These Regulations amend the Human Medicines Regulations 2012 (“the 2012 Regulations”), which govern the arrangements, across the United Kingdom, for the licensing, manufacture, wholesale dealing and sale or supply of human medicines for human use.

Subject to various exceptions, medicines for human use may only be sold or supplied if they have been granted a marketing authorisation by the licensing authority (which is either, or both, of the Secretary of State and the Minister of Health in Northern Ireland). One of those exemptions is found in regulation 167 (supply to fulfil special patient needs), originally deriving from Article 5(1) of Directive 2001/83/EC of the European Parliament. This provides a tightly governed route to lawfully supply unlicensed medicines. In order to have a means of lawful supply of prescription only medicines to Northern Ireland from Great Britain, new regulations 167A and 167B introduce a new exemption that also derives from Article 5(1) (regulation 14). This exemption, or route, is called the Northern Ireland MHRA authorised route (‘NIMAR’) (regulation 4). Products supplied to Northern Ireland using this route are classified in Northern Ireland as a prescription only medicine (regulations 3 and 14).

There are two methods by which listed NIMAR products may find their way to clinicians in Northern Ireland, either directly from marketing authorisation holders and wholesale dealers based in Great Britain or via wholesale dealers based in Northern Ireland. Amendments provide that a holder of a wholesale dealer’s licence can lawfully supply listed NIMAR products to Northern Ireland (regulation 5). Amendments also provide appropriate governance, such as new regulation 43ZA, which sets out the obligations that are placed on holders of wholesale dealer’s licences in Great Britain supplying listed NIMAR products to Northern Ireland (regulation 11). Regulation 12 also ensures that responsible persons in Northern Ireland verify whether products are or are not supplied into Northern Ireland in accordance with NIMAR. Governance of those with manufacturer’s licence is provided (regulations 6, 7, 8, 9, 10, 24, 25 and 26).

Part 11 of the 2012 Regulations contain provisions relating to pharmacovigilance. Amendments have been made to ensure that marketing authorisation holders in Great Britain are under an obligation to record and report adverse reactions that occur in Northern Ireland that they are made aware of (regulations 15 and 16).

Prescription only medicines may only be sold or supplied in accordance with a prescription of, or administered parenterally by, a health care professional who is classed as an appropriate practitioner. The 2012 Regulations already provide for either or both of these Part 12 restrictions to be set aside by instruments known as Patient Group Directions (PGDs). Amendment have been made to ensure that what can be done by way of PGDs can include listed NIMAR products (regulations 17 to 22).

The review provision in the 2012 Regulations has also been modified to take account of these Regulations (regulation 23).

A full Impact Assessment has not been produced for this instrument as it is not expected to have a significant impact on the public or voluntary sectors and only minimal impact on the private sector is foreseen. A Regulatory Triage Assessment of the effect that this instrument will have on the costs of business and the voluntary sector has been produced. The Explanatory Memorandum is published alongside these Regulations on www.legislation.gov.uk.