in humans,

may only be dispensed together with a copy of the package leaflet prescribed for the finished

medicinal product. Sub-§ 6 sentence 1 shall apply mutatis mutandis. By way of

derogation from sentence 1, in the case of the regular dispensing of partial amounts removed

from finished medicinal products and dispensed in new, customised patient blisters in the context

of long-term medication, copies of the package leaflet prescribed for the specific finished

medicinal product must only be inserted if they have been modified compared with those previously

inserted.

§ 11a

Expert information

(1) The pharmaceutical entrepreneur shall be obliged to make available upon request

to physicians, dentists, veterinarians, pharmacists and, if the medicinal products concerned are

 

not subject to prescription, to other persons practising medicine or dentistry professionally, instructions

for use by experts (expert information) for finished medicinal products which are subject

to or exempted from the obligation to obtain a marketing authorisation, are medicinal products

within the meaning of § 2 sub-§ 1 or sub-§ 2 number 1 and are not released

for trade outside of pharmacies. These instructions for expert use shall bear the heading

"Fachinformation" (expert information) and include the following information written in clearly

legible type in conformity with the Summary of Product Characteristics approved within the

framework of the marketing authorisation, and in the following order:

1. the name of the medicinal product followed by the strength and the pharmaceutical form;

2. information on the qualitative and quantitative composition in terms of active substance

and other constituents, knowledge of which is required for proper administration of the

product, with the usual common or chemical name indicated; § 10 sub-§ 6

shall apply;

3. pharmaceutical form;

4. clinical information:

a) therapeutic indications,

b) posology and method of administration for adults and, in so far the medicinal product

is indicated for administration to children, for children,

c) contra-indications,

d) special warnings and precautions for use, and in the case of immunological medicinal

products, any special precautions to be taken by persons coming into contact

with and administering these medicinal products to patients, together with any precautions

to be taken by the patient, if required as a result of conditions imposed by

the competent higher federal authority pursuant to § 28 sub-§ 2 number

1 letter a or if stipulated by an ordinance,

e) interaction with other medicinal products or other products if this is likely to influence

the effect of the medicinal product,

f) use during pregnancy and lactation,

g) effects on ability to drive or operate machinery,

h) side-effects,

i) overdosage: symptoms, emergency procedures, antidotes;

5. pharmacological properties:

 

a) pharmacodynamic properties,

b) pharmacokinetic properties,

c) preclinical safety data;

6. pharmaceutical information:

a) list of other constituents,

b) main incompatibilities,

c) shelf life and where necessary, the shelf life after reconstitution of the medicinal

product or after first opening the container,

d) special precautions for storage,

e) nature and contents of the container,

f) special precautions for disposal of an opened medicinal product, or waste materials

derived from it, in order to avoid any risk to the environment,

7. marketing authorisation holder,

8. marketing authorisation number;

9. the date of first authorisation or prolongation of the authorisation,

10. date of revision of the expert information.

Additional information which is not stipulated by a regulation of the European Community

or is already permissible pursuant to such a regulation shall be permitted if it relates to the

use of the medicinal product and is not inconsistent with the information referred to in sentence

2; such information must be clearly separate and distinct from the information referred to in

sentence 2. Sentence 1 shall not apply to medicinal products, which do not require a marketing

authorisation pursuant to § 21 sub-§ 2 or are manufactured according homeopathic

procedures.

(1a) In the case of sera, the type of living organism from which they are derived, in the

case of virus vaccines, the host system used for virus multiplication and, in the case of medicinal

products derived from human blood plasma for fractionation, the country of origin of the

blood plasma shall be indicated.

(1b) In respect of radiopharmaceuticals, details of the internal radiation dosimetry, additional

detailed instructions for the extemporaneous preparation and the quality control of this

 

preparation shall also be given and, where necessary, the maximum storage time shall also be

indicated during which an intermediate preparation, such as an eluate or the medicinal product

when ready for use, corresponds to its specifications.

(1c) In the case of medicinal products intended for use in animals, the expert information

specified under number 4 'klinische Angaben' (clinical information) must include the following

information:

a) information on each target animal species to which the medicinal product is to be

administered,

b) instructions for use, specifying the target animal species,

c) contra-indications,

d) special warnings for each target animal species,

e) special precautions for use, including special precautions to be taken by the person

administering the medicinal product,

f) side-effects (frequency and seriousness),

g) use during pregnancy, lactation or lay,

h) interactions with other medicinal products and other forms of interaction,

i) dosage and method of administration,

j) overdosage, emergency procedures, symptoms, antidotes, if necessary,

k) withdrawal periods for all foodstuffs, including those for which there is no withdrawal

period.

The information referred to in sub-§ 1 sentence 2 number 5 letter c is not necessary.

(1d) In the case of medicinal products available only on prescription by a doctor, dentist

or veterinarian, the information 'Verschreibungspflichtig' (prescription only) should also be

added, for narcotics the information 'Betäubungsmittel' (narcotics), in the case of other medicinal

products available to consumers only in pharmacies, the information 'Apotheken-pflichtig'

(pharmacy only); in the case of medicinal products containing a substance or a preparation

pursuant to § 48 sub-§ 1 sentence 1 number 3 corresponding information shall be

given.

(1e) For marketing authorisations of medicinal products pursuant to § 24b, the information

referred to in sub-§ 1 relating to therapeutic indications, dosages or other objects

of a patent can be omitted if it is still covered by patent law at the time of placing on the

market.

 

(2) The pharmaceutical entrepreneur shall be obliged to make all modifications to the

expert information, which are relevant for therapy, accessible to the experts in an appropriate

form. In so far as necessary, the competent higher federal authority may, by imposition of a

condition, stipulate the form in which the changes are to be made accessible to all or to certain

groups of experts.

(3) A sample of the expert information and revised versions thereof shall be sent immediately

to the competent higher federal authority unless the medicinal product is exempted from

the obligation to obtain a marketing authorisation.

(4) The obligations referred to in sub-§ 1 sentence 1 can also be fulfilled in the

case of medicinal products which are administered exclusively by members of the health professions

by including the information referred to in sub-§ 1 sentence 2 in the package

leaflet. The package leaflet must be headed with the title "Gebrauchsinformation und Fachinformation"

(instructions for use and expert information).

§ 12

Empowerment in respect of labelling, package leaflet and package sizes

(1) The Federal Ministry is hereby empowered, in agreement with the Federal Ministry

of Economics and Technology by ordinance subject to the approval of the Bundesrat:

1. to extend the provisions of §s 10 and 11a to cover other medicinal products and to

extend the expert information to include further details,

2. to stipulate that the information indicated in §s 10 and 11 are to be made known to

the consumer in another way,

3. to stipulate that, for certain medicinal products or certain groups of medicinal products,

warnings, warning symbols or recognition marks shall be contained in or affixed to:

a) the containers, the outer packaging or the package leaflet or

b) the expert information,

4. to stipulate that specific constituents are to be listed by nature on the containers and

outer packaging or that attention should be drawn to them in the package leaflet,

 

if this is deemed necessary in order to ensure the proper handling and proper administration of

medicinal products within the purview of the present Act and in order to prevent any direct or

indirect risk to human or animal health, which could occur as a result of inadequate information.

(1a) Furthermore, the Federal Ministry is hereby empowered to allow, by ordinance subject

to the approval of the Bundesrat, the use of summarizing names for substances or preparations

from substances in the information provided on containers and outer packaging or in

package leaflets or in expert information, as long as active constituents are not involved and no

direct or indirect hazard to human or animal health arising from a lack of information is to be

feared.

