1. Supply of authorised medicines to Northern Ireland

Medicines for the Northern Ireland market must follow the EU acquis as per 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 draft EU Unilateral Declaration in the Withdrawal Agreement Joint Committee.

Batch testing and QP certification will continue to be required to place a product on the UK market as per the requirements detailed in regulation 41(2) of the Human Medicines Regulations 2012.

Batch testing and QP certification done in Great Britain (England, Wales and Scotland) will enable supply of medicines with a valid marketing authorisation to Northern Ireland. Batch testing and QP certification done in the EU/EEA will also enable supply to Northern Ireland via Great Britain (including packs not moved under transit procedures using the Common Transit Convention).

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 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 EEA

The serialisation requirements of EU Delegated Regulation 2016/161 will continue in Northern Ireland. Medicines 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 valid in Northern Ireland (PL and PLNI) supplied by a manufacturer or wholesaler in the EEA will not require decommissioning when exported to the UK until the 31st December 2024. Unique identifiers on these packs should 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 will not require a Unique Identifier. However, we encourage companies to retain the tamper evidence device. PLGB medicines must not be supplied to Northern Ireland unless specifically approved by MHRA.

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’) and the Misuse of Drugs Regulations 2001 (‘the 2001 Regulations’).

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

• Association of the British Pharmaceutical Industry (ABPI): regulatory@abpi.org.uk
• British Generic Manufacturers Association (BGMA): info@britishgenerics.co.uk
• BioIndustry Association (BIA): regulatory@bioindustry.org
• Clinical & Contract Research Association (CCRA): mail@ccra.org.uk
• Ethical Medicines Industry Group (EMIG): info@emig.org.uk
• Health Food Manufacturers’ Association (HFMA): pennyviner@btconnect.com
• The National Pharmacy Association (NPA): independentsvoice@npa.co.uk
• Proprietary Association of Great Britain (PAGB): regulatory@pagb.co.uk