Regulatory information - Revision of procedural guidance to reflect update of variations guidelines from the European Commission
The European Medicines Agency has revised its procedural guidance for pharmaceutical companies to reflect the recent changes to the European Commission’s guidelines on variations to the terms of marketing authorisations for medicines for human and veterinary use. Changes are applicable as of 4 August 2013.
This revision of the variations guidelines has been principally triggered by the implementation of the pharmacovigilance legislation. It also takes into account the experience gained since the release of the current guidelines.
The main changes of the revision include the creation of two new classification categories of variations:
- C.1.11 related to obligations and conditions of a marketing authorisation, including risk management plans;
- C.1.13 related to submission of studies to a competent authority; as a result some of the data previously submitted as a post-authorisation measure will now need to be filled as variations applications.
To assist pharmaceutical companies in the implementation of these new requirements, the Agency has developed an overarching Q&A document providing an overview of the most important changes which apply to applications for a variation and submission of post-authorisation measure data for human medicines.
In addition, the Agency has updated a number of existing guidance documents to reflect the new requirements.
The Agency will publish another set of regulatory updates by 4 August 2013. It will include:
- a revised guidance document related to work-sharing procedures for variations to marketing authorisations;
- an amended template table to be used for any variations submission to the Agency;
- a tabular overview with more detailed information on the updated documents.
Pharmaceutical companies are advised to check the What's New page on the Agency’s website to find these updates.
The revision of the variations guidelines mostly affects applications for human medicines. Guidance documents related to veterinary medicines will be updated to reflect the changes to the variations guidelines shortly.
- New variations regulation: Regulatory and procedural guidance
- Presubmission guidance: Q&A
- Human post-authorisation Q&A
- 2010 pharmacovigilance legislation