Variations

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

Best practice guide for Type IA variations [Track version] (December 2020)

Best practice guide for Type IB variations [Track version] (December 2020)

Best practice guide for Type II variations [Track version] (December 2020)

Best practice guide for grouping of variations

Best practice guide for worksharing

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