The European Medicines Agency (EMA) has updated its page on the "Application of the Amended Variations Regulation from 1 January 2025". This regulation update aims to streamline the process for managing changes to approved medicinal products in the European Union, ensuring continued product safety, efficacy, and quality while simplifying administrative procedures for applicants.
The Variations Regulation provides a structured framework for managing post-authorization changes to medicinal products, including modifications to the manufacturing process, labeling, and product composition.
This framework facilitates the efficient processing of variations while maintaining regulatory oversight to ensure product quality and safety.
This guidance provides instructions on the implementation of the amended Variations Regulation applicable as of 1 January 2025, including amendments to the Article 5 procedure, minor variations of type IA, grouping and supergrouping of type IA variations, a vaccine update on human influenza or Coronavirus every year, use of the work sharing procedure both mandatory and voluntary, variations to human vaccines during emergencies, and the Annex.
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.
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 below and on the CMDh website.
Guidance is available on implementing the amended Variations Regulation (EU) 2024/1701 for variation applications implemented and submitted to the Agency from 1 January 2025. The EMA and CMDh websites should be monitored by stakeholders, and they should prepare their systems, processes, procedures, and documentation accordingly.
This shift aligns with the EMA’s ongoing digital transformation efforts to increase transparency and efficiency in regulatory operations. For more detailed information, please refer to the full EMA guidance here.
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