Explanatory note

This Order makes further amendments to certain Orders relating to the administration and sale or supply of medicines for human use.

Articles 2 to 5 amend the Prescription Only Medicines (Human Use) Order 1997 (“the POM Order”) which specifies the description and classes of medicines (“prescription only medicines”) which may be sold or supplied only in accordance with the prescription of an “appropriate practitioner” and may be administered only by or in accordance with the directions of such a practitioner. Article 12D of the POM Order provides an exemption for the supply (otherwise than by retail sale) and administration of prescription only medicines by designated health professionals in the course of the business of an independent hospital, clinic or agency in accordance with a Patient Group Direction. Article 12C of the POM Order makes provision for a person conducting a retail pharmacy business to supply (otherwise than by retail sale) or administer prescription only medicines under an arrangement with specified bodies, including those specified under article 12D.

Articles 2 and 4 of this Order extend the exemption to include independent hospitals, clinics and agencies in Northern Ireland. Articles 2 to 5 of this Order also extend the exemptions to cover the retail sale of medicinal products in accordance with a Patient Group Direction, by, or under arrangements made by a retail pharmacy with, an independent hospital, clinic or agency.

Articles 6 to 8 amend the Medicines (Pharmacy and General Sale—Exemption) Order 1980 (“the Pharmacy and General Sale Order”) which provides exemptions from sections 52 and 53 of the Medicines Act 1968 (restrictions on sale or supply of medicinal products). Article 4C of the Pharmacy and General Sale Order makes provision for a person conducting a retail pharmacy business to supply, otherwise than by retail sale, prescription only medicines under an arrangement with specified bodies, including independent hospitals, clinics and nursing homes. Articles 6 and 7 of this Order amend articles 1 and 4C to extend the exemption to include independent hospitals, clinics and medical agencies in Northern Ireland. Articles 6 to 8 also make provision for the retail sale of medicinal products in accordance with a Patient Group Direction.

A full regulatory impact assessment of the effect that this instrument will have on the costs of business is available from the Medicines and Healthcare products Regulatory Agency, Market Towers, 1 Nine Elms Lane, London SW8 5NQ. Copies of the assessment have been placed in the libraries of both Houses of Parliament.