On 12 March, the European Commission adopted a proposal for a Delegated Regulation to amend Regulation (EC) No 1234/2008 as regards the examination of variations to the terms of marketing authorisations for medicinal products for human use.

Scientific and technological advancements have led to a rise in the number of requests for variations to marketing authorisations (MA) and have brought the need to revise the variations procedure to make it more efficient and adaptable to change, in particular in relation to biological medicinal products, vaccines and medical devices.

The proposal aims to make the variations procedure simpler, clearer and more flexible to be able to respond to scientific and technological progress, and to reduce administrative burden.

The changes introduced by the proposal include:

  • Possibility to submit a single application for super-grouping of variations (i.e. grouping several variations involving more than one MA into a single submission)
  • In the case of purely national MAs: competent authorities may process the variations under the worksharing procedure to avoid duplication
  • Re-classifying variations related to the quality and manufacturing aspects of biological medicinal products: Under the proposal, these variations will no longer be classified as major variations by default. In practice, this means that the procedure would be potentially less demanding, with less comprehensive data having to be submitted and a shorter procedure
  • Regular update of the Variations Guidelines to introduce new classification of variations and updates to the guidelines when necessary
  • Streamline process for minor type IA variations (e.g. changes to a company’s address): MAHs will be able to report minor type IA variations annually instead of immediately, in a single combined notification (subject to exceptions where an immediate notification may be required)