Medicines law

Authors: Prof. Dr. med. Peter Altmeyer, Prof. Dr. med. Martina Bacharach-Buhles

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Last updated on: 29.10.2020

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Synonym(s)

AMG

Definition
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The German Medicines Act (AMG) is referred to as the Act on the Marketing of Medicinal Products in its latest version, dated 24 August 1976. It is a law of special administrative law and regulates, among other things, in 18 sections the marketing, manufacture, approval, distribution and quality control of medicinal products in the interest of the proper and safe supply of medicinal products to humans and animals. In addition, section 6 of the AMG regulates the "protection of humans during clinical trials". The following sections are listed in detail:
  1. Section: Purpose of the law and definitions, scope
  2. .section: Requirements for medicinal products
  3. Section: Manufacturing of medicinal products, placing on the market of tissues or tissue preparations
  4. Section: Marketing authorisation for medicinal products
  5. Section: Registration of medicinal products
  6. Section: Protection of human beings during clinical trials
  7. Section: Distribution of medicinal products
  8. Section: Quality assurance and control
  9. Section: Special provisions for medicinal products used in animals
  10. Section: Monitoring, collection and assessment of risks of medicinal products
  11. Section: Monitoring (implementation of monitoring, sampling, etc.)
  12. Section: Special provisions for the Bundeswehr, Federal Police, Riot Police, Civil Protection
  13. Section: Import and export
  14. Section: Information officer, pharmaceutical consultant
  15. Section: Determination of the competent higher federal authorities and other provisions
  16. Section: Liability for damage to medicinal products
  17. Section: Penalties and sanctions
  18. Section: Transitional and transitional provisions

Literature
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