(1b) Furthermore, the Federal Ministry is hereby empowered, in agreement with the

Federal Ministry of Economics and Technology, by means of an ordinance subject to the approval

of the Bundesrat to regulate:

1. the labelling of starting materials intended for the manufacture of medicinal products, and

2. the labelling of medicinal products intended for clinical trials,

where it is deemed necessary to prevent a direct or indirect hazard to human or animal health

owing to inadequate labelling.

(2) In the case of medicinal products intended for administration to animals, the Federal

Ministry of Agriculture, Food and Consumer Protection shall take the place of the Federal Ministry

in the cases provided for in sub-§ 1, 1a, 1b or 3, and shall in each case issue the ordinance

in agreement with the Federal Ministry. The ordinance pursuant to sub-§ 1, 1a or

1b shall be issued in agreement with the Federal Ministry for the Environment, Nature Conservation

and Nuclear Safety in the case of radiopharmaceuticals and medicinal products in the

manufacture of which ionizing radiation is used or where, in the cases provided for in sub§

1 number 3, warnings, warning symbols or recognition marks with regard to the information

stipulated in § 10 sub-§ 1 sentence 1 number 13 or sub-§ 5 sentence

1 number 10, § 11 sub-§ 4 sentence 1 number 9 or § 11a, sub-§ 1

sentence 2 number 6 letter f are required.

(3) Furthermore, the Federal Ministry is hereby empowered to stipulate, by ordinance

not subject to the approval of the Bundesrat, that medicinal products may only be placed on the

market in specific package sizes and that they shall be labelled accordingly by the pharmaceutical

entrepreneur on the container or, if used, on the outer packaging. The fixing of these

 

package sizes shall be done for specific active substances and shall take into account the

therapeutic indications, the duration of application and the pharmaceutical form. In fixing the

package size, the following sub-division shall, in principle, be used as a basis:

1. packages for a short duration of application or tolerance tests,

2. packages for an intermediate duration of application,

3. packages for a relatively prolonged duration of application.

THIRD CHAPTER

MANUFACTURE OF MEDICINAL PRODUCTS

§ 13

Manufacturing authorisation

(1) Any person who manufactures:

1. medicinal products within the meaning of § 2 sub-§ 1 or sub-§ 2 number

1,

2. test sera, test antigens,

3. active substances, which are of human, animal or microbial origin or are manufactured

using genetic engineering, or

4. other substances of human origin intended for the manufacture of medicinal products

on a commercial or professional basis shall require an authorisation by the competent authority.

The same shall also apply to legal persons, non-incorporated associations and companies

established under civil law which manufacture medicinal products for distribution to their members.

Sentence 1 shall apply mutatis mutandis to a trial on the basis of which the release of the

medicinal product is explained. This shall be without prejudice to § 14 sub-§ 4.

(1a) Sub-§ 1 shall not apply to:

1. tissues within the meaning of § 1a number 4 of the Transplantation Act which require

an authorisation pursuant to § 20b or 20c,

 

2. the procurement and the laboratory tests of autologous blood for the manufacture of biotechnologically

processed tissue products which require an authorisation pursuant to §

20b,

3. tissue preparations which require an authorisation pursuant to § 20c,

4. reconstruction, in so far as medicinal products which are intended for use in clinical trials

are concerned.

(2) The following shall not require an authorisation pursuant to sub-§ 1:

1. the owner of a pharmacy manufacturing medicinal products within the scope of the normal

operation of a pharmacy, reconstituting or packaging including the labelling of medicinal

products intended for clinical trials in so far as this corresponds to the trial protocol,

2. the body responsible for a hospital, in so far as it is authorised to distribute medicinal

products pursuant to the Law on Pharmacies, reconstituting or packaging including the

labelling of medicinal products intended for clinical trials in so far as this corresponds to

the trial protocol,

3. the veterinarian operating a veterinary house dispensary for:

a) the decanting, packaging or labelling of medicinal products, without altering them,

b) the manufacture of medicinal products which contain substances or preparations

from substances released exclusively for trade outside of pharmacies,

c) the manufacture of homeopathic medicinal products which, in so far as they are intended

for administration to food-producing animals, contain only active substances

listed in Annex II of Regulation (EEC) No. 2377/90,

d) the preparation of medicinal products from a finished medicinal product and medically

non-active constituents,

e) the mixing of finished medicinal products for the immobilisation of zoo, wild and reserve

animals,

in so far as these activities are undertaken for the animals in his/her care,

 

4. the wholesaler decanting, packaging or labelling medicinal products without altering

them, provided the packages concerned are not intended for direct distribution to the

consumer,

5. the retailer who, in possession of the expert knowledge defined in § 50, decants,

packages or labels medicinal products without altering them for direct distribution to the

consumer,

6. the manufacturer of active substances which are intended for use in the manufacture of

medicinal products which are manufactured using a procedure described in the homeopathic

§ of the Pharmacopoeia.

The exceptions specified in sentence 1 shall not apply to the manufacture of blood

preparations, tissue preparations, sera, vaccines, allergens, test sera, test antigens and radiopharmaceuticals.

(2a) (deleted)

(2b) Furthermore, an authorisation pursuant to sub-§ 1 shall not be required by a

person who is a physician or otherwise authorised to practise medicine on humans in so far as

the medicinal products are manufactured directly under his/her professional responsibility for

personal use by a specific patient. Sentence 1 shall not apply to:

1. advanced therapy medicinal products and xenogenic medicinal products, in so far as

these are or contain living somatic cells which have been genetically modified or whose

biological properties have been changed using other procedures, as well as

2. medicinal products intended for clinical trials in so far as it is not merely a case of reconstitution.

(2c) Sub-§ 2b sentence 1 shall apply mutatis mutandis to veterinarians maintaining

a veterinary house dispensary for use in animals treated by them.

(3) An authorisation issued pursuant to sub-§ 1 concerning the decanting of liquefied

medicinal gases into the delivery receptacle of a tanker truck also covers the decanting of

liquefied medicinal gases, without altering them, from a delivery receptacle of a tanker truck

into containers installed at a hospital or on the premises of other consumers.

 

(4) The decision on the granting of the authorisation shall be reached by the competent

authority of the federal Land where the factory site is situated or is to be situated. As far as

blood products, tissue preparations, sera, vaccines, allergens, advanced therapy medicinal

products, xenogenic medicinal products, medicinal products manufactured using genetic engineering

as well as active substances and other substances intended for the manufacture of

medicinal products and which are of human, animal or microbial origin or are manufactured using

genetic engineering are concerned, the decision on the authorisation shall be reached in

consultation with the competent higher federal authority.

§ 14

Decision on the manufacturing authorisation

(1) An authorisation may only be refused if:

1. there is not at least one person available with the expertise required pursuant to §

15 (qualified person pursuant to § 14) who is responsible for the activity referred

to in § 19,

2. (deleted),

3. the qualified person pursuant to number 1 or the applicant is not sufficiently reliable in the

performance of his/her job,

4. the qualified person referred to in number 1 cannot consistently perform the duties incumbent

upon him,

5. (deleted),

5a. in enterprises which manufacture medicated feedingstuffs from medicated pre-mixes, the

person responsible for supervising the technical side of the manufacturing procedure

does not possess sufficient knowledge and experience in the field of mixing technology,

or

5b. the physician under whose responsibility pre-treatment of the donor is carried out for the

purpose of separating blood stem cells or other blood components, does not possess the

expert knowledge required,

5c. contrary to § 4 sentence 1 number 2 of the Transfusion Act, no physician in charge

has been appointed or said person does not possess the necessary professional knowl-

48 -

edge according to the state of the medical art or, contrary to § 4 sentence 1 number

3 of the Transfusion Act, no physician is present when the withdrawal procedure is

carried out on a human donor,

6. suitable premises and equipment for the intended manufacture, testing and storage of the

medicinal products are not available, or

6a. the manufacturer is not in a position to ensure that the manufacture or the testing of the

medicinal products is carried out according to the latest standards prevailing in science

and technology, and in the procurement of blood and blood components, additionally, according

to the provisions contained in Part Two of the Transfusion Act.

