Supply of authorised medicines to Northern Ireland

Medicines for the Northern Ireland market must follow the EU acquis in accordance with Annex 2 of the Northern Ireland Protocol with a pragmatic approach to applying EU rules on importation and unique identifier requirements. This 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.

If batch testing and QP certification is done in Great Britain (England, Wales and Scotland), medicines with a valid marketing authorisation can be supplied to Northern Ireland. If batch testing and QP certification is done in the EU/EEA, medicines can be supplied to Northern Ireland via Great Britain.

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.

There are alternative supply chain options for Northern Ireland. These include:

• Useuse of the Common Transit Convention when transporting goods via Great Britain
• Routingrouting Northern Ireland logistics directly from the EEA

As the serialisation requirements of EU Delegated Regulation 2016/161 continue to apply in Northern Ireland, medicines with a marketing authorisation valid in Northern Ireland (PL and PLNI) require a unique identifier and a tamper evident device on each pack.

The unique identifiers on packs with a marketing authorisation that is valid in Northern Ireland (PL and PLNI) and supplied by a manufacturer or wholesaler in the EEA, do not require decommissioning by them as exported packs when supplied to GB until the31 31st December 2024. Unique identifiers on these packs should however, be decommissioned in Northern Ireland, as required by EU Delegated Regulation 2016/161.

Medicines with a marketing authorisation valid only in Great Britain (England, Wales and Scotland) labelled as PLGB do not require a Unique Identifier. However, we encourage companies to retain the tamper evident device. PLGB medicines must not be supplied to Northern Ireland unless specifically approved by DHSC and the MHRA via the Northern Ireland MHRA Authorised Route (NIMAR).

Identification of medicines authorised for supply in Northern Ireland

Wholesale distributors in Great Britain have reported challenges in consistently identifying whether a product is authorised for sale or supply in Northern Ireland while both Centrallycentrally Authorisedauthorised Productsproducts (CAPs) and PL packaging presentations remain available in the market as well as the PLGB.

ItThe isMHRA recognisedrecognises that the supply chain requires practical guidance on the actions to be taken if PLGB products are inadvertently supplied to Northern Ireland.

Wholesalers aremust required to have controls in place to ensure the correct product is picked and sent to customers and that it is authorised for sale or supply in Northern Ireland.  ItIt is expected that wholesalers’ procedures are implemented in ways designed to ensure medicines are not supplied unless authorised for sale or supply in Northern Ireland.

Where a wholesaler has identified that a PLGB has been incorrectly supplied to Northern Ireland, the wholesaler must perform an investigation to ensure the incident is recorded and corrective and preventative actions (CAPA) are made. Failure to implement and maintain an effective system for supply to Northern Ireland may be identified as a Goodgood Distributiondistribution Practicepractice (GDP) deficiency as set out in guidance on inspections.inspections.

As a transitional position, where it is clear that the supply of a PLGB has been made by a wholesaler in genuine error, the MHRA will deal with this without the need for enforcement action. In the event that any of these arrangements change, the MHRA will seek to provide reasonable notice to enable businesses and citizens to make appropriate preparations.

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, referenceyou should also berefer 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.

There are issues regarding ephedrine and pseudoephedrine containing medicinal products which fall within the definition of ‘Category 4’ Drugdrug Precursorprecursor Chemicals.chemicals. Trade between GB and NI will be subject to licensing in accordance with the requirements in Precursorprecursor chemical export and import authorisation. See Home Office guidance on precursor chemical licensing.

Contact

For further information, please email our Customer Services Centre at info@mhra.gov.uk or call 020 3080 6000. Alternatively, contact your Tradetrade Association by emailing:association.

• Association