Prepared for Brexit?
Under current expectations, the UK will leave the European Union on 29 March 2019 and become a so called 'third country’. The pharmaceutical industry is likely to be significantly affected by Brexit and there will probably be an impact on Marketing Authorisation Holders (MAHs) and pharmacovigilance (PhV) activities, as well. If you consider that your company may be impacted by these changes, Medfiles is ready to help you get prepared with a range of personalised services:
• EU batch control/testing and QP certification
Manufacturing and supply chains are also likely to be affected because – according to European legislation – the batch release activities must be performed in the EU (or EEA). Medfiles laboratories have a GMP license and a GMP certificate. We offer you comprehensive services for chemical and microbiological quality control of finished products, re-analyses of pharmaceutical products for the EU market and batch certification by a Qualified Person (QP).
• Regulatory procedures
The Reference Member State (RMS) must be a member state of the EU (EEA). If the current or planned RMS is the UK, it will need to be changed to an agency of a member state of the EU (EEA). Additionally, for any European medicinal product licenses held by UK legal entities, transfer of the marketing authorisation to a new holder is likely to be required. Medfiles Regulatory Affairs personnel is able to help you with all regulatory changes related to Brexit.
• Pharmacovigilance activities
PSMF & QPPV location must also be inside the EU (EEA). Our pharmacovigilance team consists of highly dedicated professionals and we can provide you with comprehensive EU QPPV services.
• Products on the UK market
Products which are marketed in the UK will most likely need to be tested and released inside the UK. Medfiles can find local operators via the international regulatory partner network Regulanet® or our UK-based laboratory contacts. Via the Regulanet® partner network, we are also able to support you with local UK regulatory and PhV requirements in the future.
• Comprehensive project management
Medfiles offers comprehensive project management and helps you in risk evaluation, gap analysis, planning, scheduling and detailed problem-solving in issues related to Brexit, e.g. in finding new batch control/release sites, managing method transfers and coordinating variations.
For further information on how Medfiles can help you through Brexit, please contact
Director, Regulatory Affairs
Tel. +358 20 7446 821
Director, R&D and Laboratory Services
Tel. + 358 20 7446 816
Clinical Study and PhV Services:
Director, Clinical Research
Tel. +358 20 7446 854