Medicines Act (Germany)

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Basic data
Title: Law on the Marketing of Medicinal Products
Short title: Medicines Act
Abbreviation: AMG
Type: Federal law
Scope: Federal Republic of Germany
Legal matter: Special administrative law , pharmaceutical law
References : 2121-51-1-2
Original version from: May 16, 1961
( BGBl. I p. 533 )
Entry into force on: predominantly August 1, 1961
New announcement from: December 12, 2005
( BGBl. I p. 3394 )
Last revision from: August 24, 1976
( Federal Law Gazette I pp. 2445, 2448 )
Entry into force of the
new version on: 		January 1, 1978
Last change by: Art. 2 G of June 25, 2020
( Federal Law Gazette I p. 1474, 1476 )
Effective date of the
last change: 		June 30, 2020
(Art. 5 G of June 25, 2020)
GESTA : C123
Weblink: Text of the law
Please note the note on the applicable legal version.

The German Medicines Act (AMG) is a law of special administrative law and regulates the trade in medicinal products in the interest of a proper and safe supply of medicinal products to humans and animals. In terms of content, it is close (supplementary) to the Narcotics Act and the New Psychoactive Substances Act . The current version of the Medicines Act (in accordance with the 1976 Act) largely replaced the Medicines Act from 1961; However, Section 99 AMG still refers to this law.

content

The Medicines Act of 1976 applies to human and veterinary medicinal products and consists of 18 sections. Among others, the following are important:

  • Definition of the term “medicinal product” and other definitions
  • Requirements for the pharmaceuticals
  • Manufacture of medicines
  • Authorization and registration of finished medicinal products
  • Dispensing of medicines
  • Protection of humans during clinical trials
  • Quality assurance and control
  • Monitoring, collecting and evaluating drug risks
  • monitoring
  • Liability for drug damage

The Medicines Act serves as the legal basis for the protection of the health of the population, in particular due to the high demands on the care in handling medicines by the pharmaceutical industry, pharmacists and doctors. This applies above all to the issues of manufacturing, placing on the market , testing, prescribing, providing information on and dispensing of drugs. Violations of the AMG are sometimes punished as administrative offenses and sometimes as criminal offenses (see §§ 95 ff. ). It is therefore part of ancillary criminal law .

Newer aspects, in particular the importance of certain preparations in sports ( " doping "), carrying the law into account by the use of doping substances ( § 6a ) mounted on a by the interior ministry to be adopted ordinance is prohibited based list, punishable (§ 95).

In Sections 84 et seq. , The Medicines Act also regulates the responsibility for damage to medicinal products, which is designed as strict liability and since the amendment by the Damages Act Amendment Act of 2002 provides for particular easing of evidence for the causal relationship.

In implementing European regulations (see also Directive 2001/83 / EC ), the AMG enables a simplified registration procedure for certain homeopathic medicinal products and for traditional herbal medicinal products . In this only the quality and safety of the drug, but not the medical effectiveness, are to be proven.

The Medicines Act does not deal with social law issues (reimbursement eligibility) or economic interests of the pharmaceutical industry.

history

Until 1961 there was no separate drug law in Germany, but parts of the drug law were regulated by various provisions that were distributed in a large number of laws and ordinances. In 1928, 1931, 1933 and 1938 the first drafts for a drug law were made, but they were not implemented.

Medicines Act of 1961

The Treaty of Rome for the approximation of European legal provisions called for a national pharmaceutical law, which Germany was the only member of the European Economic Community (EEC) to not have. Therefore, on November 14, 1961, the federal government established a health ministry as the last EEC country . Elisabeth Schwarzhaupt (CDU) became the first Minister of Health .

The AMG of 1961 contained no obligation to test the effectiveness and safety of the drugs, but only provided for registration. The medication should not be tested by the Federal Health Office, but if substances are used whose effectiveness is not “generally known”, a report on the type and extent of any side effects found should be enclosed. This should avoid delays in registration in order to keep German companies competitive in international competition. The manufacturer should also be responsible for effectiveness. Only “medical examinations”, but not clinical examinations for new drugs, were required. In 1964, § 21 was supplemented by two paragraphs 1a and 1b, which prescribed the testing of drugs through preclinical and clinical studies. From then on, the manufacturers had to provide a meaningful written assurance that the drug had been adequately and carefully checked in accordance with the current state of scientific knowledge.

