Guidance

Supplying authorised medicines to Northern Ireland

What you need to do to supply authorised medicines from Great Britain to Northern Ireland.

From:
Medicines and Healthcare products Regulatory Agency
Published
31 December 2020
Last updated
2223 DecemberJanuary 20212023 — See all updates

1. Supply of authorised medicines to Northern Ireland

Medicines for the Northern Ireland market must follow the the EU acquis acquisin asaccordance perwith Annex 2 of the Northern Ireland Protocol with a pragmatic approach to applying applying EU rules rules on importation and unique identifier requirements. This is as set out in thethe Directive draft (EU) Unilateral2022/642 Declarationwhich inamends theDirectives Withdrawal2001/20/EC Agreement Joint Committee.

Batch testing and QP2001/83/EC certificationas willregards continuederogations toconcerning becertain requiredmedicinal toproducts placefor ahuman productuse onmade theavailable UKin market as per the requirementsUnited detailedKingdom in regulationrespect 41(2) of theNorthern Human Medicines Regulations 2012.Ireland.

BatchIf batch testing and and QP certification certificationis done in Great Britain (England, Wales and Scotland)Scotland), will enable supply of medicines with a valid marketing authorisation can be supplied to Northern Ireland. BatchIf batch testing and and QP certification certificationis done in the the EU/EEA, medicines willcan alsobe enablesupplied supply to Northern Ireland via Great Britain (including packs not moved under transit procedures using the Common Transit Convention).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 and QP certification certification done in Northern Ireland or an an EEA state). state). This means that wholesale dealers can continue to supply medicines from Great Britain to Northern Ireland.

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

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

TheAs the serialisation requirements of of EU Delegated Delegated Regulation 2016/161 will continue to apply in Northern Ireland.Ireland, Medicinesmedicines with a marketing authorisation valid in Northern Ireland (PL and PLNI) will 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 the EEA, do will not require decommissioning whenby them as exported topacks thewhen UKsupplied to GB until the 31st December 2024. Unique identifiers on these packs should however, be decommissioned in Northern IrelandIreland, as required by by EU Delegated Delegated Regulation 2016/161.

Medicines with a marketing authorisation valid only in Great Britain (England, Wales and Scotland) labelled as PLGB willdo not require a Unique Identifier. However, we encourage companies to retain the tamper evidenceevident device. PLGB medicines must not be supplied to Northern Ireland unless specifically approved byby 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 Centrally Authorised Products (CAPs) and PL packaging presentations remain available in the market as well as the PLGB.

It is recognised that the supply chain requires practical guidance on the actions to be taken if PLGB products are inadvertently supplied to Northern Ireland.

Wholesalers are 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.  It 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 Good Distribution Practice (GDP) deficiency as set out in guidance on 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’)Act’), and the Misuse of Drugs Regulations 2001 (‘the 2001 Regulations’).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 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 20012001/2002 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’ Drug Precursor Chemicals. Trade between between GB and  and NI will 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, please email our Customer Services Centre at info@mhra.gov.uk or call 020 3080 6000. Alternatively, contact your Trade Association by emailing:

Published 31 December 2020
Last updated 2223 DecemberJanuary 20212023 + show all updates

  1. Updates to the Supply of authorised medicines to Northern Ireland guidance.

  2. Update to post-Brexit protocols

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