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ARTICLE · 01 FEBRUARY 1995

EU Centralized Registration for Medicinal Products

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BelgiumEnvironment
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.

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