Under the Northern Ireland protocol (NIP), medicines moving from Great Britain to Northern Ireland are required to comply with the EU pharmaceutical acquis. This creates a number of additional and duplicative regulatory barriers which risk the continuity of supply for medicines moving into NI.
Negotiations are under way to seek a bilateral agreement with the EU to tackle these problems. In order to support this, it is essential that we do everything we can to ensure that our regulations are fit for purpose, regardless of the outcome of these negotiations, and that the supply of medicines to patients in Northern Ireland is not put at risk.
The Medicines and Healthcare products Regulatory Agency (MHRA), and officials from my own Department for Health and Social Care (DHSC), have been working closely with officials from the Northern Ireland Department of Health (DHNI) in recent months to design a robust contingency measure which can be operational, if necessary, to support the flow of medicines into Northern Ireland from 1 January 2022.
Today the UK Government will be introducing a statutory instrument titled the Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 to establish the Northern Ireland MHRA Authorised Route (NIMAR).
NIMAR provides a route for the lawful supply of prescription only medicines that are unlicensed in NI, where no licensed alternative is available. This route will be tightly governed, with all medicines supplied via NIMAR already complying with the strong regulatory safeguards required for a product to enter the GB market. All medicines supplied this way into Northern Ireland will meet the MHRA’s robust standards that are in place for the rest of the UK.
Supply using the NIMAR route will be closely monitored by DHSC, in partnership with officials at DHNI. It will only be used where clinical need cannot be met by a licensed alternative, in the interests of public health.
It will allow citizens in NI to continue to access the prescription only medications that they require for their individual treatment.
The required statutory instrument will be laid before the house today, along with the accompanying explanatory memorandum, and I invite members to refer to this for more detail on the functionality and detail of NIMAR.