[Revision of the Renewals Procedure and the implementation of the sunset clause. BfArM’s experience
June 29th, 2008 | by admin |[Revision of the Renewals Procedure and the implementation of the sunset clause. BfArM\’s experience with the amended legislation.]
Two years after the 14(th) Amendment of the German Medicines Act came into force, including the changes involved in the renewals procedure, most but by far not all questions have been answered. This also applies to the procedure for the sunset clause, whereby marketing authorisation will expire because the medicines were not marketed for three successive years. For renewals, a reduction in workload for both the industry and the higher federal authority has been achieved, due to the decline in the number of renewal applications. Contrary to this, 2008 will be a very intense year for the sunset clause. For the first time in September 2008, according to section 31 sub-section 1 sentence 1 of the Medicinal Products Act, the three year time limit comes into effect. This means that about 7000 marketing authorisations will be threatened with expiration.
Horn M.
Bundesinstitut für Arzneimittel und Medizinprodukte, Bonn, BRD, m.horn@bfarm.de.