On July 11, 1971, Federal Minister of Health Käte Strobel announced the directive on the testing of medicinal products . The principles for the pharmacological-toxicological and clinical testing of medicinal products were laid down in it. The Federal Health Office was instructed to only register drugs that have been tested in accordance with the directive.

New version from 1976

Since the thalidomide -Vorfällen that were known as of November 1961 demands were for an improvement of drug safety louder. The Drugs Act of February 8, 1961, which had just been passed, was changed a total of 17 times by 1971, but a fundamental reform and thus a new overall concept were necessary. At the level of the European Community, a guideline for the requirements for the approval of medicinal products had already been laid down in 1965, the implementation of which in German law represented a first step in the creation of a European internal market for medicinal products.

On July 17, 1974, the draft law to reorganize pharmaceutical law was unanimously approved by the federal cabinet. On October 18, 1974, the Federal Council issued an initial opinion on this in accordance with the legislative procedure . At the beginning of January 1975, the Federal Government approved most of the Federal Council's suggestions for improvement in its counter-statement , some it approved in a modified version, and still others it only took note of it.

Core content

The new law has the following core content.

  • Establishment of an approval procedure with proof of quality, effectiveness and harmlessness.
  • The term “medicinal specialty” is replaced by “finished medicinal product”, defined as a medicinal product that has been manufactured in advance and placed on the market in a package intended for delivery to the consumer. The generics that were previously not even subject to registration are on an equal footing with the finished medicinal products formerly known as "medicinal specialties" and therefore also require authorization.
  • The less strict registration procedure will be retained for homeopathic medicinal products that do not state any effects or areas of application.
  • Extensive requirements are placed on the package insert and the labeling on the drug packaging .
  • The requirements for the prerequisite for granting manufacturing authorization are stricter; The operating site must have suitable rooms and equipment ( good manufacturing practice , GMP) and certain personal responsibilities are required.
  • The drug trade (distribution, dispensing) is more strictly regulated and monitored.
  • Establishment of an information system to collect and evaluate drug risks and to take countermeasures ( step-by-step plan procedure ).
  • A strict liability of the pharmaceutical entrepreneur regardless of fault. To do this, he must take out liability insurance so that possible claims for damages that may arise from damage caused by drugs are covered.
  • Since a clinical proof of efficacy is required for finished medicinal products, the law contains protective provisions for test subjects and patients who take part in the corresponding clinical trials. For example, the pharmaceutical company must take out volunteer insurance.

Special therapy directions

The drug law grants approval only drugs of homeopathy , of anthroposophic medicine and phytotherapy ( "special treatment directions") special privileges one: such a license are in the decision to grant or extension of the ' medical experiences "or" the specifics "of this therapy directions to be taken into account (so-called internal consensus ). Approvals may not be denied without the participation of appropriate commissions specially set up by the approval authority. These national peculiarities are based on the "scientific pluralism" to which the legislature professed to avoid the "monopoly of a dominant teaching as a binding" state of scientific knowledge "" and led to criticism of the Medicines Act.

Post-registration

Finished medicinal products that were already on the market before 1978 were considered "fictitiously approved" when the new law came into force, in order to remain marketable. They were legally equivalent to the approved drugs with the condition that they had to undergo the new approval procedure within a transitional period of twelve years (reauthorization). Although AMG amendments made it easier for reauthorisation to be carried out, processing was slow and resulted in a large number of reauthorisation applications still not being completed in 1997 and the corresponding funds on the market without any proof of quality, effectiveness or harmlessness. The EU Commission therefore initiated infringement proceedings against the Federal Republic of Germany, which had failed to meet the implementation deadlines and had also made reauthorisation decisions that were not in accordance with EU law. The generous extension of the “fictitious approval” up to the end of 2004 had to be canceled, and the documentation requirement was tightened for applications for subsequent approval that had not yet been completed. The federal government undertook to complete the processing of the reauthorisation applications for the old products affected by the EU Commission's decree of October 21, 1998 by the end of 2005. Although the competent authority approved the applications in due time, there are still some fictitiously approved drugs on the market (as of February 2015) due to ongoing processing of conditions and legal proceedings.

