Variation of the marketing authorisation

A variation of the marketing authorisation is any change made to the terms of an authorisation after its grant, whether it affects manufacture, controls, indications, posology or product information. The regime is laid down by Commission Regulation (EC) No 1234/2008, which applies to centralised authorisations, to authorisations resulting from the mutual recognition and decentralised procedures and, since its extension, to purely national authorisations. The holder may develop its product only by following the procedure corresponding to the category of the variation.

Classification of variations

• A Type IA minor variation requires only a notification, in principle within twelve months of its implementation, although some must be notified immediately.
• A Type IB minor variation must be notified before implementation, the holder waiting 30 days without objection from the authority.
• A Type II major variation, which may have a significant impact on quality, safety or efficacy, requires prior approval following an assessment.
• An extension, which concerns in particular the strength, the pharmaceutical form, the route of administration or certain aspects of the active substance, is examined under a procedure similar to that of the initial application.

Commission guidelines assign each change to its category, and the framework was revised in 2024 by a Commission delegated regulation.

Grouping mechanisms

Several variations may be submitted together in a grouped application. The worksharing procedure also allows the same variation affecting several authorisations to be subject to a single assessment conducted by a reference authority. Finally, urgent safety restrictions may be implemented provisionally, before any formal approval, at the initiative of the holder or at the request of the authority.

Variations and patent litigation

A Type II variation adding an indication falls within the global marketing authorisation and may, if it brings a significant clinical benefit, open the additional year of protection provided for a new indication. On the generics side, variations to the summary of product characteristics are decisive. A generic that has carved out an indication covered by a second medical use patent, then adds it by variation before the patent expires, is exposed to an infringement action. Monitoring published variations is therefore part of defending a portfolio.

Key points

Every change to an authorisation goes through a variation classified as Type IA, Type IB, Type II or extension, according to its impact on quality, safety and efficacy, the category determining the procedure and the time limit. Variations of indication directly affect data protection and second medical use patent litigation. Each change should be classified using the guidelines before it is implemented and, for a patent holder, variations to the summary of product characteristics of competing generics should be monitored.

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This glossary entry is general in scope and does not constitute legal advice.

Dhenne Avocats acts in pharmaceutical patent disputes and on the medicines regulatory questions that accompany them, from the marketing authorisation to the supplementary protection certificate.

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