Article 5 procedure: Regulatory and procedural guidance

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See the full regulatory and procedural guidance index - Veterinary medicines

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Document(s) Language Status First published Last updated Effective Date
European Medicines Agency procedural advice on recommendations on unforeseen variations according to Article 5 of Commission Regulation (EC) No 1234/2008 (English only) adopted 2009-03-27    
Request to CMDh / CMDv / European Medicines Agency for a recommendation on the classification of an unforeseen variation under Article 5 of Commission Regulation (EC) No 1234/2008 (English only)   2009-03-01 2013-08-29