This post provides information on the ongoing changes to the EU the variation Regulation (EC) No 1234/2008 and guideline.
Timeline of events leading to the publishing of the commission delegated regulation
| Date | Event |
|---|---|
| Call for evidence Feedback period 29 August 2023 – 26 September 2023 | This initiative, announced in the 2020 pharmaceutical strategy for Europe, aims to review the current rules setting out the procedures for post-authorisation changes to a marketing authorisation for medicines for human use. The purpose is to make the lifecycle management of medicines more efficient. Further information on this page. |
| Draft act Feedback period 07 February 2024 – 29 February 2024 | Further information on this page. |
| 11 March 2024 | The Commission adopted the Delegated regulation. Further information on this page. |
| 13 June – 23 August 2024 | Stakeholder consultation on the proposed amendments to the European Commission guidelines on variations categories and procedures. Further information provided below after the table. |
| 17 June 2024 | The amendments to the Variation Regulation (i.e. new measures for the better lifecycle management of medicine authorisations) were published in the Official Journal of the European Union. You can view them at the link below. Commission Delegated Regulation (EU) 2024/1701 of 11 March 2024 amending Regulation (EC) No 1234/2008 as regards the examination of variations to the terms of marketing authorisations for medicinal products for human use This Regulation shall enter into force on the twentieth day (7 July 2024) following that of its publication in the Official Journal of the European Union. It shall apply from 1 January 2025. This Regulation shall be binding in its entirety and directly applicable in all Member States. |
Stakeholder consultation on the proposed amendments to the European Commission guidelines on variations categories and procedures
As part of the 2020 Pharmaceutical Strategy for Europe, the Commission is reviewing the current rules governing the procedures for post-authorisation changes to the terms of a marketing authorisation for medicines products for human use, with the purpose to make the lifecycle management of medicines more efficient and future proof and ensuring the protection of public health in the European Union.
- In this context, the Commission proposed a draft delegated Regulation amending Commission Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and its annexes (Variations Regulation) within the existing legal framework of Regulation (EC) No 726/2004 and Directive 2001/83/EC.
- The draft delegated regulation was adopted on 11 March 2024 and Commission Delegated Regulation (EU) 2024/1701 was published in the OJEU on 17 June 2024.
- As a next step, the Commission is reviewing the Guidelines on the details of the various categories of variations and operation of the procedures (Variations Guidelines) and, in this respect, proposed amendments compatible with the current legal context are hereby released for the stakeholders consultation with a commenting period until 23 August 2024.
What are the main changes being proposed to the variations guideline?
Overall, the main changes proposed to the Introduction and Procedural section of the Variations Guidelines include:
- the addition of procedural details on the new/revised regulatory tools introduced with the proposed Variations Regulation (e.g. on super grouping of Type IA variations,
- annual update of Type IA variations,
- mandatory use of worksharing procedure and
- extension of update flexibility to human vaccines addressing a public health emergency in the Union.
Other changes being proposed to the variations guideline
Other changes include:
- The introduction and procedural guidance sections have been further simplified and updated to reflect the current practice of EMA and National Competent Authorities.
- The Annex to the Variations Guidelines, including the different categories, conditions and documents to be submitted has also been reviewed taking into consideration the experience acquired and the scientific and technical progress.
- Previous Article 5 recommendations for unforeseen variations have been integrated into the current proposal, as appropriate, and targeted proposals have been made on the administrative variations.
- The current code system for variations has been maintained, with the deletion of the Roman numeral“I” (relating to variations for human medicines) on the C-scopes and a sequential numbering implemented.
Documents provided in support of the consultation
The following documents are provided:
- Executive summary for proposed amendments to the European Commission guidelines on variations categories and procedures which can be viewed here.
- Track changed and clean versions of the document European Commission guidelines on variations categories and procedures: Proposal for stakeholder consultation
Where can you submit feedback to the consultation?
Before replying, please consolidate your comments at your EU trade industry association / organisation level.
Please submit your feedback only via the EU survey tool.
What are the consultation start and end dates?
Consultation start date: 13 June 2024
Consultation end date: 23 August 2024
Source: EMA