GERMAN DRUG LAW

This section is intended to  give you an impression of the content of the German Drug Law, "Arzneimittelgesetz" or "AMG".

First you find all the paragraphs listed, following there is a translation of most of   text of the first 20 paragraphs.

Unfortunately the law is not up to date, it reflects the law as of  1994. But it still gives you an impression of the intention and the general content of the law and especially all our answers will be based on today´s situation and be valid for tomorrow!

If you need more information on that subject, want some of the paragraphs that are not yet translated,  or have any other question, please feel free to contact us.

Contents

Article 1
Drug Law
First Section
Purpose of the Law and Definitions

§ 1 Purpose of the law
§ 2 Definition of drugs
§ 3 Definition of substances
§ 4 Other definitions

Second Section
Drug Requirements

§ 5 Prohibition in respect of unsafe drugs
§ 6 Empowerment in respect of health protection
§ 7 Radioactive drugs and drugs treated with ionizing radiation
§ 8 Prohibitions in respect of prevention of deceit
§ 9 Party responsible for the marketing of a drug
§ 10 Labelling of finished drugs
§ 11 Package leaflet
§ 11 a Information sheet for experts
§ 12 Empowerment in respect of drug labeling, package leaflet, and package sizes

Third Section
Manufacture of Drugs

§ 13 Manufacturing authorization
§ 14 Decision on the manufacturing authorization
§ 15 Expert knowledge
§ 16 Limitation of the manufacturing authorization
§ 17 Fixed periods for the granting of an authorization
§ 18 Withdrawal, Revocation, Suspension
§ 19 Scopes of responsibility
§ 20 Obligations of notification

Fourth Section
Marketing Authorization for Drugs

§ 21 Obligation to obtain a marketing authorization
§ 22 Documents required for marketing authorization
§ 23 Particular documents for drugs intended for application to animals
§ 24 Expertises
§ 24 a Use of documents of a previous applicant
§ 24 b Requests for additional documents
§ 24 c General exploiting authorization
§ 25 Decision on marketing authorization
§ 25 a Pre-examination§ 26 Guidelines for the testing of drugs
§ 27 Fixed periods given for the granting
§ 28 Authority to impose conditions
§ 29 Obligation of notifications, Renewal of the marketing authorization
§ 30 Withdrawal, Revocation, Suspension
§ 31 Expiration
§ 32 Official batch testing
§ 33 Costs
§ 34 Promulgation
§ 35 Empowerments in respect of marketing authorization and exemptions
§ 36 Empowerment in respect of standard marketing authorizations
§ 37 Marketing authorizations for drugs issued in other countries

Fifth Section
Registration of Homeopathic Drugs

§ 38 Obligation to have a drug registered and documents required for registration
§ 39 Decision on the drug registration

Sixth Section
Protection of the Human Being during the Clinical Trial

§ 40 General preconditions
§ 41 Special conditions
§ 42 Exceptions

Seventh Section
Drug Supply

§ 43 Obligation to supply drugs in pharmacies only, Marketing of drugs by veterinarians
§ 44 Exceptions to the obligation to supply drugs in pharmacies only
§ 45 Empowerment in respect of further exceptions to the obligation to supply drugs in pharmacies only
§ 46 Empowerment in respect of extension of the obligation to supply drugs in pharmacies only
§ 47 Channel of distribution
§ 48 Prescription requirement
§ 49 Automatic prescription requirement
§ 50 Retail trade in over-the-counter drugs
§ 51 Drug supply in itinerant trading
§ 52 Prohibition of self-service
§ 53 Expert consultation

Eight Section
Quality Assurance and Control

§ 54 Operation ordinances
§ 55 Pharmacopoeia
§ 55a Official collection of test procedures

Ninth Section
Special Regulations for Drugs Intended
for Administration to Animals

§ 56 Medicated feeding stuffs
§ 56 a Prescription, distribution and administration of drugs by veterinarians
§ 57 Acquisition by animal owners
§ 58 Administration to animals serving the production of food
§ 59 Clinical trial and residue test on animals serving the production of food
§ 59 a Trade in substances and preparations from substances
§ 59 b Residue test procedures
§ 60 Pet animals
§ 61 Authority of veterinary schools