AMG novellas

So far, the law of 1976 has been amended several times. Essentially, these were changes that were made necessary by the harmonization of pharmaceutical law in the European Union. In addition, there were amendments in order to be able to process the increased number of proceedings (approval backlog, post-approval) more quickly and to improve the law, for example when regulations had not proven their worth. A comprehensive amendment came into force on October 26, 2012. The focus is on the areas of pharmacovigilance and protection against counterfeit drugs .

On September 19, 2012, the Federal Cabinet passed a further amendment to the Medicines Act. In particular, the monitoring authorities should be able to assess the frequency of treatment with antibiotics in livestock farms and to use this to keep a nationwide database.

Market access

Market access for pharmaceuticals from EU member states was created with the 7th Amendment to the AMG (1998) by including additional procedures in the Medicines Act. In line with European regulations, drugs are now marketable in Germany not only through a purely national authorization but also through an "EU authorization" (see centralized authorization procedure ). Furthermore, the German authorization authorities can use the mutual recognition procedure to do so beforehand in another EU country accept nationally issued approval for their own market. In 2005, with the 14th amendment, the decentralized approval procedure for obtaining a marketing license was added. The pharmaceutical company no longer has to apply for a license extension every 5 years, as before, but usually only once again after 5 years, after which the approval is valid indefinitely. Approval for drugs that are not marketed expires after 3 years. The registration procedure for homeopathic medicinal products was harmonized by the 5th amendment (1994) and 14th amendment (2005) through the implementation of European directives, with the 14th amendment a registration procedure for traditionally used herbal medicinal products was added.

With the 14th amendment to the AMG, the exceptional placing on the market of unauthorized finished medicinal products for humanitarian reasons ( compassionate use ) became legally permissible, as they were expressly excluded from the authorization requirement.

Clinical trial

With the 2nd amendment to the AMG (1986), the clinical test was made subject to official supervision: in addition to the pharmacological-toxicological documents for the medicinal product, the pharmaceutical company also had to submit a test plan for the clinical study to the licensing authorities . The 12th Amendment to the AMG (2004) brought about a comprehensive new regulation with the implementation of a large number of European directives on good clinical practice : the obligation to notify the licensing authorities was replaced by an approval procedure and an authorization to issue ordinances , which introduced extensive provisions in the form of the ordinance on application of Good Clinical Practice in the implementation of clinical trials with medicinal products for use in humans ( GCP regulation ) made legally binding. For example, in addition to the documents that have to be submitted so far, a dossier on the pharmaceutical quality of the investigational product , a so-called Investigational Medicinal Product Dossier (IMPD), must be submitted with the application for approval. The approval processes of the ethics committees and the approval authorities have been decoupled. An electronic and standardized format has been stipulated for reporting suspected cases of unexpected serious side effects to the competent German higher federal authority or the competent higher authorities of other EU member states and the ethics committees. Since the 12th amendment to the AMG, documents about a clinical trial on children or adolescents have to be submitted with the application for approval if a drug is to be approved for them. Previously, the results of clinical trials in adults were simply transferred to children.

Pharmacovigilance

Under Pharmacovigilance is defined as the ongoing systematic monitoring of drug safety in the sense of collecting and analyzing adverse drug reactions to be able to seize any measures necessary to minimize risks. The first version of the new Medicines Act obliged the German licensing authorities to centrally record drug risks and, if necessary, to initiate appropriate countermeasures using the so-called phased plan procedure. With the 2nd amendment to the AMG (1986), the function of the phased plan officer was created: a pharmaceutical company must entrust a suitably qualified person with the coordination of the observation, collection and evaluation of drug risks and the necessary cooperation with the authorities. In 2004, the 12th amendment to the AMG expanded the pharmacovigilance regulations by adapting them to European law: the pharmaceutical company was obliged to document and report suspected side effects. Suspected serious side effects of drugs must be electronically transmitted in a standardized format to the competent higher German federal authority within certain deadlines, which is used to feed into a central database at the European Medicines Agency ( EudraVigilance ). The pharmaceutical company must also submit regularly updated reports on the safety of the medicinal product to the competent authority at specified intervals. Regulations for the detailed description of a pharmacovigilance and risk management system as well as the use of an internationally standardized medical terminology ( MedDRA ) for the transmission of side effect reports were innovations introduced by the 14th amendment to the AMG (2005).

