Supplying Authorised Medicines to Northern Ireland Under the Windsor Framework

1. Overview

Since 1 January 2025, the MHRA has regulated most medicines through UK-wide marketing authorisations (MAs). UK-wide MAs applied for on or after this date will have an MA number with a PL prefix. Medicines applied for or authorised UK-wide before that date under an MA number with a PLGB prefix will retain that number (including the PLGB prefix). https://www.gov.uk/guidance/supplying-authorised-medicines-to-northern-ireland MAs covering only Northern Ireland (NI MAs) have a PLNI prefix. These medicines can continue to be supplied to Northern Ireland (NI) after 1 January 2025. However, new NI MA applications can only be made via the EU mutual recognition procedure or decentralised procedure (MRP/DCP). https://www.gov.uk/guidance/supplying-authorised-medicines-to-northern-ireland Marketing authorisation holders (MAHs) have not been able to apply for a MA covering only Great Britain (GB MA) since 31 December 2024. The MHRA retains the right to issue GB MAs after 1 January 2025, but this will not be available through application. They will be issued only in exceptional circumstances to safeguard the interests of patients’ health in the UK. https://www.gov.uk/guidance/supplying-authorised-medicines-to-northern-ireland

2. Supply of Authorised Medicines to Northern Ireland

From 1 January 2025, Union authorisations issued by the European Commission have ceased to be valid for Northern Ireland. Since then, medicines that were previously within the scope of the EU centralised procedure have been authorised under UK-wide MAs and are no longer limited in territorial scope as GB MAs. These products will be designated in line with definitions in UK law as ‘Category 1’. Category 1 includes the generic, hybrid or biosimilar products of Category 1 reference products. https://www.gov.uk/guidance/supplying-authorised-medicines-to-northern-ireland Medicines outside this scope (which can already be authorised as UK-wide MAs) will be designated as ‘Category 2’. https://www.gov.uk/guidance/supplying-authorised-medicines-to-northern-ireland Medicines for the Northern Ireland market in Category 2 must follow relevant EU law in accordance with Annex 2 of the Windsor Framework. The approach to importation rules is as set out in the Directive (EU) 2022/642 which amends Directives 2001/20/EC and 2001/83/EC as regards derogations concerning certain medicinal products for human use made available in the United Kingdom in respect of Northern Ireland. https://www.gov.uk/guidance/supplying-authorised-medicines-to-northern-ireland Medicines can be supplied from the Great Britain market to Northern Ireland without requiring additional regulatory importation controls (manufacture and import authorisation, batch testing and QP certification done in Northern Ireland or an EEA state). This means wholesale dealers can supply medicines from Great Britain to Northern Ireland. As with all goods, medicines being moved from Great Britain to Northern Ireland will still need to be declared for customs purposes or moved using the simplified processes being introduced under the Windsor Framework. https://www.gov.uk/guidance/supplying-authorised-medicines-to-northern-ireland EEA packs procured by organisations in Northern Ireland featuring unique identifiers should be decommissioned prior to supply to Northern Ireland, as required by EU Delegated Regulation 2016/161 if intended for the UK market. For goods intended to be traded within the EEA market, these goods do not require decommissioning. https://www.gov.uk/guidance/supplying-authorised-medicines-to-northern-ireland

3. Identification of Medicines Authorised for Supply in Northern Ireland

Medicines compliant with licensing and packaging requirements under the Windsor Framework may be freely circulated through the United Kingdom. Non-compliant legacy packs QP certified prior to 1 January 2025 may continue to be supplied within the UK in the territories for which they were authorised in accordance with the regulations. https://www.gov.uk/guidance/supplying-authorised-medicines-to-northern-ireland Since 1 January 2025, any medicine labelled with MA number with a PLGB prefix is valid UK-wide. If, in future the MHRA issues a MA valid only in Great Britain, this guidance will be updated accordingly. Medicines labelled with PLNI numbers are authorised by the MHRA for sale and supply in Northern Ireland only. https://www.gov.uk/guidance/supplying-authorised-medicines-to-northern-ireland

4. Licensing Requirements for Medicines Containing Controlled Drugs

There will be no changes to licensing requirements for medicines containing controlled drugs. This is covered by UK legislation. https://www.gov.uk/guidance/supplying-authorised-medicines-to-northern-ireland Controlled drugs are controlled in the UK under the Misuse of Drugs Act 1971 (‘the 1971 Act’), the Misuse of Drugs Regulations 2001 (‘the 2001 Regulations’), and the Misuse of Drugs Regulations (Northern Ireland) 2002. https://www.gov.uk/guidance/supplying-authorised-medicines-to-northern-ireland Home Office controlled drug import-export licensing requirements for trade in controlled drugs within the UK will not change. https://www.gov.uk/guidance/supplying-authorised-medicines-to-northern-ireland Home Office controlled drug import-export licensing requirements for trade in controlled drugs from the UK, including from Northern Ireland, to the EU, and vice versa, will not change. https://www.gov.uk/guidance/supplying-authorised-medicines-to-northern-ireland There are no new licensing requirements under the 1971 Act for companies moving medicines containing controlled drugs from Great Britain to Northern Ireland as a result of the Protocol. https://www.gov.uk/guidance/supplying-authorised-medicines-to-northern-ireland Medicinal products containing ephedrine and pseudoephedrine fall within the definition of ‘Category 4’ Drug Precursor Chemicals. As such, trade between GB and NI will be subject to licensing in accordance with the requirements in Precursor chemical export and import authorisation. https://www.gov.uk/guidance/supplying-authorised-medicines-to-northern-ireland

5. Updates and Transitional Arrangements

Last updated 9 June 2025. Updates include: Added new overview section. Updated sections to reflect the implementation of the Windsor Framework on 1 January 2025. Added information confirming medicines moved from Great Britain to Northern Ireland must be declared for customs or moved using the Windsor Framework simplified processes. Previous updates on post-Brexit protocols and guidance revisions. https://www.gov.uk/guidance/supplying-authorised-medicines-to-northern-ireland