The delegated regulation amending Regulation (EC) 1234/2008 and addressing variations to marketing authorisations has been published in the Official Journal of the European Union on 17 June 2024 (Delegated regulation – EU – 2024/1701). The regulation is related to the 2020 pharmaceutical strategy for Europe and aims to review the current rules that set out the procedures for post-authorisation changes to marketing authorisations for medicines for human use. The purpose of the initiative is to streamline procedures in order to promote a more efficient life-cycle management of medicines. These changes are considered an intermediate step towards the greater reform of the pharmaceutical legislation in the European Union and its upcoming changes.
The changes in the delegated regulation involve amendments to Commission Regulation (EC) No 1234/2008. For example, references to veterinary medicinal products will be deleted from the Regulation and updates of human coronavirus vaccines will be streamlined to be in line with the approach taken with human influenza vaccines, also outside public health emergencies. The objective is to make the life-cycle management of medicines more efficient and to simplify the processing of variations by the authorities, through for example the following measures:
- The term “super-grouping of variations” will be introduced in the Regulation, although super-grouping has already been used for type IA/IAIN variations for groups of products with different RMSs, as guided by the CMDh. The updated Regulation will include purely national marketing authorisations in the super-grouping, to harmonise national marketing authorisations in different member states.
- A risk-based approach will be implemented for handling variations by reclassification of some changes into lower categories:
- the extension of an approved design space can be applied as type IB instead of type II variation.
- changes to a medical device that is an integral part of, or in exclusive use with, a medical product will be classified as type IA, if there is no impact on the quality, safety or efficacy of the medicinal product.
- New classifications of variations from Article 5 procedures will be published without delay in the electronic version of Commission Regulation (EC) No 1234/2008 on the Commission website.
- Submitting IA variations as annual updates or parts of groupings of variations will be encouraged.
The changes aim to improve efficiency, reduce the administrative burden on the pharmaceutical industry and make better use of the resources of the regulatory authorities with variations that can be processed in a simpler way.
A proposed amendment to the guidelines on the details of the different categories of variations and operation of the variation procedures has been published for comments from the stakeholders: Variations guidelines: Proposed amendments to the European Commission guidelines on variations categories and procedures. EMA requests the feedback by 23 August 2024.
Our team of highly competent experts with extensive work experience in the pharmaceutical industry and with regulatory agencies classifies your variations in accordance with the updated guidelines, consults in studies needed to support the change, helps you in preparation of the variation documentation and takes care of the regulatory activities and eSubmission. You will receive a comprehensive marketing authorisation maintenance service for your medicinal products.
