Article 5 procedure: Regulatory and procedural guidance. See the full regulatory and procedural guidance index - Veterinary medicines. List item. European Medicines Agency procedural advice on recommendations on unforeseen variations according to Article 5 of Commission Regulation (EC) No 1234/2008 (PDF/79.26 KB)
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2020-7-1 · 5 The coordination group established under Article 27 of Directive 2001/83/EC (CMDh) has agreed to promote the use of zero-day mutual recognition procedure/repeat use procedure to expand national marketing authorisations to new Member States who need these medicinal products.
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