Tenth Section
Observation, Compilation and Evaluation
of Drug Risks

§ 62 Organization
§ 63 Graduated plan
§ 63 a Commissioner for the graduated plan

Eleventh Section
Supervision

§ 64 Execution of supervision
§ 65 Sampling
§ 66 Obligation of tolerance and collaboration
§ 67 General obligation of notification
§ 68 Obligation of communication and information
§ 69 Measures to be taken by the competent authorities

Twelfth Section
Special Provisions with Regard to the Federal Army,
the Federal Border Guard, the Alert Police and Civil Defence

§ 70 Application and execution of the law
§ 71 Exceptions

Thirteenth Section
Import and Export

§ 72 Import authorization
§ 72 a Certificates
§ 73 Prohibition of introduction
§ 73 a Export
§ 74 Participation of customs offices

Fourteenth Section
Pharmaceutical Consultant

§ 74 a Representative for information, pharmaceutical consultant
§ 75 Expert knowledge
§ 76 Obligations

Fifteenth Section
Designation of the Competent Federal
Higher Authorities and Other Provisions

§ 77 Competent federal higher authority
§ 78 Prices
§ 79 Exceptional empowerments in times of crises
§ 80 Exceptions regarding the field of application of this law
§ 81 Relation to other laws
§ 82 General administrative regulations
§ 83 Approximation to community legislation

Sixteenth Section
Liability for Damages Caused by Drugs

§ 84 Absolute liability
§ 85 Contributory negligence
§ 86 Extent of liability for compensation in case of death
§ 87 Extent of liability for compensation in case of bodily injury
§ 88 Maximum amounts
§ 89 Compensation by annuities
§ 90 Limitation of action
§ 91 Extended liability
§ 92 Mandatory provision
§ 93 Several parties liable for compensation
§ 94 Coverage provision
§ 94 a Local jurisdiction

Seventeenth Section
Penal Provisions and Provisions on Administrative Fines

§ 95 Penal provisions
§ 96 Penal provisions
§ 97 Administrative fines
§ 98 Confiscation

Article 1

Drug Law

First Section

Purpose of the Law and Definitions

§1

Purpose of the law

It is the purpose of this law to guarantee, in the interest of a proper supply of drugs to humans and animals, security in respect of the trade in drugs, ensuring in particular the quality, efficacy and safety of drugs in accordance with the following provisions.

§2

Drugs are substances and preparations made from substances which, by application on or in human or animal body, are intended

1. to cure, alleviate, prevent or diagnose diseases, suffering, bodily injury or sickness symptoms,
2. to diagnose the nature, the state or the functions of the body or the mental health conditions,
3. to substitute active substances or body fluids produced in the human or animal body,
4. to ward off pathogens, parasites or substances alien to the body or to destroy them or to render them harmless,
5. to influence either the nature, the state or the functions of the body or the mental health conditions.

§4

Other definitions

 Finished drugs are drugs which are manufactured beforehand and then marketed in packages ready for distribution to the consumer.

Blood preparations are drugs which are or which contain conserves of blood, plasma or serum, obtained from blood, blood constituents or preparations made from blood constituents.

Sera are drugs as defined in §2 para 1 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 preciously immunized, which contain specific antibodies and which are intended for use on account of these antibodies. Sera shall not be considered as blood preparations as defined in para 2.

Vaccines are drugs as defined in §2 para 1, containing antigens and intended for use in human beings or animals for the production of specific antitoxins and protective agents.

Test allergens are drugs as defined in §2 para 1, containing antigens or haptens and intended to be used on human beings or animals for the diagnosis of specific antitoxins or protective agents.

Test sera are drugs as defined in §2 para 2 sub-para 4 letter a, 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 antibodies and which are intended to be used on account of these antibodies, as well as the appertaining control sera.

Test antigens are drugs as defined in §2 para 2 sub-para 4 letter a, which contain antigens or haptens and which are intended to be used as such.

Radioactive drugs are drugs 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 are intended for radiolabelling of other substances prior to application as well as systems which are intended for the production of radioactive drugs using a fixed parent radionuclide which forms a daughter radionuclide (generators) shall also be regarded as radioactive drugs.

Dressings are items intended to cover injured surface parts of the body or to absorb their body fluids.

