Regulatory & Procedural Guidelines
Regulatory and procedural guidelines (human and veterinary)
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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
European Medicines Agency procedural advice on recommendations on unforeseen variations according to Article 5 of Commission Regulation (EC) No 1234/2008 -
List of centrally authorised products requiring a notification of a change for update of annexes
List of centrally authorised products requiring a notification of a change for update of annexes -
IRIS guide to registration and RPIs
IRIS guide to registration and RPIs -
EU Implementation Guide (IG) on veterinary medicines product data - Chapter 2: Format for the electronic submission of veterinary medicinal product information
EU Implementation Guide (IG) on veterinary medicines product data - Chapter 2: Format for the electronic submission of veterinary medicinal product information -
Good practices for industry for the prevention of human medicinal product shortages
Good practices for industry for the prevention of human medicinal product shortages