(2) (deleted)

(2a) The physician in charge pursuant to § 4 sentence 1 number 2 of the Transfusion

Act can also be the qualified person pursuant to sub-§ 1 number1.

(2b) (deleted)

(3) (deleted)

(4) By way of derogation from sub-§ 1 number 6, it shall be possible to conduct

partly outside of the manufacturer's factory site:

1. the manufacture of medicinal products for clinical trials on human beings at a commissioned

pharmacy,

2. the changing of the expiry date of medicinal products for clinical trials on human beings at

a trial site by a person commissioned by the manufacturer, in so far as these medicinal

products are exclusively intended for use at this trial site,

3. the testing of medicinal products at commissioned enterprises,

4. the procurement or testing, including laboratory testing of the donor samples of substances

of human origin intended for the manufacture of medicinal products, with the exception

of tissues, in other enterprises or facilities,

 

which require no authorisation of their own, can be carried out on condition that they have the

premises and equipment suitable for this purpose and it is guaranteed that the manufacture

and testing are carried out in accordance with the obtaining state of scientific and technical

knowledge and the qualified person pursuant to number 1 is able to assume his/her responsibilities.

(5) Should the documentation presented be deemed flawed, the applicant shall be given

the opportunity to correct the flaws within an appropriate period of time. If the flaws are not corrected,

the manufacturing authorisation shall be refused.

§ 15

Expert knowledge

(1) Proof of the required expert knowledge on the part of the qualified person referred to

in § 14 shall be furnished by:

1. the licence to practise as a pharmacist, or

2. the diploma in pharmacy, chemistry, biology, human or veterinary medicine attained upon

completion of university studies

as well as a period of at least two years' practical experience in the field of the qualitative and

quantitative analysis and other quality testing of medicinal products.

(2) In the cases specified in sub-§ 1 number 2, proof shall be furnished to the

competent authority that the university studies comprised theoretical and practical instruction at

least in the following basic subjects and that an adequate knowledge exists thereof:

experimental physics,

general and inorganic chemistry,

organic chemistry,

analytical chemistry,

pharmaceutical chemistry,

biochemistry,

physiology,

microbiology,

pharmacology,

pharmaceutical technology,

 

toxicology,

pharmaceutical biology.

The theoretical and practical instruction and sufficient knowledge may also be acquired

at a university upon completion of university studies within the meaning of sub-§ 1 number

2 and may be proved by examination.

(3) Sub-§ 2 shall not apply to the manufacture and testing of blood preparations,

sera, vaccines, allergens, test sera and test antigens. In place of the evidence of practical experience

required in sub-§ 1, proof shall be furnished of at least three years' experience

in the field of medical serology or medical microbiology. By way of derogation from sentence 2,

in place of the practical experience required in sub-§ 1, proof shall be furnished of:

1. at least three years' experience in manufacture or testing in plasma processing enterprises

with a manufacturing authorisation, in addition to at least six months' experience in

the field of transfusion medicine or medical microbiology, virology, hygiene or analytic

procedure, in the case of blood preparations produced from blood plasma for the purpose

of fractionation,

2. at least two years' experience in the field of transfusion medicine covering all the areas of

manufacture and testing in the case of blood preparations made from blood cells and

preparations made from fresh plasma as well as in the case of substances and blood

components for the manufacture of blood preparations,

3. at least six months' experience in transfusion medicine or one year's experience in the

manufacture of autologous blood preparations in the case of autologous blood preparations,

4. in the case of preparations made from blood stem cells, in addition to sufficient knowledge,

at least two year's experience in this field of activity especially in the technology on

which it is based.

With regard to the pre-treatment of patients for the purpose of separating blood stem

cells or other blood components, the responsible physician shall provide evidence of sufficient

knowledge in addition to at least two years' experience in this field of activity. The prerequisites

contained in sub-§ 1 remain valid for packaging and labelling.

 

(3a) Sub-§ 2 shall not apply to the manufacturing and testing of advanced therapy

medicinal products, xenogenic medicinal products, tissue preparations, medicinal products for

use in in-vivo diagnosis by means of marker genes, tissue preparations, radiopharmaceuticals

and active substances. In place of the practical experience required in sub-§ 1, proof

must be furnished of:

1. in the case of gene therapy medicinal products and medicinal products for use in in-vivo

diagnosis by means of marker genes, at least two years' experience in a medically relevant

field, in particular of genetic engineering, microbiology, cell biology, virology or molecular

biology,

2. in the case of somatic cell therapy medicinal products and biotechnologically processed

tissue products, at least two years' experience in a medically relevant field, in particular of

genetic engineering, microbiology, cell biology, virology or molecular biology,

3. in the case of xenogenic medicinal products, at least three years' experience in a medically

relevant field including at least two years' activity particularly in one of the fields

mentioned under number 1,

4. in the case of tissue preparations, at least two years' experience in the manufacture and

testing of such medicinal products in enterprises and facilities which require a manufacturing

authorisation pursuant to the present Act or possess a manufacturing authorisation

under community legislation,

5. in the case of radiopharmaceuticals, at least three years' experience in the field of nuclear

medicine or that of radiopharmaceutical chemistry, and

6. in the case of active substances other than those listed under sub-§ 3 sentence 3

number 2, at least two years' experience in the manufacture and testing of active substances.

(4) The period of practical experience specified in sub-§ 1 shall be spent at a firm

which has been granted a manufacturing authorisation by a Member State of the European Union,

by another State Party to the Agreement on the European Economic Area or by a state

with which an agreement exists as to the mutual recognition of certificates pursuant to §

72a sentence 1 number 1.

 

(5) The period of practical experience shall not be required for the manufacturing of

medicated feedingstuffs from medicated pre-mixes; sub-§ 2 shall not apply.

§ 16

Limitation of the manufacturing authorisation

The authorisation shall be issued to the applicant for a specific factory site and for particular

medicinal products and pharmaceutical forms of medicinal products and, in cases as defined

in § 14 sub-§ 4, also for a specific factory site of the commissioned company

or the other company. In so far as the authorisation includes the testing of medicinal products

or active substances, the type of testing is to be specified.

§ 17

Deadlines for the granting of an authorisation

(1) The competent authority shall reach a decision on the application for an authorisation

within three months.

(2) If the holder of the authorisation makes an application for the authorisation to be

modified in respect of the medicinal products to be manufactured or the premises and equipment

as defined in § 14 sub-§ 1 number 6, the authority shall reach a decision

within one month. In exceptional cases, the deadline shall be extended by a further two

months. The applicant shall be notified thereof prior to the expiry of the deadline and shall be

informed of the grounds.

(3) If the authority gives the applicant the opportunity to correct the flaws pursuant to

§ 14 sub-§ 5, the deadlines shall be interrupted until such flaws have been corrected

or until the expiry of the deadline set pursuant to § 14 sub-§ 5. The interruption

of the deadline shall begin on the day the applicant receives the request to correct the

flaws.

