MEDICINAL PRODUCTS ACT Act on Advertising in the Field of Health

305 Pages·2014·0.65 MB·English

MEDICINAL PRODUCTS ACT
(The Drug Law)
(Arzneimittelgesetz – AMG)

Act on Advertising in the Field of Health
(Health Services and Products Advertising Act)
(Heilmittelwerbegesetz – HWG)

of the
Federal Republic of Germany

Non-official translation
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Medicinal Products Act
(The Drug Law)∗

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 en-
tered into force on 28th December 2006,

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

13. Article 1 of the Ordinance of 29th November 2010 (Federal Law Gazette I p. 1752), which
entered into force on 9th December 2010,

14. Article 7 of the Law of 22nd December 2010 (Federal Law Gazette I p. 2262), which en-
tered into force on 1st January 2011,

15. Article 1 of the Law of 25th May 2011 (Federal Law Gazette I p. 946), which entered into
force on 31st May 2011,

* The Sixteenth Act Amending the Medicinal Products Act of 10th October 2013 (Federal Law Gazette I p. 3813) is already incor-
porated in this version. The amendments to the present Act shall enter into force, subject to the provisions contained in Article 2 (2)
(authorisation to issue ordinances having the force of law), on 1st April 2014.
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16. Article 1 of the Ordinance of 19th July 2011 (Federal Law Gazette I p. 1398) which en-
tered into force on 26th July 2011,

17. Article 13 of the Law of 22nd December 2011 (Federal Law Gazette I p. 2983) which en-
tered into force on 29th December 2011,

18. Article 1 of the Ordinance of 16th July 2012 (Federal Law Gazette I p. 1534) which en-
tered into force on 24th July 2012,

19. Articles 1 and 2 of the Law of 19th October 2012 (Federal Law Gazette I p. 2192) which
entered into force on 26th October 2012,

20. Article 4 of the Law of 21st March 2013 (Federal Law Gazette I p. 566) which entered into
force on 29th March 2013,

21. Article 1 of the Ordinance of 25th March 2013 (Federal Law Gazette I p. 627) which en-
tered into force on 9th April 2013,

22. Article 5 (1) of the Law of 20th April 2013 (Federal Law Gazette I p. 868) which entered
into force on 25th April 2013,

23. Article 1 of the Ordinance of 24th June 2013 (Federal Law Gazette I p. 1687) which en-
tered into force on 29th June 2013,

24. Article 2 of the Law of 15th July 2013 (Federal Law Gazette I p. 2420) which entered into
force on 1st August 2013,

25. Article 1 of the Ordinance of 12th July 2013 (Federal Law Gazette I p. 2439) which en-
tered into force on 19th April 2013,

26. Article 2 of the Law of 23rd July 2013 (Federal Law Gazette I p. 2565) which entered into
force on 1st September 2013,

27. Article 1 of the Law of 7th August 2013 (Federal Law Gazette I p. 3108) which entered
into force on 13th August 2013,

28. Article 2 (24) and Article 4 (11)* of the Law of 7th August 2013 (Federal Law Gazette I p.
3154) which entered into force on 15th August 2013,

29. Article 1 of the Law of 10th October 2013 (Federal Law Gazette I p. 3813) which entered
into force on 01st April 2014.

____________________

* Amendments to Article 4 (11) of the Act on Structural Reform of the Federal Law on Fees were not in-
cluded in this version for technical reasons. The amendments will enter into force on 14th August 2018.
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Medicinal Products Act
(The Drug Law)
(Arzneimittelgesetz – AMG)∗)

