Effects of Brexit: The Paul-Ehrlich-Institut is making preparations
After the Brexit the UK's agencies for human and veterinary medicines (Medicines and Healthcare Products Regulatory Agency, MHRA and Veterinary Medicines Directorate, VMD) will probably no longer be available for EU marketing authorisation procedures.
Product testing and issuing EU certificates for official batch releases are also affected by the Brexit. Experts of the Paul-Ehrlich-Institut (PEI) are preparing themselves for taking over additional duties.
- Involvement in the regulatory field
- Notes for applicants
- Information on Brexit from the European organisations
The United Kingdom (UK) decided to withdraw from the EU (Brexit) in a referendum. Following a procedure induced pursuant to Article 50 of the EU Treaty, the UK's official withdrawal from the EU will take place on 30 March 2019. Until that date, the UK will remain a full member of the EU.
Involvement in the regulatory field
The PEI, Federal Institute for Vaccines and Biomedicines, is preparing to expand its involvement in the European network of medicines authorities. It will increase its staff capacities to assume procedures which have been the responsibility of UK authorities, thus preventing potential bottlenecks. Such procedures include:
- Mutual Recognition Procedures (MRPs) and Decentralised Procedures (DCPs) as well as their follow-up procedures – HMAs
- Centralised marketing authorisation procedures and their follow-up procedures – EMA
- Batch release tests and product tests within the OMCL network – EDQM
In addition, the PEI is stepping up its activities in the areas of authorisations of clinical trials as well as field trials, scientific advice, inspections and pharmacovigilance, if required.
Notes for applicants
MRP/DCP authorisations to be assumed by the PEI
The availability of human and veterinary medicines must be guaranteed after the Brexit as well. The PEI recommends that application holders should react in a timely manner before the UK's withdrawal from the EU and proactively check existing marketing authorisations for necessary changes. Especially MRP/DCP authorisation procedures with UK as reference member state (RMS) must be transferred to other EU (or EEA) member states in a so-called "RMS switch". Marketing authorisation holders are expressly recommended to initiate this switch as soon as possible to avoid bottlenecks shortly before t the Brexit is coming into force. The PEI supports such an RMS switch by providing advice and will be prepared to act as a potential new RMS.
Please submit your questions concerning the procedure to:
Product tests as OMCL to be assumed by the PEI
The PEI is interested in a close dialogue with manufacturer to take over additional tasks within official batch and product testing in the accredited laboratory areas and is happy to support a transfer of OMCLs (veterinary and human).
Please send your questions on the procedure to:
- firstname.lastname@example.org for product testing
Information on Brexit from the European organisations
The relevant European organisations have established working parties on the subject of Brexit which will publish European decisions and FAQs on various questions on their internet pages in a timely manner.
Heads of Medicine Agencies (HMA)
- Co-ordination Group for Mutual Recognition and Decentralised procedures - Human (CMDh)
- Co-ordination Group for Mutual Recognition and Decentralised procedures – Veterinary (CMDv)
European Medicines Agency (EMA)
European Directorate for the Quality of Medicines & Healthcare (EDQM)
The OMCL network (Official Medicines Control Laboratories) has not yet published any specific information. Links containing such information will be available here as soon as the information is published.
- Questions and Answers related to the United Kingdom's withdrawal from the European Union with regard to the medicinal products for human and veterinary use within the framework of the Centralised Procedure
- Notice to marketing authorisation holders of centrally authorised medicinal products for human and veterinary use