Variations

Best Practice Guides - Commission Regulation (EC) No 1234/2008

Type II variations – clean version, updated February 2017

Type II variations – track change version, updated February 2017

 

Recommendations for classification of unforeseen variations according to article 5 of Commission Regulation (EC) 1234/2008, click below:

Veterinary applications - Updated January 2015

Human applications

Article 5: Request Form

Questions and answers

CMDh-CMDv Q&A list for the submission of variations according to Commission Regulation (EC) 1234/2008 (May 2017), click here

Link to the European Commission procedural and classification guidance on variations (link) UPDATED MAY 2013