Maintain your compliance in Northern Ireland

Since the beginning of 2021, medicines placed in Northern Ireland have come under different obligations than the rest of the UK. The Medicines and Healthcare products Regulatory Agency (MHRA) have released guidance on product information requirements for medicines marketed in the UK, including Northern Ireland.

UK Marketing Authorisation types

There are several different Marketing Authorisations (MA) application procedures:

Centralised Procedures

Under this category fall all the products that were approved by the European Medicines Agency (EMA). All existing Centrally Approved Products (CAP) MAs are being automatically converted into UK MAs, effective in Great Britain only. As a result of the Northern Ireland Protocol, existing CAPs remain valid in NI.
The European Commission Decision Reliance Procedure (ECDRP) currently allows CAPs to gain a GB MA as soon as possible after the European Commission approval.

Decentralised and Mutual Recognition Procedures​ (MRP/DCP/MRDCRP)

Northern Ireland can continue to be included in MR/DC procedures as a Concerned Member State (CMS). Marketing Authorisations approved through these procedures are effective in NI only. The MR/DC Reliance Procedure facilitates the application for UK-wide or GB-only MAs.

National Procedures​

MAs authorised through the National Procedure by the MHRA before 1st Jan 2021 continue to have effect across the UK (both Great Britain and Northern Ireland)​. Under this procedure the MHRA can grant MAs for UK, GB or NI.

Unfettered Access Procedures (UFA)

The UFA procedure for MAs approved in NI allows the MHRA to grant GB MA approval for an existing MA that covers Northern Ireland. This is available to NI MAs approved via centralised or MR/DC procedures.

UK Marketing Authorisation Numbers​

There will be three types of Marketing Authorisation numbers​:

• PL - National UK wide MA​. Example: PL 12345/6789​
• PLGB - Great Britain only: England, Scotland, Wales. Example: PLGB 12345/6789
• PLNI / EU​ - Northern Ireland only and Centrally Approved Products valid in NI. Example: PLNI 12345/6789 or EU/1/23/456/001.

UK MA renewals

The requirements for renewal remain the same for products authorised in the UK and should include the same documents currently required in the EU.
SmPC and PIL documents - The structure of Northern Ireland SmPC and PIL documents remains the same​.

How to maintain your compliance for Northern Ireland

emc customers can publish any Summary of Product Characteristic (SmPC), Patient Information Leaflet (PIL) or Risk Minimisation Material (RMM) that is Northern Ireland specific. We released a new subscription service that facilitates the submissions and publication of Northern Ireland documents.

If you would like to know more about publishing safety information relevant for Northern Ireland by using this service, please contact us.