The European Commission wants to respond quickly to any changes in medicinal products on the market.

UM – 09/2023

The European Commission wants to simplify and increase the efficiency of the procedures for notifying changes for medicines that have already been authorised. In plain language: The administrative burden on marketing authorisation holders and authorities is to be reduced and resources made available. There are enough opportunities for rationalisation.

Do not wait for the new laws on medicinal products

There should be a legislative proposal on this in the fourth quarter of this year. This would thus take place years earlier than the conclusion of the legislative initiatives on European pharmaceutical legislation, the drafts of which were published on 26 April this year. On 29 August, the European Commission launched a Consultation to gather input from the stakeholders concerned. It ends on 26 September 2023. The German Social Insurance (DSV) contributed to the opinion-forming process with a statement and called for more clarity in the procedure.

Raising efficiency reserves in the marketing authorisation process

By means of a delegated regulation, additional instruments are to be proposed within the current legal framework for changes to the conditions of authorisation of medicinal products and efficiency gains are to be made possible. The facilitations refer to medicinal products in whose product cycle changes to the contents of the marketing authorisation have occurred, for example due to new scientific findings or a change in technology. All changes to ensure the quality, safety and efficacy of the medicinal product concerned and its manufacture and control in accordance with the relevant recognised methods must be notified. This is because these changes are subject to review by the competent authority in the same way as initial marketing authorisations.


In the course of the upcoming delegated regulation on marketing authorisation changes, the recommendations on unforeseen changes for medicinal products are also to be aligned with the new provisions of the Medical Device Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR). In addition, the risk-based approach for categorising changes is to be extended to certain biological medicinal products.

Revision of medicinal products in partial steps

According to statements by the European Commission, the pre-decided regulations will be included in the complete revision of the framework for changes that will arise in the future with the implementation of the revision of the European pharmaceutical legislation.


The new regulation of the procedures for amending marketing authorisations is not the first or only example of creating regulatory acts outside the planned revision of medicinal products. Significant impulses for combating antimicrobial sympathies were launched right with the publication of the medicinal product package via a proposal for a Council Recommendation and have since been adopted. The European Parliament, the Council and also the European Commission also endorse a separate legal act on supply-critical medicinal products. Behind this is the political goal of reshoring production or parts of production to Europe to ensure the availability of such medicines. The initiative for this came from Belgium and was supported by 18 other Member States (see also  DSV News June 2023). It seems a bit like the pharmaceutical revision is being implemented step by step.