Changes to the Variations Regulation
When I think about Lifecyle management, once the MAA is obtained, what springs to my mind is variations, variations, variations. They are never ending and new challenges are always arising. Be it a change to a Marketing Authorisation Holder name, change to the packaging or change to an excipient, these all require submissions to allow the registered dossier to be updated.
After much discussion and consultation, as of 1 January 2025, a new EU ‘Variations Regulation’ has been implemented (Delegated Regulation (EU) 2024/1701). There are changes to the original Variations Regulation No 1234/2008 which aim to provide a simpler, clearer and more flexible way to manage variations.
The changes include:
- EMA and Member States annual review of unforeseen variations and regular updates to the variations guideline and Article 5 for unforeseen variations
- introduction of annual update for minor variations of Type IA
- inclusion of National MAs in super-grouping of Type IA variations
- streamlining variations of a human influenza or human coronavirus vaccine
- mandatory use of the Workshare procedure
- variations to human vaccines for public health emergencies.
The variations guideline, which sits under this, is under review and an update is expected during 2025. Until then, the current variations guideline should still be used.
UK Impact: Please note that this new regulation currently only applies to EU. As of now, the MHRA has not mandated the adoption of all amendments from the EU’s Variations Regulations 2024/1701. Please be aware that Type IA variations are to be submitted within 12 months of implementation, but the MHRA does not mandate an annual update system as described in the EU regulation – YET. However, recent intelligence shows that the MHRA are looking to align to the EU and will shortly provide a draft guidance update for applicants to comment on.
We will soon be running a series of blogs about some of the key updates that have come out of this new Regulation.
