Objectives and achievements of medicines regulations in the BENELUX countries
Experience gained by the BENELUX authorities during the establishment of a common registration process for medicines intended for human use, is presented.
The BENELUX department for registration of medicines was established in 1972.
3. During the first five years of operation, few submissions were presented as industry continued to prefer the national registration procedure.
In 1978 the department was reorganized and the choice between the national procedure and the BENELUX procedure was abolished. However, the resulting increase in the number of submissions meant only a fraction could be handled by the experts and the agreed delays for issuing an opinion were hard to respect.
The department was dismantled in December 1982 partly for economic reasons and because progress within the EEC meant the reasons for establishing the department no longer applied. However, the experience gained should be considered in future EEC decisions.
KeywordsMedicine Regulation Marketing Authorization Mutual Recognition Registration Request Free Circulation
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