Regulatory Requirements

Additional Insight into the Regulation of Medicines as the Brexit Clock Ticks

The Adents Team Written by The Adents Team
04-Mar-2019

As of February 26, 2019, the Medicines and Healthcare products Regulatory Agency (MHRA) has published an update of the guidance note regarding the regulation of medicines, medical devices, and clinical trials if there’s no Brexit deal on March 29, 2019.

This updated publication highlights consequences in the event there is no deal for these topics. These are detailed through the description of how it is currently regulated, how the MHRA proposes to regulate and then, by providing more details regarding specifics cases (e. g. Marketing Authorization “Grandfathering”, EU FMD requirements, new EU medical devices regulations, etc.)

MHRA to manage prescriptions medicines in the UK market

One of the challenges facing prescription medications would be the management of Centrally Authorised Products (CAPs) that will no longer be valid after March 29, 2019. In a first step, MHRA will apply the Grandfathering principle by converting these CAPs to UK Marketing Authorisation (MA) “Transitional provision in legislation will ensure that all currently granted CAPs automatically become UK MAs on exit day”. This means that functions currently undertaken by the EU will be managed by the MHRA for prescription medicines on the UK market.

Nevertheless, the MHRA specified that a guidance will be published to support MAHs to fulfill expected requirements after exit day.

EU FMD requirements no longer applicable

EU FMD has been enforced since February 9, 2019. Unfortunately, with the Brexit, SecurMed “The UK Medicines Verification Organisation” (UK NMVO) will no longer be connected to the European Hub (EMVO), this directly means that “UK stakeholders would no longer be able to comply with the requirement to verify and authenticate. Therefore, the legal obligations related to the FMD would be removed for all actors in the UK supply chain”. However, public safety and the fight against counterfeit products are still priorities for the UK government and it specified that options for a future UK falsified medicines regulatory framework will be evaluated, taking into account the investment already made.

UK approved Medical Devices at stake in EU

The second part of the Guidance note relates to medical devices. As a reminder, before the CE mark can be affixed, higher-risk medical devices (e. g. Class IIa, IIb and III) should be certified by an independent conformity assessment body, called a Notified Body (NB). In the event of no deal, devices certified by UK-based NBs will no longer be in compliance with the applicable EU Directive after March 29, 2019 (see specific UK guidance: https://www.gov.uk/guidance/regulating-medical-devices-in-the-event-of-a-no-deal-scenario).

In parallel, the UK government specified that all the key elements pertaining to regulations for medical devices (MDR 2017/745 & 746) will be transposed in a UK regulatory system as of March 30, 2019 to allow the full application of those two regulations on the UK market.

Want to know more about the consequence of the Brexit on the EU FMD enforcement? Read our previous article “Brexit – a bitter pill for the pharma industry

Want to Learn More?  Download our global serialization landscape for pharmaceutical products to have an overview of the state of the different laws and regulations pertaining to drug serialization and aggregation around the world as well as the main milestones.

The Adents Team
The Adents Team

The Adents Team: your serialization experts. With over 25 years of experience in different fields of product traceability, supply chain, big data and pharmaceutical serialization, our team members bring a wealth of knowledge to help you better understand the challenges and opportunities of serialization.

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