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preamble_24

Whereas it is necessary to provide for the orderly introduction of Community procedures for the authorization of medicinal products alongside the national procedures of the Member States which have already been extensively harmonized by Directives 65/65/EEC, 75/319/EEC and 81/851/EEC; whereas it is therefore appropriate in the first instance to limit the obligation to use the new Community procedure to certain medicinal products; whereas the scope of the Community procedures should be reviewed in the light of experience at the latest six years after the entry into force of this Regulation;

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.