§ 18

Withdrawal, revocation, suspension

(1) The authorisation shall be withdrawn if it becomes known subsequently that one of

the grounds for refusal, pursuant to § 14 sub-§ 1, existed at the time the authorisation

was granted. The authorisation shall be revoked if one of the grounds for refusal subse-

53 -

quently developed; the suspension of the authorisation may be ordered instead of its revocation.

§ 13 sub-§ 4 shall apply mutatis mutandis.

(2) The competent authority may issue a provisional order mandating that the manufacture

of a medicinal product be discontinued if the manufacturer fails to furnish the evidence required

for manufacture and testing. The provisional order may be restricted to one batch.

§ 19

Areas of responsibility

(1) The qualified person pursuant to § 14 shall be responsible for ensuring that

each batch of the medicinal product is manufactured and tested in accordance with the regulations

applicable to the trade in medicinal products. He/she must certify the fulfilment of these

provisions for each batch of medicinal products in a serially numbered register or comparable

document before it is placed on the market.

§ 20

Obligations to notify

The marketing authorisation holder shall notify the competent authority in advance of

any change in the information referred to in § 14 sub-§ 1 and submit evidence. Any

unforeseen change in the qualified person referred to in § 14, must be notified immediately.

§ 20a

Applicability to active substances and other substances

§ 13 sub-§s 2 and 4 and §s 14 to 20 shall apply mutatis mutandis to

active substances and to other substances of human origin intended for use in the manufacture

of medicinal products, in so far as their manufacture or testing pursuant to § 13 sub§

1 requires an authorisation.

§ 20b

Authorisation for the procurement of tissues and the pertinent laboratory testing

 

(1) Any establishment seeking to procure tissues intended for human applications within

the meaning of § 1a number 4 of the Transplantation Act (removal establishments) or

seeking to conduct the laboratory testing necessary for such procurement, shall require an authorisation

from the competent authority. Procurement within the meaning of sentence 1 is the

direct or extracorporeal removal of tissues including all measures which are intended to maintain

the tissues in a processable state, clearly identifiable and transportable. The authorisation

may only be refused if:

1. an appropriately qualified person with the necessary professional experience who, in the

case of a removal establishment, can also be the medical person within the meaning of

§ 8d, sub-§ 1, sentence 1 of the Transplantation Act is not present,

2. the additional personnel involved is insufficiently qualified,

3. appropriate rooms for the specific tissue procurement or for the laboratory testing are not

available, or

4. it is not guaranteed that the procurement of tissues or the laboratory testing are conducted

according to the state of medical science and technology and according to the

provisions contained in Parts 2, 3 and 3a of the Transplantation Act.

The competent authority may dispense with an inspection within the meaning of §

64 sub-§ 3 sentence 2, prior to the granting of an authorisation pursuant to this provision.

The authorisation will be granted to the removal establishment by the competent authority for a

specific facility and for a specific tissue and, to the laboratory, for a specific site and for specific

activities. In the process, the competent authority may involve the competent higher federal authority.

(2) An individual authorisation pursuant to sub-§ 1 shall not be required by a person

conducting such activities on a contractual basis for a manufacturer or a processor who is

in possession of an authorisation pursuant to § 13 or § 20c for the processing of

tissue or tissue preparations. In this case, the manufacturer or processor shall notify the locally

competent authority responsible for the removal establishment or the laboratory of the latter

and shall include, with the notification, the information and documents pursuant to sub-§

1 sentence 3. One month subsequent to the notification pursuant to sentence 2, the manufacturer

or processor shall notify the competent authority responsible for him/her of the removal

establishment or the laboratory unless the competent authority responsible for the removal es-

55 -

tablishment or the laboratory has objected. In exceptional cases, the deadline pursuant to sentence

3 can be extended for an additional two months. The manufacturer or processor shall be

informed thereof before expiry of the deadline and shall be informed of the grounds. If the competent

authority has objected, the deadlines pursuant to sentences 3 and 4 shall be suspended

until the grounds for the objection have been rectified. Sub-§ 1 sentences 3 to 6 shall apply

mutatis mutandis provided that the authorisation pursuant to sub-§ 1 sentence 5 is

granted to the manufacturer or processor.

(3) The authorisation shall be withdrawn if it subsequently becomes known that one of

the grounds for the rejection pursuant to sub-§ 1 sentence 3 existed at the time of the

granting of the authorisation. If one of these grounds arises subsequently, the authorisation

shall be revoked; instead of the revocation, the suspension of the authorisation can also be ordered.

The competent authority is entitled to prohibit the procurement of tissue or the laboratory

testing temporarily if the removal establishment, the laboratory, the manufacturer or the processor

fail to submit the necessary supporting documents for the procurement of tissue or the

laboratory testing.

(4) Sub-§s 1 to 3 shall apply mutatis mutandis for the procurement and the laboratory

testing of autologous blood for the manufacture of biotechnologically processed tissue

products.

§ 20c

Authorisation for the processing, preservation, testing and storage

or the placing on the market of tissues or preparations made from tissues

(1) Any establishment which wishes to process, preserve, test, store or place on the

market tissues or tissue preparations which are not processed using industrial procedures and

the essential processing procedures of which are sufficiently well known in the European Union,

requires, by way of derogation from § 13 sub-§ 1, an authorisation from the

competent authority pursuant to the following provisions. This shall also apply to tissues or tissue

preparations the processing procedures for which are new but comparable with a known

procedure. The decision about whether to grant the authorisation shall be taken by the compe-

56 -

tent authority of the Land in which the facility is located or is to be located, in consultation with

the competent higher federal authority.

(2) The authorisation may only be refused if:

1. a person with the necessary expert knowledge and experience pursuant to sub-§ 3

(responsible person pursuant to § 20c) responsible for ensuring that the tissue

preparations and tissues are processed, preserved, tested, stored or placed on the market

in keeping with the statutory provisions in force, is not available,

2. additional participating personnel is insufficiently qualified,

3. suitable premises and establishments are not available for the envisaged activities,

4. it is not guaranteed that the processing including the labelling, preservation and storage is

conducted according to state-of-the-art scientific and technical procedures, or

5. a quality management system pursuant to the principles of Good Practice has not been

installed or has not been kept up to date.

By way of derogation from sentence 1 number 3, the testing of the tissues and tissue preparations

may be conducted outside of the factory site, in commissioned factories which do not require

an authorisation of their own, if suitable rooms and facilities are available there and if it is

guaranteed that testing is conducted in keeping with the state of the art in science and technology

and the responsible person pursuant to § 20c is able to assume his/her responsibilities.

(3) Proof that the responsible person pursuant to § 20c possesses the necessary

expert knowledge, shall be provided by a certificate testifying to the successful completion of

university studies in human medicine, biology, biochemistry or a course of studies considered

equivalent as well as at least two years' practical experience in the processing of tissues or tissue

preparations.

(4) Should there be any objections against the submitted documents, the applicant shall

be given an opportunity to correct the flaws within an appropriate period of time. If the flaws are

not corrected, the authorisation shall be refused. The authorisation shall be granted for a specific

facility and for specific tissues or tissue preparations.

 

(5) The competent authority shall take the decision on the application for an authorisation

within three months. Should the holder of an authorisation apply for a modification to the

authorisation, the authority shall take the decision within one month. In exceptional cases, the

deadline shall be extended by an additional two months. The applicant shall be notified thereof

prior to the expiry of the deadline and informed of the grounds. If the authority gives the applicant

pursuant to sub-§ 4 sentence 1, the opportunity to correct the flaws, the deadlines

shall be interrupted until such flaws have been corrected or until the expiry of the deadline set

pursuant to sub-§ 4 sentence 1. The interruption of the deadline shall begin on the day

the applicant receives the request to correct the flaws.

