In Belgium, businesses require an authorization to manufacture, import and/or distribute pharmaceuticals in the Belgian territory. In addition to this marketing authorization, each medicinal product intended to be marketed in Belgium must be properly registered. Both the marketing authorization and the registration are delivered by the Ministry of Public Health. The applicant must comply respectively with the procedures described in the Royal Decrees of June 6, 1960 and July 3, 1969, as modified. These procedures have been implemented in accordance with EU Directives.
Recently, in addition to the local registration systems of medicinal products in each EU Member State, the EU Council has enacted a Regulation organizing a centralized registration system at the European level.
This Regulation (Council Regulation 2309/93 of July 22, 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products) entered into effect on January 1, 1995 and is directly applicable in the Member States. The European Medicinal Evaluation Agency (EMEA) is based in the U.K., London E14 4HB, Westferry Circus 7, Canary Wharf. Its activities have effectively started on January 26, 1995.
The new centralized system is applicable to all medicinal products listed in the Annex attached to the Council Regulation (such as products developed by means of certain biotechnological processes). The system is compulsory for the medicinal products listed in Part A of this Annex. It may be freely selected for the products listed in Part B of this Annex, in lieu of the existing decentralized systems of the Member States.
The decentralized systems remain applicable for all medicinal products not listed in the above Annex as well as, at the applicant's option, for the products listed in Part B of this Annex.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
For further information contact Tanguy Van Overstraeten on +32.2.517.94.05.
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