There is no doubt you are aware of the UK’s intention to leave the EU on Friday 29th March 2019, and that following the planned departure, EU law – including those on medicinal products – shall cease to apply in the UK.

Nevertheless, there are still ongoing negotiations on the future arrangements between the EU and UK, and the outcome of these negotiations is uncertain.

In view of these considerable uncertainties, the European Medicines Agency (EMA) and EU National Competent Authorities (NCAs) are preparing for a no-Brexit-deal scenario: a so-called “Hard Brexit”.

In particular, they’re getting ready for the possibility that after Brexit, new Marketing Authorisation Applications (MAAs) will have separate approvals in the European Economic Area (EEA) and the UK and the management of pharmacovigilance activities, batch release, and quality control, including importation sites for human and veterinary medicinal products, will no longer remain aligned.

Also, it is anticipated that the sharing of common systems for formal exchange and recognition of data submitted for regulatory activities between the UK and EU countries may cease.

Consequently, the Medicines and Healthcare products Regulatory Agency (MHRA) will assume primary responsibility for the oversight and conduct of all pharmacovigilance and regulatory activities in relation to UK Marketing Authorisations (MAs).

EMA has started relocating its staff from the UK (London) to The Netherlands (Amsterdam), and has initiated preparations to ensure the continuous delivery of its mission to protect public and animal health after the UK leaves the EU.

What’s more, it has developed a business-continuity plan to ensure operational continuity and redistributed the UK’s portfolio of over 370 Centrally Authorised Products (CAP) to rapporteurs and co-rapporteurs within the EEA.

In addition, NCAs foresee a significant increase in their workload, as over 3,500 Mutual Recognition Procedures (MRP), Decentralised Procedures (DCP) and Repeat Use Procedures (RUP) will require a change of Reference Member State (RMS).

And that’s not all, over 200 Periodic Safety Update Report (PSUR)/Periodic Safety Update Single Assessment (PSUSA) procedures and benefit-risk monitoring/signal-detection responsibilities for 136 active substances will require redistribution from the MHRA to another NCA.

In order to prepare and support industry stakeholders, and to minimise any potential impact on public health, safety, efficacy and the quality of medicinal products while promoting continued supply, several guidance and Q&A documents have been published by the EMA and other regulatory bodies, for example:

Furthermore, in July 2018, EMA published their “Report from EMA Industry Survey on Brexit Preparedness” (EMA/450315/2018 Corr. 1), using insight gathered from over 180 Marketing Authorisation Holders (MAHs) of the 694 CAPs (661 human and 33 veterinary products) located in the UK.

The survey highlighted that 400 medicines will require a transfer of the MA to a MAH based in the EEA, 335 CAPs will require a change to the location of the EU Qualified Person for Pharmacovigilance (QPPV), and 376 medicines for human use will require a change to the location of the Pharmacovigilance System Master File (PMSF).

Overall, EMA and the NCAs strongly advise that companies should prepare for a “Hard Brexit” scenario and review their systems to identify any actions required. Brexit-preparedness plans should be established to guarantee the continuous supply of medicines for patients. They must also submit the necessary changes for the continued maintenance of their MAs to EMA or NCAs as early as possible to ensure processing in due time.

As a result of the required changes to MAH pharmacovigilance systems, NCAs predict that there will be an increase in the number of pharmacovigilance inspections.

To discover how ADAMAS can help you overcome the obstacles that a “Hard Brexit” may put in place, contact us on +44 (0)1344 751 210 or at info@adamasconsulting.com , or visit our website at www.adamasconsulting.com.

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ADAMAS’s consultants have expertise across the G’X’Ps in pre-clinical, clinical and post-licensing areas. They have worked across many different therapeutic areas and product types including oncology, vaccines, biologics, medical devices and gene therapy. As a company we have developed close partnerships with our clients to support them in their development programmes and post-licensing activities, and to guide them successfully through their worldwide regulatory inspections.

 

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