Medicines law

Author: Prof. Dr. med. Peter Altmeyer

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Last updated on: 29.10.2020

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The German Medicines Act (Arzneimittelgesetz, or AMG for short) is known as the law "on the marketing of medicinal products". The AMG is a law of special administrative law and regulates, among other things, in 18 sections the marketing, manufacture, approval, supply and quality control of medicinal products in the interest of the proper and safe supply of medicinal products to humans and animals. In particular, it defines the concept of medicinal products and sets binding requirements for the approval of medicinal products.

Furthermore, the AMG regulates in its 6th section the "protection of humans during clinical trials". The following sections are listed in detail:

  1. Section: Purpose of the law and definitions, scope of application
  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

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Last updated on: 29.10.2020