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Consequences of "Brexit": BfArM's preparations

Consequences of "Brexit": BfArM's preparations

After the so-called "Brexit", the United Kingdom's medicines agencies for human and veterinary medicines (Medicines and Healthcare Products Regulatory Agency, MHRA and Veterinary Medicines Directorate, VMD) will presumably no longer be available for licensing procedures regarding medicinal products within the European Union (EU). "Brexit" will especially affect the evaluation of medicines in relation to their manufacture, development, licensing and pharmacovigilance. The experts of the German Federal Institute for Drugs and Medical Devices (BfArM) are preparing to take on additional tasks in the future.

In a referendum, the United Kingdom has decided to withdraw from the EU ("Brexit"). As a result of this procedure initiated under Article 50 of the EU Treaty, the United Kingdom will leave the EU on 30 March 2019.

Until this date, the United Kingdom will remain a full member of the European Union. It depends on the outcome of the negotiations which implications this withdrawal will have for the United Kingdom and the other Member States of the EU. However, considerable consequences for the distribution and marketing of medicinal products can be expected.

It is the BfArM's main objective to maintain the availability of medicinal products for patients during and after the negotiations. In order to compensate for bottlenecks in the European regulatory network, the BfArM intends to further strengthen its role within the European network and to increase its capacities for taking on additional central and decentralised (MRP/DCP) licensing and follow-up procedures as well as to increase its efforts in the areas of clinical trials and inspections as well as pharmacovigilance.

The BfArM sees itself as a "full-provider", i.e. these additional capacities will be created for all additional tasks in order to ensure that the procedures can be transferred for all therapeutic areas without limitations. This applies both to the increased acceptance of new applications for marketing authorisation as well as to the transfer of procedures so far within the United Kingdom's responsibility. However, especially in the case of transfers of existing marketing authorisations, the so-called "RMS switch", we strongly recommend submitting these as soon as possible in order to avoid a transfer backup shortly before "Brexit" takes effect. In this connection, the BfArM refers to the guidance paper issued by the Co-ordination Group (CMDh).

On the European level, all committees have established working groups regarding the subject "Brexit" which will be publishing European regulations promptly on the corresponding internet pages:

EMA
HMA
CMDh

The BfArM fully supports the instructions already made available as well as the regulations published on the European level. Further questions regarding "Brexit" can also be submitted to the BfArM by way of the contact form.

Furthermore, the BfArM will be publishing its own FAQ based on inquiries it receives unless these are already covered by the published European regulations.

Can I switch from UK as the RMS to another country during an ongoing licensing or follow-up procedure?

In accordance with the "CMDh Procedural Advice on Change of the Reference Member State" http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/01_General_Info/CMDh_039_2002-Rev5-2017_03-Clean.pdf , an RMS switch cannot take place during an ongoing licensing or follow-up procedure.