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).

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).

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. For more information, see guidance on UK-wide licensing for human medicines.

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.

Medicines outside this scope (which can already be authorised as UK-wide MAs), will be designated as ‘Category 2’. For more information on Category 1 and Category 2 products, see guidance on UK-wide licensing for human medicines.

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.

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. See: Internal Market Movements from Great Britain to Northern Ireland - GOV.UK.

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.

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.

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.

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.

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.

Home Office controlled drug import-export licensing requirements for trade in controlled drugs within the UK will not change.

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.

See the list of the controlled drugs most enquired about. The list is not exhaustive and, in the event of a substance not being listed, reference should also be made to the 1971 Act and the 2001/2002 Regulations at legislation.gov.uk.

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.

See guidance on how to apply for a Home Office controlled drug import-export licence for trade in controlled drugs from the UK.

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. See Home Office guidance on precursor chemical licensing.

Contact

For further information, email our Customer Services Centre at info@mhra.gov.uk or call 020 3080 6000. Alternatively, contact your trade association.

Supplying authorised medicines to Northern Ireland