By A. C. Cartwright
Presents a scientific account of the foremost technical, administrative and criminal requisites for registering a product in any of the nationwide markets in the EEC, utilizing the present systems, with information as to how those approaches are inclined to switch after 1992.
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Extra info for Pharmaceutical Product Licensing: Requirements For Europe (Ellis Horwood Books in the Biological Sciences)
Volume I is the text of the Directives. For convenience these have been collated so that the texts of the later amendments replaces the original texts. An unofficial Addendum has been published in October 1989 containing the texts of the socalled ‘extension Directives’. These are described in Chapter 21. This five-volume set of texts forms part of the essential library for the researcher, the research and development pharmacist, the toxicologist, the pharmacologist, and the clinician engaged in organising clinical trials.
In other EC Member States (such as the UK) the registration committees (such as the CSM) are advisory, although in practice their advice is very seldom disregarded. In the Federal Republic of Germany the first German Drug Law of 1961 (AMG 1961) set up the Federal Health Office (Bundesgesundhheitsamt), made manufacture of products approvable by the authorities in the Länder (local authorities), and made registration of proprietary products obligatory. SchmittRau (1988) summarised the changes made by the Drug Law of 1976.
Any new medicinal product (such as the Massengill sulfanilamide elixir) could not be marketed until the FDA approved it as safe. 4 Thalidomide In 1946, the West German soap and cosmetic company of Dalli-Werke, Mäurer, and Wirtz formed a new pharmaceutical subsidiary named Chemie Grünenthal. In 1956 Grünenthal test marketed a combination product called Grippex containing thalidomide in Hamburg. This product was indicated for the treatment of respiratory infections. In 1957 thalidomide tablets were marketed in West Germany under the trade mark Contergan.