Renewed authorisation

When the German Medicines Law (AMG) came into force in 1978, 126,000 drugs were disclosed on the market was (disclosure was compulsory until 30 June 1978). A review of these preparations was planned according to the requirements of the AMG, in terms of quality, efficacy and safety. To do this, the drug manufacturer had to submit a request with the appropriate documentation within 12 years. This process is called renewed authorisation. 32,054 specimens were registered for renewed authorisation by the due date (30/04/1990). Of these there were 6,700 finished medicinal herbal ingredients. The renewed authorisation finally ended at the end of 2005 with the 14th amendment to the AMG, which finally settled authorisations (¤ 21 AMG) and registration (¤ 39a) again of herbal medicines by implementing the relevant EU directives (1999/83/EC and 2004/24/EC).