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S.L. 458.35 · Pharmacovigilance Regulations (S.L. 458.35)

S.L. 458.35 ст. 52Decision on measures relating to marketing authorisations.

Title II of Regulation (EC) No 726/2004;

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Article 10 of Regulation (EC) No 726/2004 shall apply to the decision referred to in regulation 51(1)( ). Where the b

Commission adopts such decision, it may also adopt a decision addressed to the Member States pursuant to Article 127a of Directive 2001/83/EC as amended.