(6) The holder of an authorisation shall notify the competent authority in advance of any

change in the information referred to in sub-§ 2 and shall submit evidence thereof; the

changes may be made only after receipt of a written authorisation from the competent authority.

Any unforeseen change in the responsible person pursuant to § 20c shall be notified immediately.

(7) The authorisation shall be withdrawn if it becomes known subsequently that one of

the grounds for refusal, pursuant to sub-§ 2 existed at the time the authorisation was

granted. The authorisation shall be revoked if one of the grounds for refusal developed subsequently,

the suspension of the authorisation may be ordered instead of its revocation. Sub§

1 sentence 3 shall apply mutatis mutandis. The competent authority may issue a provisional

order mandating that the processing of tissues or tissue preparations be discontinued if

the processor fails to furnish the evidence required for processing. If the processing of tissues

or tissue preparations is terminated, the processor shall ensure that stored tissue preparations

and tissues continue to be stored in a quality-assured manner and are transferred to other

manufacturers, processors or distributors in possession of an authorisation pursuant to sub§

1 or § 13 sub-§ 1. This shall also apply to the information and data about

the processing which is necessary for the tracing of these tissue preparations and tissues.

§ 20d

Exception from the obligation to obtain an authorisation

for tissues and tissue preparations

An authorisation pursuant to § 20b sub-§ 1 and § 20c sub-§ 1

shall not be required by a person who is a physician or otherwise authorised to practise medicine

on humans and who performs the activities mentioned therein, with the exception of the

placing on the market, in order to use the tissue or tissue preparation personally on their patient.

This shall not apply to medicinal products which are intended for clinical trials.

 

FOURTH CHAPTER

MARKETING AUTHORISATION FOR MEDICINAL PRODUCTS

§ 21

Obligation to obtain a marketing authorisation

(1) Finished medicinal products which are medicinal products as defined in § 2

sub-§ 1 or sub-§ 2 number 1, may only be placed on the market within the purview

of the present Act, if they have been authorised by the competent higher federal authority or if

the Commission of the European Communities or the Council of the European Union has

granted an authorisation for them to be placed on the market pursuant to Article 3 paragraph 1

or 2 of Regulation (EC) No. 726/2004 of the European Parliament and of the Council of 31st

March 2004 laying down Community procedures for the authorisation and supervision of medicinal

products for human and veterinary use and establishing a European Medicines Agency

(OJ EC No. L 136, p. 1), also in conjunction with Regulation (EC) No. 1901/2006 of the European

Parliament and of the Council of 12th December 2006 on medicinal products for paediatric

use and amending Regulation (EEC) No. 1768/92, Directive 2001/20/EC, Directive 2001/83/EC

and Regulation (EC) No. 726/2004 (OJ L 378 of 27th December 2006, p.1) or Regulation (EC)

No. 1394/2007. The same shall apply to medicinal products which are not finished medicinal

products and which are intended for administration to animals, provided they are not intended

for distribution to pharmaceutical entrepreneurs holding an authorisation for the manufacture of

medicinal products.

(2) A marketing authorisation (Zulassung) shall not be required for medicinal products

which:

1. are intended for administration to human beings and the essential manufacturing stages

of which, owing to the documented frequency with which they are the subject of medical

and dental prescriptions, are carried out in a pharmacy in an amount of up to one hundred

packages ready for dispensing in the space of one day within the framework of the

existing pharmacy operating licence,

1a. are medicinal products manufactured from substances of human origin, which are either

intended for autologous use or for targeted administration to a specific person, or are

prepared on prescription for individual persons, unless medicinal products pursuant to

§ 4 sub-§ 4 are concerned,

 

1b. are medicinal products other than those referred to in number 1a, which are manufactured

for pharmacies which are in possession of a prescription for a patient from medicinal

products authorised within the purview of the present Act

a) as cytostatic preparations or for parenteral nutrition, as well as in other medically

justified cases of special need if it is necessary in order to provide adequate care for

the patient and no other medicinal product with a marketing authorisation is available,

or

b) as a blister from unchanged medicinal products, or

c) are decanted in an unchanged form,

1c. are intended for use in human beings, show antibacterial or antiviral efficacy and are intended

for the treatment of a dangerous communicable disease – the spread of which

renders necessary an immediate supply of specific medicinal products in excess of normal

requirements – and are manufactured from active substances, which have been

stored for this purpose by Federal and Land health authorities, or agencies designated by

them, provided that they are manufactured in a pharmacy for dispensing within the

framework of the existing pharmacy operating licence of for dispensing to other pharmacies,

1d. are tissue preparations which are subject to the obligation to obtain a marketing authorisation

pursuant to the provisions contained in § 21a sub-§ 1,

1e. are curative waters, moor muds for baths or other peloids, which are not manufactured in

advance and are not intended to be placed on the market in a specific packaging for sale

to the consumer, or which are intended exclusively for external use or for inhalation on

the premises,

1f. are medicinal gases and are manufactured for individual persons from medicinal products

authorised within the purview of the present Act through filling and labelling in enterprises

authorised pursuant to § 50 to conduct retail trade in medicinal products outside of

pharmacies,

1g. are therapeutic allergens manufactured to order for individual patients,

2. are intended for use in clinical trials on human beings,

 

3. are medicated feedingstuffs, manufactured in keeping with their designated purpose from

medicated pre-mixes for which a marketing authorisation has been issued pursuant to

§ 25,

4. are manufactured for individual animals or animals belonging to a specific stock, in pharmacies

or in veterinary house dispensaries under the prerequisites specified in sub§

2a,

5. are intended for use in clinical trials on animals or in residue tests, or

6. are made available free of charge under the conditions specified to in Article 83 of Regulation

(EC) No. 726/2004 for administration to patients with a seriously debilitating disease

or whose disease is life-threatening, and who cannot be treated satisfactorily with

an authorised medicinal product; this applies equally to medicinal products which do not

fall under the categories stipulated in Article 3 first or second paragraph of Council Regulation

(EC) No. 726/2004; rules of procedure shall be specified in an ordinance pursuant

to § 80.

(2a) Medicinal Products which contain substances and preparations from substances

which have not been released for trade outside of pharmacies, may only be manufactured pursuant

to sub-§ 2 number 4 if a medicinal product authorised for the treatment of the animal

species in question or for the specific therapeutic indications is not available, if the necessary

medicinal treatment of the animals would otherwise be seriously jeopardized and if no direct

or indirect danger to the health of human beings and animals is to be feared. The manufacture

of medicinal products pursuant to sentence 1 is only admissible in pharmacies. Sentence

2 does not apply to the preparation of medicinal product from a finished medicinal product and

medically non-active constituents nor to the mixing of finished medicinal products intended for

the immobilisation of zoo, wild and reserve animals. For the purposes of sentence 1, the decanting,

packaging or labelling of medicinal products in unchanged form shall not be considered

as manufacturing, in so far as:

1. no finished medicinal products are available commercially in package sizes suitable for

the individual case, or

2. in other cases, the container or any other form of pharmaceutical packaging coming into

direct contact with the medicinal product is not damaged.

 

Sentences 1 to 4 shall not apply to homeopathic medicinal products which are either

registered or exempt from registration and, should they be intended for use in food-producing

animals, if they contain only the active substances included in the list in Annex II of Regulation

(EEC) No. 2377/90.

(3) Application for a marketing authorisation shall be made by the pharmaceutical entrepreneur.