Summary of Contents

∗) This Act serves to incorporate:
- 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),
- 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),
- Directive 2001/20/EC of the European Parliament and of the Council of 4th April 2001 on the ap-
proximation 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 p. 34),
- Directive 2002/98/EC of the European Parliament and of the Council of 27th January 2003 setting
standards of quality and safety for the collection, testing, processing, storage and distribution of
human blood and blood components and amending Directive 2001/83/EC (OJ L 33, p. 30),
- Directive 2004/23/EC of the European Parliament and of the Council of 31st March 2004 on setting
standards of quality and safety for the donation, procurement, testing, processing, preservation,
storage and distribution of human tissues and cells (OJ L 102, p. 48),
- Directive 2004/24/EC of the European Parliament and of the Council of 31st March 2004 amending,
as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relat-
ing to medicinal products for human use (OJ L 136, p. 85),
- Directive 2004/27/EC of the European Parliament and of the Council of 31st March 2004 amending
Directive 2001/83/EC on the Community code relating to medicinal products for human use (OJ L
136, p. 34),
- Directive 2004/28/EC of the European Parliament and of the Council of 31st March 2004 amending
Directive 2001/82 on the Community code relating to veterinary medicinal products (OJ L 136, p.
58),
- Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amend-
ing, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medici-
nal products for human use (OJ L 348 of 31.12.2010, p. 74, L 2 of 25.1.2011, p. 8),
- Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Di-
rective 2001/83/EC on the Community code relating to medicinal products for human use, as regards
the prevention of the entry into the legal supply chain of falsified medicinal products (OJ L 174 of
1.7.2011, p. 74),
- Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the appli-
cation of patients’ rights in cross-border healthcare (OJ L 88 of 4.4.2011, p. 45),
- Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 amending
Directive 2001/83/EC as regards pharmacovigilance (OJ L 299 of 27.10.2012, p. 1).
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First Chapter
Purpose of the Act, definition of terms, scope

Section 1 Purpose of the Act
Section 2 The term ‘medicinal product’
Section 3 The term ‘substance’
Section 4 Definitions of additional terms
Section 4a Exceptions to the scope of the present Act
Section 4b Special provisions governing advanced therapy medicinal products

Second Chapter
Requirements on medicinal products

Section 5 Prohibition in respect of unsafe medicinal products
Section 6 Empowerment in respect of health protection
Section 6a Prohibitions regarding medicinal products for doping purposes
in sport, information obligations
Section 7 Radiopharmaceuticals and medicinal products treated with
ionizing radiation
Section 8 Prohibitions to prevent deception
Section 9 The party responsible for placing on the market
Section 10 Labelling
Section 11 Package leaflet
Section 11a Expert information
Section 12 Empowerment in respect of labelling, package leaflet and
package sizes

Third Chapter
Manufacture of medicinal products

Section 13 Manufacturing authorisation
Section 14 Decision on the manufacturing authorisation
Section 15 Expert knowledge
Section 16 Limitation of the manufacturing authorisation
Section 17 Deadlines for the granting of an authorisation
Section 18 Withdrawal, revocation, suspension
Section 19 Areas of responsibility
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Section 20 Obligations to notify
Section 20a Applicability to active substances and other substances
Section 20b Authorisation for the procurement of tissues and the pertinent
laboratory testing
Section 20c Authorisation for the processing, preservation, testing and
storage or the placing on the market of tissues or
preparations made from tissues
Section 20d Exception from the obligation to obtain an authorisation for
tissues and tissue preparations

Fourth Chapter
Marketing authorisation for medicinal products

Section 21 Obligation to obtain a marketing authorisation
Section 21a Authorisation of tissue preparations
Section 22 Marketing authorisation documents
Section 23 Particular documents required for medicinal products
intended for administration to animals
Section 24 Expertises
Section 24a Use of a previous applicant's documents
Section 24b Authorisation of a generic medicinal product, document protection
Section 24c Additional requests
Section 24d General right of use
Section 25 Decision on marketing authorisation
Section 25a Prior examination
Section 25b Mutual-recognition procedure and decentralised procedure
Section 25c Measures taken by the competent higher federal authority on
decisions or resolutions of the European Community or the
European Union
Section 26 Guidelines for the testing of medicinal products
Section 27 Deadlines for the granting of marketing authorisations
Section 28 Power to impose conditions
Section 29 Obligation to notify, renewal of the marketing authorisation
Section 30 Withdrawal, revocation, suspension
Section 31 Expiry, prolongation
Section 32 Official batch testing
Section 33 Fees and expenses
Section 34 Informing the public
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Section 35 Empowerments in respect of marketing authorisation
and exemptions
Section 36 Empowerment in respect of standard marketing authorisations
Section 37 Authorisation by the European Community or the European Union for
placing on the market, marketing authorisation of medicinal products
from other states

Fifth Chapter
Registration of medicinal products

Section 38 Registration of homeopathic medicinal products
Section 39 Decision on the registration of homeopathic medicinal products,
procedural provisions
Section 39a Registration of traditional herbal medicinal products
Section 39b Registration documents for traditional herbal medicinal products
Section 39c Decision on the registration of traditional herbal medicinal products
Section 39d Other procedural provisions for traditional herbal medicinal products

