Changes to variation rules start to apply from 2 November 2012

31 October 2012

A number of amendments to the Variations Regulation (Regulation (EC) No 1234/2008) that affect the provisions governing centrally authorised medicines will start to apply from Friday 2 November 2012.

The amendments are described in Commission Regulation (EU) No 712/2012, which entered into force on 24 August 2012. Although their main purpose was to extend the application of the Variations Regulation to marketing authorisations granted at national level so that all marketing authorisations granted in the European Union (EU) are subject to the same rules, a number of changes affect centrally authorised medicines. These include:

• changes to the decision-making process for variation procedures, so that changes that are critical for public health are reflected in marketing authorisations within two months, while other changes are reflected in periodic updates (within one year);
• the inclusion of compliance statements with the agreed, completed paediatric investigation plan in the marketing authorisation. Full details on the inclusion of the compliance statement with other technical information is available in the procedural note concerning the application of Articles 28(3), 36 and 37 of Regulation 1901/2006.

Information on explaining how the new rules will affect pending variation procedures and applications submitted following a worksharing procedure is available.

The Agency will be updating the post-authorisation procedural advice for users of the centralised procedure to reflect the changes to the Variations Regulation within the next few weeks.

Provisions governing purely nationally authorised medicines and applications submitted following a worksharing procedure start to apply on 4 August 2013.

The Variations Regulation, which has applied since 1 January 2010, describes how applications from marketing-authorisation holders for changes to existing marketing authorisations are handled, including the introduction of grouped applications and worksharing procedures. It applies to human and veterinary medicines.