Article 5 procedure: Regulatory and procedural guidance
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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)
Adopted
First published: 27/03/2009
Last updated: 27/03/2009
EMEA/588416/2008 -
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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 (DOC/48 KB)
First published: 01/03/2009
Last updated: 29/08/2013