In 2012, the Second Act to Change Pharmaceutical Law and other regulations implemented comprehensive changes resulting from the EU pharmaceutical package (“Pharmacovigilance Directive ”) with the aim of identifying drug risks more quickly and better and implementing the necessary measures quickly.

Veterinary drugs

The safety of veterinary medicinal products was improved by the 1st amendment (1983), 11th amendment (2002) and 13th amendment (2005). The Medicines Act contains special regulations for veterinary medicinal products, for example for the prescription, dispensing and use by veterinarians , as well as for feed medicinal products and especially for the use of medicinal products in animals that are used to obtain food ( waiting time , residue check ).

Regulation of application processing

After the new AMG came into force, the capacities of the licensing authority were not able to cope with the number of applications; In addition to the applications for authorization for new drugs, there were also applications for generics and a large number of applications for subsequent authorization for old drugs. By including external counter- experts in the processing of the application (3rd AMG amendment, 1988), the temporal equalization of the reauthorisation procedure and the simplification of the amendment law for old medicinal products (4th AMG amendment, 1990), the processing should be accelerated. Nevertheless, just four years later, with the 5th amendment to the AMG (1994), new measures to accelerate reauthorisation were introduced: the generous right to amend, which created more official work than avoided, was revised again. The preparation work of the approval commissions was discontinued and instead the burden of proof for the effectiveness and harmlessness of a drug was completely transferred to the applicant. In the reauthorisation procedure, the remedial period for applicants was shortened and the legal remedies against reauthorisation decisions were curtailed. Easier conditions for re-registration have been created for traditionally used drugs. Pharmaceutical companies who agreed to withdraw their reauthorisation application by a deadline were granted a sale until the end of 2004. After the EU Commission had criticized in 1998 that some of the measures introduced did not comply with EU law, they were abolished again with the 10th AMG Amendment (2000), and in return the deadline for remedying defects was further shortened. Also due to the 10th amendment to the AMG, fictitious medicinal products (old medicinal products) had to be labeled as such ( "This medicinal product is on the market in accordance with the transitional statutory provisions. The official examination of pharmaceutical quality, efficacy and safety has not yet been completed." )

Other innovations
  • The 2nd amendment (1986) introduced the specification of an open expiry date and the specialist information .
  • The pharmacopoeia became official with the 5th amendment to the AMG (1994) .
  • In the 7th Amendment to the AMG (1998), for the first time, there are direct references to European legal provisions, which thereby become legally valid at national level without this requiring implementation.
  • The 9th amendment (1999) served to set up a special distribution channel for drugs used to carry out an abortion .
  • The mail order business with pharmacy-only pharmaceuticals was given a legal basis with the 12th AMG amendment (2004) by converting the general prohibition from the 8th AMG amendment (1998) into a prohibition subject to authorization .
  • The drug name must be embossed in Braille ("Braille") on drug packs (12th AMG-Novelle, 2004).
  • Counterfeit drugs are threatened with higher penalties (12th AMG amendment, 2004).
  • The 14th amendment to the AMG (2005) introduced exceptions in the event of a pandemic . It also reorganized the prescription requirement . The automatic prescription requirement for new substances was eliminated, as was the automatic release from the prescription requirement after the deadline. As a result of the amendment, the prescription requirement is to be regulated in an ordinance, and medicinal substances must be actively made subject to prescription by the legislator or released from it.

Statutory ordinances based on an authorization in the AMG

The Medicines Act contains numerous statutory authorizations and is therefore the legal basis for many different statutory ordinances (selection):

literature

  • Erwin Deutsch / Hans-Dieter Lippert (Ed.): Commentary on the Medicines Act (AMG) , 3rd edition, Heidelberg 2010, Springer-Verlag, ISBN 978-3-642-01454-3
  • Horst Hasskarl and Hellmuth Kleinsorge: drug testing, drug law. National and international regulations and recommendations . 2nd edition, Stuttgart 1979. Gustav Fischer Verlag, ISBN 3-437-10562-0
  • Kloesel / Cyran: Drug Law - Commentary with official justifications, further materials and relevant legal provisions as well as a collection of court decisions , justified by A. Kloesel and Walter Cyran , continued by K. Feiden and HJ Pabel. 3rd edition including 106th update delivery, 2007. ISBN 978-3-7692-4466-3
  • Kügel / Müller / Hofmann: AMG. Commentary , 1st edition, Munich 2012, Verlag CH Beck, ISBN 978-3-406-61457-6

