We are happy to announce a substantial revision to the course SUB06: Variations to Marketing Authorisations in Europe. The course is now fully up to date with the amendments to European Union law effected by Commission Delegated Regulation (EU) 2024/1701, which came into force in 2025. It is also up to date with the amendments proposed by the European Commission to its guideline on classification of variations and on procedures for submission and review of variations notifications and applications. 

The holder of an authorisation to market a medicinal product may wish to change the terms of the authorisation – for example, to allow the holder to adjust the composition of the product, alter its manufacturing process, or enable it to be used in a different way. In the European Economic Area, such changes are called variations, and the marketing authorisation holder is required to submit to the relevant regulatory authorities a notification of the changes or an application for permission to make them.

This course provides a detailed account of the requirements for variations notifications and applications in accordance with the latest versions of the relevant legal statute and regulatory guidance applying to products for human use. We define variations and distinguish their various types. We describe the procedures and documentation required for each type, both in general for all submissions and specifically for those in the Centralised Procedure and in the Mutual Recognition Procedure or purely national procedures.