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
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.