Targeted stakeholder consultation on the pilot project ‘Market Launch Intentions of Centrally Authorised Products’
Period of consultation
22 June to 22 July 2020 (12.00 CET)
Marketing authorisation holders and companies/businesses involved in the application for marketing authorisation of centrally authorised medicinal products for human use (CAPs) to the European Medicines Agency. Comments from small and medium-sized enterprises (SMEs) are particularly welcome. Comments from any other interested party are welcome.
Objective of the consultation
In the EU, a medicinal product can be placed on the market after it has received a marketing authorisation. A centralized marketing authorisation granted by the European Commission is valid throughout the EU, allowing the marketing of the medicinal product in all Member States. However, in practice, there are still important differences as regards when (if at all) a newly (centrally) authorised medicine is made available in each EU Member State.
The lack of availability of medicinal products in many Member States, particularly in those with smaller population sizes, is a general concern that has also been highlighted in the roadmap of the recently published EU Pharmaceutical Strategy. It poses a particular challenge to the underlying principle of the centralised authorisation procedure. This procedure was designed to serve wide availability to patients and healthcare professionals throughout the EU by allowing marketing authorisation holders to commercialise authorised medicinal products in each Member State based on a single marketing authorisation.
In order to increase availability of CAPs, an ad hoc working group was set-up under the Human Pharmaceutical Committee, bringing together the Commission, national competent authorities and the European Medicines Agency, to consider possible actions which could help improve a wider roll-out of CAPs. One of the agreed actions is a ‘pilot project’ to raise awareness on this issue and engage with prospective marketing authorisation holders through voluntary sharing of their marketing intentions for specific types of CAPs in the pre-authorisation phase, and to improve regulators’ knowledge on the mechanism behind delayed market launch. Prospective marketing authorisation holders participating in this pilot will be invited to share this information on a confidential basis.
This pilot will be restricted to MAHs of orphan medicines and/or oncology medicines.
With this online consultation, we seek the stakeholders’ feedback on the proposed pilot project and its template for ‘Market Launch Intentions.’
The comments and suggestions received will be considered in the work leading to the implementation of this pilot project, which should start later this year.
Responsible service: Directorate-General for Health and Food Safety, Unit B5 - Medicines: policy, authorisation and monitoring
How to submit your feedback
Please send your feedback by using the EU Survey link below.