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:
The BfArM fully supports the instructions already made available as well as the regulations published on the European level.
The BfArM draws particular attention to the fact that the following persons or activities must be located within the EU or the EEA in order for the medicinal products to be marketed in the EU in the case of hard Brexit:
- Marketing authorisation holder and applicant
- Batch control and release
- Quality Control (QC)
- Qualified person (QP)
- Qualified person for pharmacovigilance (QPPV)
- Stufenplanbeauftrager according to art. 63a German Drug Law (in an EU-country)
- Pharmacovigilance Master File (PSMF)
The transfer of the above-mentioned persons and activities to the EU or the EEA must take place before 30 March 2019. In ongoing DCP approval procedures, the corresponding changes can be submitted with the day 106 or day 160 response. In current MRP procedures only a change of the applicant or the future MAH with the day 40 response is possible, all other changes must be applied for and completed by variation before the start of the MRP.
Batches that have already been released and for which the aforementioned persons or activities are still based in Great Britain but which were brought into the EU or the EEA before 30 March 2019 may still remain on the market. New batches for which the aforementioned persons or activities are still based in Great Britain after 29 March 2019 may no longer be imported into the EU or the EEA as of 30 March 2019.
New marketing authorisation procedures with Great Britain as RMS must be completed on 29 March 2019, otherwise they end without result and must be submitted again with a new RMS.
Current variation or renewal procedures that are not completed on 29 March 2019 end without result and must be resubmitted with a new RMS.
If the transfer of the RMSship for authorised medicinal products from the UK to any CMS has not taken place before 30 March 2019, the marketing authorisations concerned will remain valid. However, a new RMS must be appointed for the next regulatory activity. In case of doubt, the CMDh supports the appointment of the new RMS.
For ongoing generic new marketing authorisation procedures with a reference product approved in the UK, licences must be granted before March 30, 2019. If the procedures are still pending at this time, no marketing authorisation can be granted anymore.
If a bioequivalence study against a reference medicinal product approved in Great Britain is used in generic new marketing authorisation procedures, the application must be submitted before March 30, 2019 and the study must be completed before this deadline. Only for MRP and repeat use can the application be submitted after 29 March 2019 if the batches used were manufactured when the UK was still a member of the EU.
Further questions regarding "Brexit" can also be submitted to the BfArM by email to firstname.lastname@example.org. Requests for RMS switches can be sent to RMSemail@example.com using the template provided by the CMDh.
Furthermore, the BfArM will be publishing its own FAQ based on inquiries it receives unless these are already covered by the published European regulations.