Insight to Acquiring PL License across the United Kingdom from PLGB (Product License Great Britain) or PLNI (Product License Northern Ireland)

A brief history of BREXIT and the implications on Marketing Authorisations in the UK

An event known as Brexit occurred on 29 March 2017 when the UK notified the European Union (EU) of its intention to withdraw from the EU. From 1 May 2017 to 31 January 2020, preparation for Brexit and redistribution of the MHRA portfolio occurred. The UK formally left the EU on 31 January 2020.

A transition period began on 1 February 2020 and ended on 31 December 2020.

The MHRA retaining responsibility for granting Marketing Authorization across the United Kingdom

The Medicines and Healthcare Products Regulatory Agency (MHRA) retains responsibility for granting Marketing Authorization across the United Kingdom. Great Britain (also sometimes called mainland UK) comprises England, Scotland, and Wales. Northern Ireland is on the island of Ireland with the Republic of Ireland (Ireland).

The MHRA is now the sole decision-maker regarding the authorisation of medicines and medical devices in the UK, except for decisions on marketing authorisation applications (MAAs) made through the European procedures to market products in Northern Ireland such as Centrally Authorised Products (CAPs) via the EMA. This means that the marketing authorisations (MAs) issued by the MHRA for novel products will be valid only for Great Britain (England, Wales, and Scotland).

The grandfathering process allowed all existing Centrally Authorised Procedure (CAP) MAs to automatically convert into UK MAs effective in Great Britain (England, Scotland and Wales only). Those UK MAs were issued a new MA number on 1 January 2021 (with a PL GB format) unless MAHs advised the MHRA otherwise.

New Marketing Authorisation Application Procedures for the UK

From 1 January 2021, Market Authorisation types are possible in the United Kingdom (UK) in three ways. One is PL – authorised for use in the United Kingdom as a purely national UK-wide MA or as part of an MR/DC procedure involving Northern Ireland as CMS, but a UK-wide MA. Second is PLGB – authorised for use in Great Britain only (England, Scotland and Wales); as a purely Great Britain national or following conversion of a centrally authorised product (CAP) or under the unfettered access route (MAH needs to be established in Northern Ireland and any product must access Great Britain, via Northern Ireland as a qualifying Northern Ireland good). Third is PLNI – authorised for use in Northern Ireland only, as a purely Northern Ireland national or part of an MR/DC procedure including Northern Ireland.

MHRA Guidance on handling Decentralised and Mutual Recognition Procedures

Medicines and Healthcare Products Regulatory Agency has given a choice to MA holders or Applicants on managing their marketing authorisations/applications, such as converting PL-wide licenses into PLNI and PLGB or vice-versa.

MHRA guidance on handling Decentralised and Mutual Recognition Procedures, which are approved or pending, excludes products already subject to an EU Community Marketing authorisation in Northern Ireland or that fall within the mandatory scope of the EMA’s centralised procedure. Hence, it does not apply to any GB MA approved through the European Community Decision Recognition Procedure (ECDRP) or converted EU Marketing authorisations (grandfathered products).

Timelines and Procedures for converting PLGB and PLNI licenses

The timelines for the completion of the process are 42 days for MA-granted cases and the conversion of pending applications at the end of the procedure; these will be completed within the 30-day national phase.

When submitting a conversion of a PLGB license into a PLNI or PL license, MAHs must select the regulatory activity, ‘Territory change’ and ‘Original submission’ for regulatory sub-activity for submissions via MHRA Submission Portal.

The documents must be submitted using the next sequence number in the original PLxx dossier in eCTD format. ‘PL Number Generation’ is opted in MHRA Submission Portal after registration. It is important to mention which license will be changed to the PL number if a PLGB and a PLNI license are held for the same product. Once the PL number is assigned, the Summary of Product Characteristics (SmPC) for each strength and pharmaceutical form in Microsoft Word format and Patient Information Leaflet (PIL) and Label with new PL number are to be submitted within the eCTD submission via the MHRA Submission Portal.

In case of an application which is in the initial stage and not yet approved, the change of PLGB / PLNI number to a PL number should be discussed with the assessment team and at the end of the procedure stage, the replacement PL number supplied in the cover letter confirming the change of prefix. Within six months of approval of the conversion, updated packaging is implemented.

Implementation timelines for updated packaging and subsequent PIQ applications

In case of approved MA, a subsequent PIQ application (only QRD text) must be submitted under Regulation 267 of the Human Medicines Regulations 2012 (change code P1) before marketing the product using the PL number. In addition, a justification must be provided in the Cover Letter. The implementation timeline for updated packaging is six months.

ProductLife Group’s capabilities and support for UK licenses and Pharmacovigilance

Product Life Group has the capabilities to guide you and carry out the conversion of a Great Britain License (PLGB) or Northern Ireland License (PLNI) to a UK-wide PL License, which are already the subject of an EU Community Marketing authorisation in Northern Ireland or which fall within the mandatory scope of the EMA’s centralised procedure. In addition, PLG experts can provide you with end-to-end support for UK licenses.

You can request PLG’s assistance while registering your product in the UK, dossier preparation, variation categorisation and life-cycle management in the UK. Also, PLG can help you to transfer your EU / US / other international market data to the UK.

Further to this, PLG can support you on the approach to United Kingdom pharmacovigilance by rendering services to establish a national contact person for pharmacovigilance (where QPPV is not in the UK), UK and non-UK Individual Case Safety Reports (ICSRs), Signal management, Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs), Post-Authorisation Safety Studies (PASS) protocols and final study reports. In addition, we extend our service in case of implementing outcomes of EU safety referrals.