For a finished medicinal product manufactured in pharmacies or at other retail dealers

using standardized procedures, and distributed to the consumer under a standardized name,

the application for a marketing authorisation shall be made by the party responsible for the issue

of the master formula. If a finished medicinal product is manufactured for several pharmacies

or other retail dealers and is to be distributed to the consumer under their name and under

a standardized name, then the manufacturer shall apply for the marketing authorisation.

(4) Furthermore, upon request by the competent authority of the Land, the competent

higher federal authority shall decide on the obligation to obtain a marketing authorisation for a

specific medicinal product, irrespective of an application for a marketing authorisation pursuant

to sub-§ 3.

§ 21a

Authorisation of tissue preparations

(1) Tissue preparations which are not manufactured involving an industrial process and

the essential processing procedures of which are sufficiently well known in the European Union,

and the effects and side effects of which are known and evident from scientific data may

only be placed on the market within the purview of the present Act, if they have been authorised

by the competent higher federal authority, by way of derogation from the marketing authorisation

obligations pursuant to § 21 sub-§ 1. This shall also apply to tissue

preparations the processing procedures for which are new but comparable with a known procedure.

Sentence 1 shall apply mutatis mutandis to blood stem cell preparations intended for

autologous use or for targeted administration to a specific person. The authorisation shall cover

the procedures for the procurement, processing and testing, the choice of donors and the

documentation for each operational step as well as the quantitative and qualitative criteria for

tissue preparations. Especially the critical processing procedure must be evaluated to ascertain

that the procedures do not render the tissues clinically ineffective or harmful to patients.

(1a) An authorisation pursuant to sub-§ 1 is not required for tissue preparations

which are intended for clinical trials on human beings.

 

(2) The application for an authorisation shall be accompanied by the following information

and documents to be supplied by the applicant:

1. the name or the company and the address of the processor,

2. the name of the tissue preparation,

3. the therapeutic indications as well as the method of administration and, in the case of tissue

preparations which are intended to be used for a limited period of time, the duration

of the application,

4. information about the procurement and laboratory testing of the tissues, as well as the

processing, preservation, testing and storage of the tissue preparation,

5. the type of preservation, the shelf life, and the conditions for storage,

6. a description of the functionality and the risks of the tissue preparation,

7. documents containing the results of microbiological, chemical and physical examinations

and the methods used in their determination, in so far as these documents are necessary,

as well as

8. all of the information and documents which is relevant to the purpose of evaluation of the

medicinal product.

§ 22 sub-§ 4 shall apply mutatis mutandis.

(3) In respect of the information pursuant to sub-§ 2 number 3, scientific findings

which are also able to compare with empirical medical findings prepared according to scientific

methods can be submitted. These could include studies conducted by the manufacturer of the

tissue preparation, data from publications or subsequent assessments of the clinical findings on

the manufactured tissue preparations.

(4) The competent higher federal authority shall reach a decision on the application for

an authorisation within five months. If the applicant is given the opportunity to correct flaws, the

deadlines shall be interrupted until such flaws have been corrected or until the expiry of the

deadline set for the correction of the flaws. The interruption of the deadline shall begin on the

day the applicant receives the request to correct the flaws.

 

(5) The competent higher federal authority shall grant the authorisation in writing, together

with an authorisation number. The authority may combine the authorisation with the imposition

of conditions. § 28 shall apply mutatis mutandis.

(6) The competent higher federal authority may only refuse an authorisation if:

1. the documents submitted are incomplete,

2. the tissue preparation does not correspond to the current state of scientific knowledge, or

3. the tissue preparation does not fulfil the envisaged function or the benefit-risk ratio is unfavourable.

(7) The applicant, or subsequent to the authorisation, the holder of the authorisation

shall immediately notify the competent higher federal authority of any changes in the information

pursuant to sub-§s 2 and 3 and include the corresponding documents with the notification.

In the event of a change in the documents pursuant to sub-§ 3, the change may

only be carried out if the competent higher federal authority has consented.

(8) The authorisation shall be withdrawn if it subsequently becomes known that one of

the grounds for refusal, pursuant to sub-§ 6 numbers 2 and 3 existed at the time the authorisation

was granted. The authorisation shall be revoked if one of the grounds for refusal

subsequently developed. In both cases, the temporary suspension of the authorisation may

also be ordered. Before a decision is reached pursuant to sentences 1 to 3, the holder of the

authorisation shall be heard unless danger is imminent. If the authorisation has been withdrawn,

revoked or suspended, the tissue preparation may not be placed on the market, nor

shall it be introduced into the purview of the present Act.

(9) By way of derogation from sub-§ 1, tissue preparations which are allowed to

be placed on the market in a Member State of the European Union or in another State Party to

the Agreement on the European Economic Area, shall require a certificate from the competent

higher federal authority before the first placing on the market within the purview of the present

Act. Before issuing the certificate, the competent higher federal authority shall examine whether

the processing of the tissue preparations meet the requirements with respect to the removal

and processing procedures including the donor selection procedures and the laboratory examinations,

and whether the quantitative and qualitative criteria for the tissue preparations meet

the requirements of the present Act and its ordinances. The competent higher federal authority

 

must issue the certificate if the authorisation certificate or another certificate from the competent

authority of the country of origin demonstrates the equivalence of the requirements pursuant

to sentence 2 and the proof of authorisation in the Member State of the European Union or

in another State Party to the Agreement on the European Economic Area is submitted. The

competent higher federal authority shall be informed on time of any change in the requirements

pursuant to sentence 2 prior to any further introduction of the tissue preparation into the purview

of the present Act. The certificate is to be withdrawn if one of the prerequisites pursuant to

sentence 2 had not been met; it shall be revoked if one of the prerequisites pursuant to sentence

2 is, subsequently, no longer met.

§ 22

Marketing authorisation documents

(1) The applicant shall attach the following information to his/her application for a marketing

authorisation:

1. the name or the company and the address of the applicant and the manufacturer,

2. the name of the medicinal product,

3. the constituents of the medicinal product by type and quantity; § 10 sub-§ 6

shall apply,

4. the pharmaceutical form,

5. the effects,

6. the therapeutic indications,

7. the contra-indications,

8. the side effects,

9. the interactions with other products,

10. the dosage,

11. information on the medicinal product's manufacture,

12. the method of administration and, in the case of medicinal products which should only be

administered for a limited period of time, the duration of the administration,

13. the package sizes,

14. the method of preservation, shelf-life, storage conditions, results of stability tests,

15. the methods of quality control (test methods).

(1a) The information pursuant to sub-§ 1 sentence 1 numbers 1 to 10 must be

provided in the German language, the other information in German or in English; other information

or documents can also be provided or submitted in English instead of in German, within the

 

framework of the marketing authorisation procedure, in so far as information for use in the labelling,

the package leaflet or the expert information are not concerned.

(2) Furthermore, the following information shall be submitted:

1. the results of physical, chemical, biological or microbiological examinations and the

methods used in their determination (analytical test),

2. the results of the pharmacological and toxicological tests,

3. the results of clinical trials or other medical, dental or veterinary tests,

4. a statement to the effect that clinical trials conducted outside the European Union were

conducted under ethical conditions which are equivalent to the ethical conditions laid

down in Directive 2001/20/EC of the European Parliament and of the Council of 4th April

2001 on the approximation of the laws, regulations and administrative provisions of the

Member States relating to the implementation of good clinical practice in the conduct of

clinical trials on medicinal products for human use (OJ L 121 of 1.5.2001, p. 34),

5. a detailed description of the pharmacovigilance and, if applicable, the risk management

system which the applicant will introduce,

6. evidence that the applicant has access to a qualified person pursuant to § 63a who

is equipped with the necessary resources to perform the duties referred to in § 63b,

7. a copy of each orphan medicinal product designation pursuant to Regulation (EC) No.

