Variations

Guidance documents on Variations - Regulation (EU) 2019/6

Variations not requiring assessment (VNRA)

Commission Implementing Regulation (EU) 2021/17 of 8 January 2021 establishing a list of variations not requiring assessment in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council

Best Practice Guide for variations not requiring assessment

Letter of intent for submission of VNRA supergrouping

Variations requiring assessment (VRA)

Guidance on the details of the classification of variations requiring assessment according to Article 62 of Regulation (EU) 2019/6 for veterinary medicinal products and on the documentation to be submitted pursuant to those variations

Best Practice Guide for variations requiring assessment

Guidance on the submission of G.I.18 Variations Requiring Assessment

Not already listed variations

Procedural advice for requests for the classification of variations not already listed in Commission Implementing Regulation (EU) 2021/17 or EMA/CMDv guidance on the details of the classification of variations requiring assessment according to Article 62

Request form - Request for a recommendation on the classification of a not already listed variation

Worksharings

Best Practice Guide for work-sharing

Letter of Intent

Public assessment report

For the “Best Practice guide for Production and Publication of Public Assessment Reports”, please refer to the section Authorisation Procedures

Questions and answers

Q&A - List for the submission of variations according to Regulation (EU) 2019/6

CMDh-CMDv Q&A – List for QP declaration