Written question – Safety of medicines authorised on the market by means of an emergency marketing authorisation – E-002229/2025

Question for written answer  E-002229/2025
to the Commission
Rule 144
Ton Diepeveen (PfE)

Regulation 2023/0131 pursues the general objective of ensuring a high level of public health by guaranteeing the quality, safety and efficacy of medicines for patients in the EU. In addition, this regulation provides for the possibility, in the event of a health crisis, to grant an emergency marketing authorisation on the basis of limited data. Such authorisation should be granted only if the benefits of the immediate availability of the medicinal products outweigh the risks stemming from the absence of complete data.

• 1.In what way does the proposed emergency marketing authorisation ensure the safety of medicines, given that such authorisation is granted on the basis of limited data?
• 2.The risk-benefit trade-off is by definition subjective and only in retrospect can it be determined whether the correct decision was taken. How does the Commission evaluate this trade-off ex ante, given that the full data on the medicine – and thus the risks involved – are not known at that point?
• 3.Who bears the final responsibility for marketing a medicine by means of an emergency marketing authorisation if it turns out subsequently that the medicine should never have been marketed owing to the risks involved?

Submitted: 4.6.2025