Variations

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

Best practice guide for Type IA variations
updated November 2017, clean

Best practice guide for Type IA variations
updated November 2017, track changes

Best practice guide for Type IB variations

Best practice guide for Type II variations

Best practice guide for Type II variations
track changes

Best practice guide for grouping of variations updated December 2018

Best practice guide for grouping of variations updated December 2018 with track changes

Best practice guide for worksharing
Updated October 2017

Best practice guide for worksharing
Updated October 2017 with track changes

Worksharing procedural update

Worksharing - applicant's letter of intent

Template for Active Substance Master File (ASMF) Type IB variation assessment report

Recommendations for classification of unforeseen variations
according to Article 5 of Commission Regulation (EC) 1234/2008

Veterinary applications

Human applications

Best practice guide for the classification of unforeseen variations - Article 5

Article 5 recommendation - Request form

Questions and answers

CMDh-CMDv Q&A List for the submission of variations according to Commission Regulation (EC) 1234/2008

CMDh-CMDv Examples of acceptible and non-acceptible groupings for MRP-DCP

European Commission procedural and classification guidance on variations