Premix drugs are drugs intended for use in the manufacture of medicated feeding stuffs.

Withdrawal period is the time during which, under correct application of a drug on animals, residues of a type and quantity not innocuous to health, particularly of a quantity which exceeds defined maximum amounts, must be anticipated in the foodstuffs to be obtained from the animals undergoing treatment, and includes an appropriate safety margin.

Side effects are undesired reactions occurring under correct use of a drug.

Manufacturing means producing, preparing, formulating, treating and processing, filling as well as decanting, packaging and labelling.

Quality is the mature of a drug, determined by identity, content, purity and other chemical, physical and biological properties or by the manufacturing process.

A batch is the quantity of a drug manufactured in one complete manufacturing process.

Marketing is the keeping in stock for sale or for other forms of supply, the keeping and offering for sale and the distribution to others.

A pharmaceutical entrepreneur is any person placing drugs under his own name on the market.

Active substances are substances which are intended to be used as medically active constituents for the manufacture of drugs.

Second Section

Drug Requirements

§5

Prohibition in respect of unsafe drugs

It shall be prohibited to market unsafe drugs.

As unsafe shall be considered drugs which, in the light of scientific knowledge currently prevailing, under correct and stipulated use, are justifiably suspected of having harmful effects that exceed the bounds considered justifiable in the light of the knowledge of medical science.

§6

Empowerment in respect of health protection

The Federal Ministry of Health (Federal Ministry) shall be empowered with regard to the manufacture of drugs to specify, restrict or prohibit, by ordinance subject to the consent of the Federal Council, the use of certain substances, preparations made from substances or items and to forbid the marketing of drugs, which have not been manufactured in compliance with these regulations as far as this is deemed necessary in order to prevent a direct or indirect hazard to human or animal health by drugs.

§8

Prohibitions in respect of prevention of deceit

It shall be prohibited to manufacture or to market drugs

1. which, by deviations from recognized pharmaceutical principles, are significantly diminished in their quality, or
2. which bear misleading designations, specifications or presentation. Deceit shall in particular be existent if

1. a theurapeutic efficacy or effects are attributed to drugs which they do not possess,
2. the impression is fraudulently given that success can be anticipated for sure or that, under correct use or under use of a longer duration no harmful effects occur,
3. in an attempt to make fraudulently statements on quality, designations, specifications or presentation are employed which are a determinant factor for the assessment of the drug.

It shall be prohibited to market drugs whose expiration date has elapsed.

§9

Party responsible for the marketing of a drug

Drugs which are placed on the market within the purview of this law shall bear the name or the company and the address of the pharmaceutical entrepreneur.

Within the purview of this law drugs may only be placed on the market by a pharmaceutical entrepreneur whose place of business is situated within the purview of this law, in another Member State of the European Communities or in another contraction state of the Agreement on the European Market.

§10

Labelling of finished drugs

(1)  Finished drugs which are drugs as defined in §2 para 1 or para 2 sub-para 1, may only be marketed within the purview of this law provided that the following particulars are displayed on the containers and, id used, on the outer packages, in easily legible and indelible characters, intelligibly in German language:

1. the name or the company and the address of the pharmaceutical entrepreneur,
2. the name of the drug; if the drug is placed on the market in different pharmaceutical forms or strengths, the name of the drug shall be followed by information on the pharmaceutical form, the strength, or the group of persons the drug is intended for unless this information is already included in the name.
3. the marketing authorization number with the abbreviation "A Zul.-Nr.",
4. the batch identification if the drug is placed on the market in batches, with the abbreviation "Ch.-B.", if it cannot be marketed in batches, the date of manufacture,
5. the pharmaceutical form,
6. the content by weight, volume or number of pieces,
7. the method of administration,
8. the pharmaceutically active constituents by type and quantity, and other constituents y type as far as this is imposed in the conditions issued by the competent federal higher authority pursuant to §28 para 2 sub-para 1 or prescribed by ordinance pursuant to §12 para 1 sub-para 4 or §36 para 1; all constituents by type as far as drugs are concerned which are intended for injection of for topical use, including drugs which are intended for the use on the eyes. In the case of gene-technologically manufactured drugs the active substance and the designation of the micro-organism or the cell line which have been gene-technologically modified during the manufacture,
9. the expiration date with the instruction "to be used until",
10. in the case of drugs which may only be supplied upon prescription by a physician, dentist or veterinarian, the indication "Verschreibungspflichtig" (prescription-only), in the case of other drugs which may only be supplied to consumers in pharmacies, the indication "Apothekenpflichtig" (pharmacy-only),
11. in the case of samples, the indication "unverkäufliches Muster" (sample-not for sale),
12. the indication that drugs shall be kept out of reach for children unless they are curative waters,
13. specific precautions for the disposal of drugs which have not been used as far as necessary.