Web links

Individual evidence

  1. ↑ a b c Helga Blasius: 25 Years of the Medicines Act. The basis of our drug safety. In: Deutsche Apotheker-Zeitung , issue 41, 2003.
  2. ^ The long road to the drug law in Germany: Hundred years of loophole. ( Memento from February 28, 2011 in the Internet Archive ) WDR, November 24, 2006.
  3. ↑ Directive 65/65 / EEC (PDF) of the Council of January 26, 1965 on the harmonization of legal and administrative regulations on medicinal specialties
  4. ^ Herbert Hügel , Jürgen Fischer, Baldur Kohm: Pharmaceutical Law: Text collection with explanations for study and practice. 30th edition, Deutscher Apotheker Verlag, Stuttgart 1995
  5. ↑ Barbara Burkhard: Anthroposophic Medicines. A critical consideration. GOVI, Eschborn 2000, p. 10.
  6. ↑ Bundestag Committee for Youth, Family and Health. Preamble in preparation of the 2nd AMG of August 24, 1976. Bundestag printed paper 7/5091, page 7 (PDF; 838 kB)
  7. ↑ I. Oepen, Marburg: From the perspective of scientific medicine - shortcomings in case law ( Memento of September 21, 2013 in the Internet Archive ), ( PDF file, 322 K B ; 329 kB). Presentation at the meeting of the “Doctors and Jurists” working group in November 1999 in Berlin. Retrieved February 24, 2012
  8. ↑ BfArM: Fictitious authorization , accessed May 5, 2015.
  9. ↑ Recourse for fictitiously approved drugs. arznei-telegramme.de, April 5, 2012.
  10. ↑ Fictitious approved drugs. ( Memento from May 5, 2015 in the Internet Archive ) Mecklenburg-Western Pomerania Association of Statutory Health Insurance Physicians, February 2015.
  11. ^ First law amending the Medicines Act of February 24, 1983 / BGBl. I, p. 169.
    Second law amending the Drugs Act of 16 August 1986 / BGBl. I, p. 1296.
    Third law amending the Medicines Act of July 20, 1988 / BGBl. I, p. 1050.
    Fourth law amending the Medicines Act of April 11, 1990 / BGBl. I, p. 717.
    Fifth law amending the Medicines Act of 9 August 1994 / BGBl. I, p. 2071.
    Sixth law amending the Drugs Act of December 20, 1996 / BGBl. I, p. 2084.
    Seventh law amending the Medicines Act of February 25, 1998 / BGBl. I, p. 374.
    Eighth law amending the Drugs Act of 7 September 1998 / BGBl. I, p. 2649.
    Ninth law amending the Medicines Act of July 26, 1999 / BGBl. I, p. 1666.
    Tenth law amending the Medicines Act of July 4, 2000 / BGBl. I, p. 1002.
    Eleventh law amending the Medicines Act of August 21, 2002 / BGBl. I, p. 3348.
    Twelfth law amending the Medicines Act of July 30, 2004 / BGBl. I, p. 2031.
    Thirteenth law amending the Medicines Act of 29 August 2005 / BGBl. I, p. 2555.
    Fourteenth law amending the Medicines Act of 29 August 2005 / BGBl. I, p. 2570.
    and all other changes since 2006
  12. ↑ Press release No. 258 of the BMELV of September 19, 2012: Stricter controls, stricter requirements, more transparency: the use of antibiotics in animal husbandry is to be significantly reduced ( Memento of November 29, 2012 in the Internet Archive ) .
  13. ↑ Federal Institute for Drugs and Medical Devices, Compassionate Use ( Memento from April 29, 2015 in the Internet Archive )
  14. ↑ 14. AMG amendment entered into force . Pharmaceutical newspaper , issue 36, 2005.
  15. ↑ Federal Institute for Drugs and Medical Devices, New Ordinance on Prescription Requirements ( Memento of August 9, 2009 in the Internet Archive ) created on June 6, 2006, updated on March 2, 2011.
  16. ^ Ordinances on the Medicines Act