Navigating the Sunset Clause:
A Closer Look at PLGB MAs in the UK

As we approach the 3-year milestone since the conversion of EU Centrally Authorised Products (CAPs) into PLGB MAs (Marketing Authorisations) via the grandfathering process on January 1st, 2021, it is crucial for Marketing Authorisation Holders (MAHs) to be well-informed about the upcoming “sunset clause.” This clause is scheduled to come into effect on December 31st, 2023, with significant implications for these MAs.
The Transition from EU CAPs to UK PLGB MAs

Following the UK’s separation from the European Union on the 1st of January 2021, EU CAPs were converted into Great Britain Marketing Authorisations in the UK (PLGB MAs) via the “grandfathering” process. This allowed pharmaceutical companies to continue marketing in the UK, albeit under new regulations.

Approaching the 3-Year Milestone

With the 3-year anniversary approaching, MAHs must understand the implications of the sunset clause. Failure to commercialise PLGB MAs or inform the MHRA of marketing commencement may result in notifications from the MHRA regarding the approaching sunset clause date.

Planning for Sunset Clause Exemptions

Exemptions from the sunset clause can be submitted, but not more than 3 months in advance (i.e., not before 01/10/2023). MAHs should carefully consider their options regarding these MAs and whether they intend to apply for an exemption, and if so, determine the grounds on which they will apply.

MAH Responsibility

In conclusion, as the 3-year anniversary of the conversion of EU CAPs to PLGB MAs in the UK approaches, MAHs need to take proactive steps to navigate the sunset clause. Understanding the implications, planning for exemptions, and monitoring individual MAs are critical elements of ensuring compliance with UK pharmaceutical regulations.

The sunset clause may be approaching, but with the right strategy, MAHs can navigate these changes smoothly and continue to contribute to the healthcare landscape in GB. At JensonR+, we understand the complexities of regulatory transitions and are here to support your business through these challenges. Please get in touch with us if you would like specialist support for your business. Our experts are ready to assist you in ensuring compliance and maintaining a strong presence in the UK pharmaceutical market.
Lauren Foster
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