(2) - (9) -->   Part of this paragraph is missing

(10) For drugs intended for clinical trial or residue testing, para (1) sub-paras 1, 2 and 4 to 7 as well as paras 8 and 9 shall be applicable, inasmuch as they are relevant. Drugs intended for clinical trial shall be labelled ,Zur klinischen Prüfung bestimmt" (for clinical trial) and drugs intended for residue testing shall be labelled ,Zur Rückstandsprüfung bestimmt" (for residue testing). As far as an authorized drug shall be labelled ,Zur klinischen Prüfung bestimmt" (for clinical trial) pursuant to sentence 2, it is refrained from the indication of the name under which it is authorized and it shall bear a name deviating from the authorized designation. Pushout packages shall be given with the name and the batch designation; sentences 2 and 3 shall apply accordingly.

§11

Package leaflet

Finished drug products which are drugs as defined in §2 para 1 or para 2 sub-para 1 and are intended neither for clinical trial nor residue testing may only be marketed within the purview of this law with a package leaflet bearing the heading "Gebrauchsinformation" (instructions for use) and containing, in easily legible characters and in the following order, the following order, the following information intelligibly written in German language:

1. the name of the drug; §10 sub-para 2, para 1a and para 10 sentence 3 shall apply accordingly,
2. the pharmaceutically active constituents by type and quantity and all other constituents by type; §10 para 6 shall apply,
3. the pharmaceutical form and the content by weight, volume, or number of pieces,
4. the group of substances or the group of indications or the action mechanisms,
5. the name or the company and the address of the pharmaceutical entrepreneur and of the manufacturer who released the finished drug to be put on the market,
6. the ranges of application,
7. the contra-indications,
8. the precautions for the use as far as they are necessary according to the presently prevailing standard of scientific knowledge,
9. the interactions with other products as far as they can influence the action of this drug,
10. warnings, in particular as far as t his is imposed in the conditions issued by the competent federal higher authority pursuant to §28 para 2 sub-para 2 or prescribed by ordinance,
11. the dosage instructions with type of application, single or daily doses, and, in the case of drugs which should be administered for a limited period of time, the duration of the administration,
12. instructions which have to be followed in case of overdosage or omitted administration or indications of the risks of undesired effects in case of discontinuance as far as necessary,
13. instructions which have to be followed in case of overdosage or omitted administration or indications of the risks of undesired effects in case of discontinuance as far as necessary,
14. the indication that the drug should not be used once the expiration date has elapsed which is given on the container and on the outer package, and, as far as necessary the information on the shelf life after the user has opened the container or made the preparation ready to use, and the warning regarding specific visible signs indication that the drug should not be used any more,
15. the date of the edition of the package leaflet.

§11a

Information sheet for experts

The pharmaceutical entrepreneur shall be obliged to make available upon request to physicians, dentists, veterinarians, pharmacists, and, if the drugs are not subject to prescription, to other persons professionally practising medicine or dentistry, instructions for use by experts (information sheet for experts) on finished drugs which are subject to obtain a marketing authorization or which are exempted from marketing authorization, which are drugs under the terms of §2 para1 or para 2 sub-para 1 and which are not released for trade outside of pharmacies. These instructions for use shall bear the heading "Fachinformation" (information sheet for experts) and include the following details, written in easily legible characters:

Third Section

Manufacture of Drugs

§13

Manufacturing authorization

Anyone intending to manufacture drugs as defined in §2 para 1 or para 2 sub-para 1, test sera, test antigens, surgical suture material, or active ingredients, which are of human or animal origin or are produced by genetechnological procedures, on a commercial or professional basis for distribution to others shall require authorization by the competent authority.