141/2000 of the European Parliament and of the Council of 16th December 1999 on orphan

medicinal products (OJ L 18 p. 1).

The results pursuant to sentence 1 numbers 1 to 3 shall be substantiated by documentary

evidence in such a way that the type, scope and exact time of the tests are clearly evident.

The application for a marketing authorisation shall be accompanied by all of the relevant information

and documents necessary for the assessment of the medicinal product, whether favourable

or unfavourable. This shall also apply to incomplete or discontinued toxicological or

pharmacological experiments or clinical trials carried out using the medicinal product in question.

(3) Instead of the results specified in sub-§ 2 numbers 2 and 3, other scientific

documents may be presented:

 

1. in the case of a medicinal product which contains active substances that have been used

for at least ten years in the European Union for general medical or veterinary purposes,

the effects and side effects of which are known and evident from scientific data,

2. in the case of a medicinal product which, in its composition, is comparable to a medicinal

product pursuant to number 1,

3. for the constituents of the medicinal product, in the case of a medicinal product which is a

new combination of constituents which are already known; however, other documents

containing scientific findings may also be presented for the combination as such, if the efficacy

and safety of the medicinal product according to its composition, dosage, pharmaceutical

form and therapeutic indications can be determined by these documents.

Furthermore, the medical experience gained by the specific schools of therapy must

also be taken into consideration.

(3a) If the medicinal product contains more than one active substance, evidence shall

be provided to prove that every active substance contributes to the positive assessment of the

medicinal product.

(3b) In the case of radiopharmaceuticals which are generators, a general description of

the system, including a detailed description of those components of the system which are able

to influence the composition or quality of the secondary radioactive nuclide preparation, as well

as the particular qualitative and quantitative characteristics of the eluate or the sublimate, are to

be provided.

(3c) Documents should also be submitted for the evaluation of possible environmental

risks and if the storage of the medicinal product or its administration or the disposal of its waste

requires special safety precautions or measures to avoid endangering the environment or impairing

the health of human beings, animals or plants, this shall also be stated. Information on

how to reduce these dangers shall also be submitted and substantiated. In the case of medicinal

products intended for use in animals, the results of the tests to evaluate possible environmental

risks shall be submitted; sub-§ 2 sentences 2 to 4 shall apply mutatis mutandis.

(4) If an application is made for a marketing authorisation in respect of a medicinal

product manufactured within the purview of the present Act, proof shall be furnished that the

manufacturer is entitled to manufacture the medicinal product. This shall not apply in the case

of an application pursuant to § 21 sub-§ 3 sentence 2.

 

(5) If an application is made for a marketing authorisation in respect of a medicinal

product manufactured outside the purview of the present Act, proof shall be furnished that the

manufacturer is entitled to manufacture medicinal products in accordance with the legal regulations

laid down by the country of manufacture and, in the event that the medicinal product is

imported from a country which is not a Member State of the European Union or a State Party to

the Agreement on the European Economic Area, that the importer is in possession of an authorisation

to import the medicinal product into the territory governed by the present Act.

(6) If the medicinal product has already been granted a marketing authorisation in another

state or in several other states, a copy of such authorisation shall be included. Where an

application for a marketing authorisation has been denied in whole or in part, the details of that

decision shall be furnished and the grounds for it explained. Where an application for a marketing

authorisation is currently being examined in one or several Member States of the European

Union, this shall be stated. Copies of the summaries of the product characteristics and package

leaflets authorized by the competent authorities of the Member States or, where these documents

are not available, the versions of these documents proposed by the applicant in the

course of a procedure pursuant to sentence 3, shall also be included. Furthermore, where an

application for the recognition of the marketing authorisation of another Member State is submitted,

the declarations required under Article 28 of Directive 2001/83/EC or in Article 32 of Directive

2001/82/EC shall be submitted along with the other information stipulated therein. Sentence

5 shall not apply to medicinal products which have been manufactured according to homeopathic

manufacturing procedures.

(7) The application for a marketing authorisation shall be accompanied by the wording

of the information which is meant to appear on the container, the outer packaging and the

package leaflet as well as by the draft of the Summary of Product Characteristics which shall

also represent the expert information pursuant to § 11a sub-§ 1 sentence 2, where

such expert information is stipulated. In the case of medicinal products intended for administration

to human beings, the results of evaluations of the package leaflet conducted in collaboration

with patient target groups shall also be submitted to the competent higher federal authority.

The competent higher federal authority may require the submission of one or more samples or

mock-ups of the sales presentation of the medicinal product, including the package leaflets, as

well as starting materials, intermediate products and substances which are used in the manufacture

or testing of the medicinal products, in a quantity sufficient to conduct the test and in a

state suitable to the conduct of said test.

§ 23

 

Particular documents required for medicinal products intended

for administration to animals

(1) In respect of medicinal products intended for administration to food-producing animals,

the following information shall be given in addition to those specified in § 22:

1. information about the withdrawal period shall be given and shall be substantiated by

documents on the results of the residue tests and particularly on the fate of the pharmacologically

active constituents and their metabolic products in the animal body and on the

influence on foodstuffs of animal origin, in so far as these results are necessary for the

assessment of withdrawal periods taking stipulated maximum levels into account, and

2. in the case of a medicinal product with a pharmacologically active constituent not listed in

Annex I, II or III of Regulation (EEC) No. 2377/90, a certificate confirming that an application

pursuant to Annex V for the establishment of maximum residues pursuant to the

aforementioned Regulation had been submitted to the European Medicines Agency at

least 6 months previously, and

3. (deleted)

Sentence 1 number 2 shall not apply if § 25 sub-§ 2 sentence 5 applies.

(2) In the case of medicated pre-mixes, the particulars of the mixed feed intended as

carrier shall be given with the designation of the type of feedingstuff. Furthermore, it shall be

justified and proved by documents that the medicated pre-mixes are suited for the intended

manufacture of the medicated feedingstuff, and particularly that they allow a homogeneous and

stable distribution of the active substances in the medicated feedingstuffs taking into consideration

the manufacturing methods applied in the production of mixed feed; furthermore, the shelflife

of medicated feedingstuffs shall be indicated, grounds provided and proved by documents.

Moreover, a routine test method suitable for the quantitative and qualitative analysis of the active

substances in the medicated feedingstuffs, shall be described and documents on test results

submitted as proof.

(3) The nature and scope of as well as the date on which the tests were carried out shall

be inferable from the documents containing the results of the residue tests and the residue test

procedures pursuant to sub-§ 1, as well as from the evidence regarding the suitability of

the medicated pre-mixes for the intended manufacture of the medicated feedingstuff and the

 

test results of the test methods pursuant to sub-§ 2. Instead of the documents, the evidence

and test results referred to in sentence 1, other scientific findings may be submitted.

§ 24

Expertises

(1) Expertises in which the test methods, test results and residue test procedures are

summarized and assessed, shall be included with the required documents pursuant to §

22 sub-§ 1 number 15, sub-§s 2 and 3 and § 23. In particular, the following

information shall be included in detail in the expertises presented:

1. the analytical expert opinion shall state whether the medicinal product is of appropriate

quality in accordance with recognized pharmaceutical practice, whether the proposed test

methods comply with the prevailing standard of scientific knowledge and are suitable for

quality assessment,

2. the pharmacological-toxicological expert opinion shall state the medicinal product's toxic

effects and pharmacological properties,

3. the clinical expert opinion shall state whether the medicinal product has the required effect

in the specified therapeutic indications, whether it is tolerated, whether the prescribed

dosage is appropriate and which contra-indications and side effects exist,

4. the expert opinion on the residue test shall state whether, and if so, how long after the

administration of the medicinal product, residues occur in the foodstuffs obtained from the

animals which have undergone treatment, how these residues are to be assessed and

whether the prescribed withdrawal period is sufficient.

