After four years and six months, the result of the Brexit referendum has been acted upon. The implications for Marketing Authorisation Holders (MAH) need to be understood and the requisite actions taken. Here we review the details, updates, and implications for ensuring regulatory compliance now that the UK has left the EU.
Before delving into updates for the legislations, here is a quick summary of the definitions for the countries impacted.
The UK is comprised of four separate “countries: England, Scotland, Wales (Great Britain), and Northern Ireland. The differentiation between Northern Ireland and Great Britain has numerous consequences for MAHs within the pharmaceutical industry.
Northern Ireland (non-EU) shares the island of Ireland with the Republic of Ireland (EU). To ensure alignment with the agreements made under the 1998 Good Friday agreement to ensure no border between the two countries, the Northern Ireland Protocol was drawn up and signed as part of the Brexit deal. This means that despite being part of the United Kingdom, Northern Ireland will continue to enforce the EU customs rules and follow EU rules on product standards.
“XEVMPD, Medical Devices, and the management of UK-wide, GB & NI-only medicinal product licenses all bring additional complexity for Life Sciences going forward.”
– Karen Harry, Calyx
Grandfathering is the term used to describe the process of removing GB from Licenses approved via the EU Centralised Procedure (CP). As of 11 pm on 31 December 2020, the MHRA converted all EU Centrally Approved Products (CAP) Marketing Authorisations into national GB licenses; Northern Ireland remains part of the EU CP. MAHs will need to submit baseline GB submissions to the MHRA before January 2022. Updates to Patient Information Leaflets (PIL), Labelling and Packaging need to be planned accordingly. As a rule, MAHs will not be able to vary or renew licenses prior to the submission of the baseline, although there are some exceptions
Great Britian can no longer be included in EU procedures. For those previously approved under MRP or DCP, the MHRA have provided MAHs with three options to manage their UK Marketing Authorisation. Each has different implications and needs to be considered accordingly.
Several new Procedures have been introduced by the MHRA to expedite the review of new products in GB.
- Unfettered Access Procedure
- European Commission Decision Reliance Procedure (ECDRP)
- MRDC Reliance Procedure (MRDCRP)
These are all based on the assessments and approval of products in the EU.
Over time, the same product approved in the UK may have different registered details dependent on whether the product is on the GB or NI market. Although this sounds daunting, it is a scenario that is managed on a global basis daily and will not be an insurmountable barrier.
“The reality for marketing authorisation holders is the need to understand numerous guidance documents, update RIM databases and publishing dossiers, and schedule submissions.”
-Amy Williams, Calyx
The Brexit agreement has been in the news a lot over the last months. With the latest debates about the impact of the Northern Ireland protocol and the potential use of “Northern Ireland as a back-door for vaccines,” friends and acquaintances now engage in conversation about regulatory procedures. “MHRA,” “EMA,” and “Northern Ireland protocol” come up in day-to-day conversations, over zoom calls, and in supermarket queues.
The reality for marketing authorisation holders is the need to review and understand numerous guidance documents, update RIM databases and publishing dossiers, and schedule submissions. Getting this right and keeping medicinal products on the market for patients who depend on them is of absolute criticality.
At Calyx we continue to monitor the changes from the MHRA and share these with our clients. Contact us at [email protected] if you have questions and would like to talk to an expert.