Synonym(s)
AMG
DefinitionThis section has been translated automatically.
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:
- Section: Purpose of the law and definitions, scope
- .section: Requirements for medicinal products
- Section: Manufacturing of medicinal products, placing on the market of tissues or tissue preparations
- Section: Marketing authorisation for medicinal products
- Section: Registration of medicinal products
- Section: Protection of human beings during clinical trials
- Section: Distribution of medicinal products
- Section: Quality assurance and control
- Section: Special provisions for medicinal products used in animals
- Section: Monitoring, collection and assessment of risks of medicinal products
- Section: Monitoring (implementation of monitoring, sampling, etc.)
- Section: Special provisions for the Bundeswehr, Federal Police, Riot Police, Civil Protection
- Section: Import and export
- Section: Information officer, pharmaceutical consultant
- Section: Determination of the competent higher federal authorities and other provisions
- Section: Liability for damage to medicinal products
- Section: Penalties and sanctions
- Section: Transitional and transitional provisions