Changes to Variation Rules started to apply

A number of amendments to the Variations Regulation (Regulation (EC) No 1234/2008) that affect the provisions governing centrally authorised medicines started to apply on 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);
  • Inclusion of compliance statements with the agreed, completed paediatric investigation plan in the marketing authorisation.

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 work sharing procedure start to apply on 4 August 2013.

Source: EMA Press Release

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