Medicinal Products Act (AMG)

Medicinal Products Act (AMG) – German Drug Law Arzneimittelgesetz (AMG)
Germany and Austria both have laws regulating the trade of medicinal products. The primary objective of the legislators when enacting these laws is to ensure that only medicinal products that have been proven to be harmless and safe and of a certain quality were put on the market. Furthermore, the laws regulate areas such as the manufacturing, authorization, prescription requirement, surveillance of medicinal products, pharmacovigilance and warranty in case of adverse drug reactions.

The German Medicinal Products Act (AMG) was published on 16 May 1961. Since then, it has been amended several times, for example, to incorporate directives of the European Community into national law. Currently, the 16th amendment of the AMG, comprising 18 sections, is in force.

The (AMG) was published on 02 March 1983. It has also been amended several times and consists of 14 sections.

The Swiss law corresponding to the AMG is called Therapeutic Products Act (TPA – Federal Act on Medicinal Products and Medical Devices) which was enacted on 15 December 2000. While the German and Austrian laws only deal with medicinal products, the Swiss law also contains provisions for medical devices. Germany and Austria both have separate laws regulating medical devices.

Where clinical research is concerned or when it comes to the safety of medicinal products, several international regulations must be considered: the Declaration of Helsinki of the WHO, ICH-GCPEU Directive 2001/20/EC and EU Regulation 536/2014 which will soon become effective. Important texts dealing with medical devices are ISO 14155 and EU Regulation 2017/745 (MDR).

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