This shall also apply to artificial persons, non-incorporated associations and societies established under civil law, who manufacture drugs for distribution to their members. Distribution to others, in the meaning of sentence 1, shall exist if the person manufacturing the drug is not the same as the person using it.

§15

Expert knowledge

Proof of the required expert knowledge on the part of the production manager or control manager shall be furnished by

1. the licence to practise as a pharmacist, or
2. the diploma for pharmacy, chemistry, biology, human or veterinary medicine attained upon completion of university studies and a period of at least two years’ practical experience in the manufacture or testing of drugs.

In the cases specified in para 1 sub-para 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,

pharmaceutical chemistry,

biochemistry,

physiology,

microbiology,

pharmacology,

pharmaceutical technology,

toxicology,

pharmaceutical biology.

The theoretical and practical instruction and a sufficient knowledge may be acquired at a university also upon completion of university studies under the terms of para 1 sub-para 2 and may be proved by examination.

Para 2 shall not apply to the manufacture and testing of blood preparations, sera, vaccines, test allergens, test sera and test antigens. In place of the evidence of practical experience in the field of medical serology or medical microbiology. For packaging and labelling the prerequisites specified in para 1 shall remain applicable.

From 17 August 1995:

Para 2 shall not apply to the manufacture and testing of blood preparations, sera vaccines, test allergens, test sera and test antigens. In place of the evidence of practical experience pursuant to para1, proof shall be furnished of at least three years’ experience in the field of medical serology or medical microbiology and, in case of blood preparations, of additionally one year’s experience in the field of transfusion medicine. For packaging and labelling the prerequisites specified in para 1 shall remain applicable.

The period of practical experience specified in para 1 shall be spent in a firm who has been granted an authorization for the manufacture of drugs by a Member State of the European Communities, by another contracting state of the Agreement on the European Market or by another State with which the mutual recognition of certificates is agreed upon pursuant to § 72a sentence 1 sub-para 1.

The period of practical experience shall not be required for the manufacture of medicated feeding stuffs from premix drugs; para 2 shall not apply.

§16

Limitation of the manufacturing authorization

The authorization shall be issued to the manufacturer for a specific place of operation and for particular drugs and forms of drugs and in cases defined in § 14 para 4, also for a specific place of operation of the commissioned company.

§17

Fixed periods for the granting of an authorization

The competent authority shall reach a decision on the application for an authorization within a period of three months.

If a holder of an authorization applies for the modification of the authorization in respect of the drugs to be manufactured or the premises and equipment as defined by § 14 para1 sub-para 6, the authority shall reach a decision within a period of one month. In exceptional cases, the fixed period shall be extended by further two months. The applicant shall be informed as to the reasons hereof before the expiry of the fixed period.

If the authority gives the applicant the opportunity to remedy deficiencies in accordance with § 14 para 5, the fixed periods shall be interrupted until the elimination of the deficiencies or until the expiry of the period fixed in accordance with § 14 para 5. The interruption shall begin on the day the applicant receives the request to remedy the deficiencies.

§18

Withdrawal, Revocation, Suspension

The authorization shall be withdrawn, if it becomes known subsequently that one of the reasons for refusing, specified in § 14 para 1, existed at the time the authorization was granted. The authorization shall be revoked, if one of the reasons for refusing has subsequently developed; the suspension of the authorization may be ordered instead of its revocation. § 13 para 4 shall apply accordingly.

The competent authority may provisionally order that the manufacture of a drug be discontinued, if the manufacturer does not furnish the proofs required for manufacture and testing. The provisional order may be restricted to one batch.

§19

Scopes of responsibility

The production manager shall be responsible for ensuring that the drugs are manufactured, stored and labelled as well as accompanied by the prescribed package leaflet in compliance with the regulations applicable to the trade in drugs.

The control manager shall be responsible for drugs being tested rot required quality, in compliance with the regulations applicable to the trade in drugs.

§20

Obligations of notification

The holder of an authorization shall notify the competent authority prior to any change in person of the production, control or sales manager, furnishing proof of the requirements specified in § 14 para 1 sub-para 1 to 5, as well as prior to any substantial change in the premises or the equipment of the place of operation featured in the authorization. In the event of an unexpected change in person of production, control or sales manager, due notification shall be made forthwith.

LAW AS OF 1994