Follow-up Procedures

Variations to the Terms of a Marketing Authorisation

If variations to an authorisation, i.e. changes to the terms of a marketing authorisation, are planned resulting in changes to the documents submitted for the application for authorisation, those changes must be reported to the authority responsible for the authorisation. Depending on how significant these changes are, they are subject to the consent, i.e. the approval, from the licensing authority.

For national authorisations (including authorisations granted in the mutual recognition procedure or in the decentralised procedure) and centralised authorisations, pursuant to Articles 61 and 62 of Regulation (EU) 2019/6, a distinction is made between:

• Variations Not Requiring Assessment (VNRA) and
• Variations Requiring Assessment (VRA).

In addition, Regulation (EU) 2019/6 also allows:

• submitting applications for grouped variations (groupings) and
• submitting applications for variations in the so-called worksharing procedure (worksharings).

A list of changes to the terms of a marketing authorisation falling into category VNRA is included in Commission Implementing Regulation (EU) 2021/17. These changes are directly recorded in the Union Product Database (UPD) by the marketing authorisation holder.

Changes to the terms of a marketing authorisation that fall into category VRA are applied for electronically by the marketing authorisation holder together with the necessary documents.

Further information, provisions and guidelines regarding variations to the terms of a marketing authorisation can be found on the websites of the European Medicines Agency (EMA) and the Coordination Group for Mutual Recognition and Decentralised Procedures for Veterinary Medicinal Products (CMDv).

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