Last updated: 3 July 2025
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This post provides information on the ongoing changes to the EU the variation Regulation (EC) No 1234/2008 and guidelines.
The commission delegated regulation
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 entered into force on the twentieth day (7 July 2024) following that of its publication in the Official Journal of the European Union. It became applicable on 1 January 2025. This Regulation shall be binding in its entirety and directly applicable in all Member States. This regulation revised the current rules setting out the procedures for post-authorisation changes to a marketing authorisation to make the lifecycle management of medicines for human use more efficient and future-proof. |
Guidance on the implementation of the amended Variations Regulation (EU) 2024/1701 for variation applications implemented and submitted from 1 January 2025.
Guidance is available here on the implementation of the amended Variations Regulation (EU) 2024/1701 for variation applications implemented and submitted from 1 January 2025 (see below).
What will happen during the transition period from 1 January 2025 until the date when the updated Variations Guidelines become applicable?
During this transition period, from 1 January 2025 and until the updated Variation Guidelines become applicable, marketing authorisation holders (MAHs) should continue to rely on the current classification part of the Variations Guidelines and on specific procedural guidance that is available on the CMDh website.
Are there any changes to variations submitted before 1 January 2025?
Variation applications submitted before 1 January 2025 will still follow the current provisions as defined in Regulation (EC) No 1234/2008 as amended by Commission Delegated Regulation (EU) 2021/756 until their conclusion.
CMDh – FAQs on the Revised Variations Regulation
The CMDh convened a meeting with Interested Parties on 19 June 2025.
Here is a link to the slide deck of FAQs as discussed during the meeting.
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
What were the consultation start and end dates?
Consultation start date: 13 June 2024
Consultation end date: 23 August 2024
The consultation is now closed.
Consultation outcome
Following the revision of the Variation Regulation applicable since 1 January 2025, the European Commission has now published a draft version of the new EC guidelines on the details of the various categories of variations and operation of the procedures and expects them to apply from 15 January 2026 (as provided in the published draft version of variations guidelines).
Updated guidance
On 30 June 2025, updated guidance has been published on the EMA website and on the CMDh website regarding the application of the new variation framework and the impact on the submission of variations. Stakeholders are invited to view the information and to take the necessary measures to prepare their systems, processes, procedures and documentation for compliance with the revised variation framework.
- EMA and CMDh will publish more guidance regarding the implementation of the new variation categories.
- Stakeholders should continue to monitor the webpages on EMA and HMA websites mentioned at the Variations framework section. They should also take the necessary measures to prepare their systems, processes, procedures and documentation for compliance with the revised variation framework.
- In case of doubt, MAHs should contact the relevant competent authority.
Implementation of the revised variations framework
- A single cut-off date for the entry into application (i.e., 15 January 2026) is foreseen as set out in the draft version of the Variations Guidelines.
- Until 15 January 2026, marketing authorisation holders should continue to rely on the current Variations Guidelines and on the specific procedural guidance.
| Variation type(s) | Submitted before 15 January 2026 | Submitted as of 15 January 2026 |
|---|---|---|
| Type-IA variations To facilitate the transition for Type IA variations and minimise the overlap of the two systems the rules stated should apply. | For all Type-IA variations implemented before 15 January 2026 should be submitted before 15 January 2026 using the current electronic application form (eAF) version. If no annual update is due before 15 January 2026, the MAH should submit said implemented variations preferably as an earlier annual update submission or otherwise as individual notifications outside the annual update. | The first type IA variation implemented as of 15 January 2026 will start a new cycle for the annual update, unless one of the listed annual update exemptions applies to that variation. |
| For Type-IB and / or Type-II variations | These types of variations will follow the current Variations Guidelines until the procedure is completed (even if completed after 15 January 2026). MAHs should use the current electronic application form (eAF) version for these submissions. | These types of variations will follow the new Variations Guidelines. MAHs should use the updated eAF version for these submissions. |
| All variations | The new variation classification categories and the updated electronic application form (eAF) cannot be used in anticipation of the entry into application of the new Variations Guidelines. Any variations submitted before 15 January 2026 using the updated eAF version and / or a new variation category will not be validated and the marketing authorisation holder (MAH) will have to revise its application. | MAHs should use the updated eAF version. The updated eAF will be published before 15 January 2026 to enable MAHs to prepare applications planned for submission after 15 January 2026. |
Sources: CMDh, EMA (amended variations regulation), EMA (variations guideline)