A combination of newly released and recently updated guidance from the Medicines and Healthcare products Regulatory Agency (MHRA) clarifies the requirements and procedures for the importing of medicines and devices into Northern Ireland (NI) following the end of the transition period.
Guidance on the application of the European Union Medical Device Regulation (EU MDR) and In Vitro Diagnostic Regulation (IVDR) to the NI market has been updated with a new section on importer requirements. An importer is defined as “any natural or legal person established within the Union that places a device from a third country on the Union market”. There are several legal obligations importer must meet and these relate to the registration, labelling and conformity declaration of the device.
Additionally, a related guidance document on the Northern Ireland Protocol (which details the supply of devices from Great Britain to NI) has been updated to include a section on customs requirements. Included are details on the Trader Support Service to guide suppliers on any relevant changes due to the implementation of the Protocol.
Following an earlier European Commission (EC) notice on the application of Brexit legislation on markets historically dependent on medicines supplied from or through Great Britain (GB), the MHRA has recently released guidance that pertains to the importing of medicines into NI. The guidance is based on the EC notice which allows for regulatory flexibilities when importing into NI, products approved in the UK.
For products approved in the UK before 31 January 2021, all UK licensed medicines within a company’s portfolio will make use of these regulatory flexibilities. For all new products approved in the UK after 31 January 2021, and before 31 December 2021, these regulatory flexibilities will automatically apply. In both scenarios, the MHRA must be informed of each medicine which will not make use of these flexibilities.
For new product applications via the decentralised procedure (DCP) or mutual recognition procedure (MRP) with UK (NI) as a Concerned Member State (CMS), the regulatory flexibilities allow each batch of a medicinal product to be tested and released by a UK based Qualified Person (QP) until 31 December 2021.
To view the full guidance on importing medicines into NI, click here.