The MHRA has provided updated and new Brexit guidance on imports of medicines.
Import a human medicine (updated 20 October)
This guidance has been updated to include new information around Northern Ireland.
The guidance is part of Get UK customs clearance when importing goods from outside the EU: step by step and includes advice on importing licensed or unlicensed medicines, how to make an urgent import notification, information on medicines the MHRA would normally object to import and the supply of unlicensed medicines between Northern Ireland and GB after January.
Importing IMPs into GB from approved countries from 1 January (updated 20 October)
The update contains new information for Northern Ireland.
Sponsors of UK clinical trials importing IMPs into GB from outside the UK will need to review their existing supply chains.
Where the product is sourced from a country on the ‘approved country for import list’, this will include a UK Manufacturing and Import Authorisation (MIA(IMP)) holder putting in place an assurance system to check these IMPs have been certified by a Qualified Person (QP) in a listed country, before release to trial sites. The list of approved countries will initially include all EU and EEA countries.
IMPs imported into GB from outside the UK that have been QP certified in a listed country will not require re-certification in GB.
Further information is available here on:
- Import of IMPs from an approved country
- Oversight process
- Supply of IMP to GB clinical trial site
- Reference and retention samples
- Importing non-IMP for use in a clinical trial
Sourcing medicines for the GB market from an approved country for import or Northern Ireland from 1 January (updated 20 October)
This guidance describes the actions to take for sourcing medicines in different circumstances and has been updated to include new information around Northern Ireland.
- Importing medicines from an EEA State on the approved country for import list
- Importing UK or GB authorised medicines from a country on the list for use in GB
- Importing medicines from a country on the list for use as a special medicinal product
Importing medicines from a country on the list for export as an introduced medicine.
Acting as a Responsible Person (import) from 1 January (updated 20 October)
From 1 January 2021, a wholesale dealer in GB may only import Qualified Person (QP) certified medicines from the European Economic Area (EEA) if certain checks are made by the ‘Responsible Person (import) (RPi)’. Great Britain is England, Wales and Scotland.
This is permitted under the supervision of a Responsible Person (RP).
This guidance describes:
- how to apply to be an RPi,
- how to verify that QP certification of a medicine has been done in the EEA
- how to verify that biological products (vaccines and medicines derived from human blood or plasma) have an independent batch release certificate
RPi applications may be submitted through the MHRA Portal from 1 January 2021.
Medicinal products sourced from Northern Ireland for wholesale purposes are out of scope of this guidance. This is permitted under the supervision of a Responsible Person (RP). Products with a UK or GB MA that are imported into GB from outside the UK without QP certification from a country on the list will require QP certification under a UK manufacturing and import authorisation before being placed on the market.
Products without a marketing authorisation in the UK, Northern Ireland, Great Britain or a listed country are outside the scope of this guidance. Importation of such products is permitted under the supervision of a Responsible Person (RP), with notification to the MHRA of each importation that is for supply to the GB market.
Supplying medicines to Northern Ireland from 1 January (updated 20 October)
The content of this guidance covers
- Medicines placed on the market before 11pm on 31 December
- Checks require prior to sale or supply into Northern Ireland to confirm medicines were placed before the 31 December deadline
It will be further updated in due course to include all aspects of supplying medicines to NI from 1 January 2021.