Sixth Chapter
Protection of human subjects in clinical trials

Section 40 General conditions for the clinical trial
Section 41 Special conditions for the clinical trial
Section 42 Ethics committee procedure, procedure for authorisation by the
higher federal authority
Section 42a Withdrawal, revocation and suspension of the authorisation
or of the favourable opinion
Section 42b Publication of the results of clinical trials

Seventh Chapter
Sale of medicinal products

Section 43 Pharmacy-only requirement, placing on the market by
veterinarians
Section 44 Exceptions to the pharmacy-only requirement
Section 45 Authority to allow further exceptions to pharmacy-only
requirement
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Section 46 Authority to extend the pharmacy-only requirement
Section 47 Distribution channel
Section 47a Special distribution channels, obligation to keep records
Section 47b Special distribution channels, diamorphine
Section 48 Prescription requirement
Section 49 (no longer applicable)
Section 50 Retail trading of over-the-counter medicinal products
Section 51 Sale by itinerant traders
Section 52 Prohibition of self-service
Section 52a Wholesale trading of medicinal products
Section 52b Supply of medicinal products
Section 52c Brokering of medicinal products
Section 53 Expert consultation

Eighth Chapter
Safety and quality control

Section 54 Internal regulations
Section 55 Pharmacopoeia
Section 55a Official compilation of test procedures

Ninth Chapter
Special provisions for medicinal products intended for use in animals

Section 56 Medicated feeding stuffs
Section 56a Prescription, dispensing and use of medicinal products by
veterinarians
Section 56b Exceptions
Section 57 Acquisition and possession by keepers of animals, records
Section 57a Use by animal keepers
Section 58 Use in food-producing animals
Section 58a Notifications about animal keeping
Section 58b Notifications about the use of medicinal products
Section 58c Determining the treatment frequency
Section 58d Reduction in treatment with antibacterially active substances
Section 58e Authority to issue ordinances
Section 58f Use of data
Section 58g Evaluation
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Section 59 Clinical trial and residue testing in food-producing animals
Section 59a Trade in substances and preparations from substances
Section 59b Substances for conducting residue tests
Section 59c Obligations to keep records of substances which can be
used as veterinary medicinal products
Section 59d Administration of pharmacologically active substances to
food-producing animals
Section 60 Pet animals
Section 61 Powers of veterinary schools

Tenth Chapter
Pharmacovigilance

Section 62 Organisation of the pharmacovigilance system of the
competent higher federal authority
Section 63 Graduated plan
Section 63a Graduated plan officer
Section 63b General pharmacovigilance obligations of the marketing
authorisation holder
Section 63c Documentation and reporting obligations of the holder of a
marketing authorisation for medicinal products for human use
in the case of suspected adverse reactions
Section 63d Periodic safety update reports
Section 63e European procedure
Section 63f General prerequisites for non-interventional post-authorisation
safety studies
Section 63g Special prerequisites for imposed non-interventional post-
authorisation studies
Section 63h Documentation and notification obligations for medicinal
products for animal use
Section 63i Documentation and notification obligations in respect of blood
and tissue preparations and tissues
Section 63j Exceptions

Eleventh Chapter
Supervision
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Section 64 Conducting supervision
Section 65 Sampling
Section 66 Obligation to tolerate and collaborate
Section 67 General notification requirement
Section 67a Database-supported information system
Section 68 Obligation to inform and to report
Section 69 Measures by the competent authorities
Section 69a The supervision of substances which can be used as
medicinal products for animals
Section 69b Use of specific data

Twelfth Chapter
Special provisions for the Federal Armed Forces,
Federal Police, Public Order Police, Civil Protection

Section 70 Application and enforcement of the Act
Section 71 Exceptions

Thirteenth Chapter
Import and export

Section 72 Import authorisation
Section 72a Certificates
Section 72b Import authorisation and certificates for tissues and
specific tissue preparations
Section 73 Prohibition of introduction
Section 73a Export
Section 74 Participation of customs offices

Fourteenth Chapter
Information Officer, Pharmaceutical Consultant

Section 74a Information Officer
Section 75 Expert knowledge
Section 76 Duties

Fifteenth Chapter