Moreover, the expert opinion shall state whether the type and quantity of residue present

after the prescribed withdrawal period has elapsed are below the maximum levels stipulated

by Regulation (EEC) No. 2377/90.

(2) In so far as scientific documentation is presented pursuant to § 22 sub-§

3 and § 23 sub-§ 3 sentence 2, it must be evident from the expert opinion, that the

documents on scientific findings were elaborated under analogous application of the Guidelines

for the Testing of Medicinal Products.

 

(3) The expert opinion shall be accompanied by information regarding the name, training

and professional practice of the expert as well as his/her professional relationship with the

applicant. The experts shall confirm with their dated signature that they are the authors of the

expert opinion.

§ 24a

Use of a previous applicant's documents

The applicant can refer to the documents referred to in § 22 sub-§s 2, 3, 3c

and § 23 sub-§ 1, including the expertise report referred to in § 24 sub§

1 sentence 2 submitted by an earlier applicant (previous applicant), if he/she submits

the previous applicant’s written agreement, including confirmation that the documents referred

to meet the requirements of the Guidelines for the Testing of Medicinal Products pursuant to

§ 26. The previous applicant shall respond to a request for agreement, within a period of

three months. A partial reference is not admissible.

§ 24b

Authorisation of a generic medicinal product, document protection

(1) In the case of a generic medicinal product within the meaning of sub-§ 2, reference

can be made, without the previous applicant’s agreement, to the documents referred to

in sentence 1 of § 22 sub-§ 2 sentence 1 numbers 2 and 3 and § 23 sub§

1, including the expert report referred to in § 24 sub-§ 1 sentences 2 to 4

for the previous applicant’s medicinal product (reference medicinal product), provided that the

reference medicinal product has been authorised for at least eight years or was authorised at

least eight years previously; this shall also apply to authorisation in another Member State of

the European Union. A generic medicinal product authorised pursuant to this provision shall not

be placed on the market until ten years have elapsed following the first authorisation of the reference

medicinal product. The period referred to in sentence 2 shall be extended to a maximum

of eleven years if, during the first eight years of authorisation, the marketing authorisation

holder obtains authorisation for one or more new therapeutic indications which during the scientific

evaluation conducted prior to their authorisation by the competent higher federal authority

are held to bring significant clinical benefit in comparison with existing therapies.

(2) Authorisation as a generic medicinal product pursuant to sub-§ 1 shall require

that the medicinal product in question has the same qualitative and quantitative composition of

active substances and the same pharmaceutical form as the reference medicinal product and

that the bioequivalence has been demonstrated in bioavailability studies. The different salts,

 

esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance

shall be considered to be one and the same active substance unless their properties differ significantly

with regard to safety or efficacy. In such cases, the applicant must submit additional

proof of the safety or efficacy of the different salts, esters, ethers, isomers, mixture of isomers,

complexes or derivatives of the active substance. The various immediate release oral pharmaceutical

forms shall be considered to be one and the same pharmaceutical form. The applicant

shall not be required to submit bioavailability studies if he/she can otherwise demonstrate that

the generic medicinal product meets the relevant bioequivalence criteria in accordance with

current scientific knowledge. In cases where the medicinal product does not meet the requirements

of a generic medicinal product or where the bioequivalence cannot be demonstrated

through bioequivalence studies or in the case of a change in the active substance, therapeutic

indication, strength, pharmaceutical form or route of administration vis-à-vis the reference medicinal

product, the results of appropriate preclinical tests or clinical trials shall be provided. In

the case of medicinal products intended for use in animals, the corresponding safety studies

and in the case of medicinal products intended for use in food-producing animals, the results of

corresponding residue tests shall also be submitted.

(3) If the reference medicinal product was not authorised by the competent higher federal

authority but by the competent authority of another Member State, the applicant shall indicate

in the application form, where the reference medicinal product is or has been authorised.

In this case, the competent higher federal authority shall ask the competent authority of the

other Member State to transmit within one month a confirmation that the reference medicinal

product is or has been authorised, together with the full composition of the reference medicinal

product and other documents relevant to the authorisation of the generic medicinal product. In

the case where the reference medicinal product has been authorised by the European Medicines

Agency, the competent higher federal authority shall ask the latter for the information and

documents referred to in sentence 2.

(4) If the competent authority of another Member State where an application is submitted

requests information or documents referred to in sub-§ 3 sentence 2 of the competent

higher federal authority, the latter shall respond to this request within one month, provided that

at least eight years have elapsed since the reference medicinal product was first authorised.

(5) Where a biological medicinal product which is similar to a biological reference medicinal

product does not meet the conditions for generic medicinal products, referred to in sub§

2 owing to, in particular, differences relating to raw materials or differences between the

manufacturing processes of the biological medicinal product and the reference biological medicinal

product, the results of appropriate preclinical tests or clinical trials relating to these de-

72 -

viations must be provided. The type and quantity of the supplementary data to be provided

must comply with the relevant criteria according to current scientific knowledge. The results of

other tests from the documents submitted for the reference medicinal product’s authorisation

shall not be provided.

(6) In addition to the provisions laid down in sub-§ 1, where an application is made

for a new therapeutic indication for a known active substance that has been in general medical

use for at least ten years in the European Union, a non-cumulative period of one year of data

exclusivity shall be granted for the data gained from significant preclinical or clinical studies carried

out in connection with the new therapeutic indication.

(7) Sub-§ 1 sentence 3 and sub-§ 6 shall not apply to generic medicinal

products intended for use in animals. The period referred to in sub-§ 1 sentence 2 shall

be extended:

1. to thirteen years in the case of veterinary medicinal products intended for use in fish or

bees,

2. in the case of veterinary medicinal products intended for one or more food-producing

species, containing a new active substance that had not been authorised in the Community

by 30th April 2004, by one year for each extension of the marketing authorisation to

another food-producing species which takes place within the five years following the

granting of the initial marketing authorisation. This period shall not, however, exceed a total

of thirteen years for a marketing authorisation for four or more food-producing species.

The prolongation of the ten-year period to eleven, twelve or thirteen years for a veterinary

medicinal product intended for a food-producing species shall be granted only if the marketing

authorisation holder also originally applied for the setting of maximum residues limits for

the species covered by the authorisation.

(8) If the extension of a marketing authorisation is for a veterinary medicinal product registered

pursuant to § 22 sub-§ 3 and relates to a food-producing species and was

obtained on submission of new residue tests pursuant to Regulation (EEC) No. 2377/90 and

new clinical trials, the data obtained in the aforementioned tests shall be covered by an exclusivity

period of three years after the granting of the authorisation.

§ 24c

Additional requests

 

If several holders of a marketing authorisation have to be requested to submit additional

documents, the competent higher federal authority shall notify every holder of a marketing authorisation

of the documents necessary for the further assessment as well as of the names and

addresses of the other holders of a marketing authorisation who are involved. The competent

higher federal authority shall give those holders of the marketing authorisation who are involved

the opportunity to decide among themselves as to who will submit the documents within a period

of time to be determined by the authority. If an agreement is not reached, the competent

higher federal authority shall de