With just over one month to go before “Brexit Day”, many companies that had been relying on the draft withdrawal agreement being implemented, or a delay to Brexit, are now also seriously considering the possibility of a “no deal Brexit” on March 29. While an orderly exit of the UK from the EU under the framework of a withdrawal agreement in its current draft form would provide some respite from many of the regulatory consequences of the UK becoming a third country, our customers are using PharmaLex’s combined EU and UK regulatory expertise and significant presence to directly address their need for a no-deal Brexit contingency arrangement – let’s consider it a kind of “regulatory backstop for medicines”.
We have already provided direct, practical support to many clients to enable them to be confident of sustained compliance in the EU, for example by transferring their orphan sponsorship to our German legal entity or transferring RMS for products approved through DCP or MRP to the NCA of another EU member state. Now we are experiencing a brisk level of enquiries from customers for solutions to also stay compliant in the UK. Typical services that our clients are reserving include:
- Assistance with establishment of a UK Legal Entity to act as MAH
- Preparation, publishing and submission of change of ownership applications to the MHRA.
- Acting as the local regulatory contact person in the UK for the MHRA.
- Provision of UK pharmacovigilance services, including UK QPPV and Deputy.
Our consultants are at your disposal to advise and deliver practical solutions to keep you covered on all aspects of EU and UK medicines regulation. Reserve your Brexit solutions now and contact us at firstname.lastname@example.org or on +44 (0)1628 530554.