The Prescription Only Medicines (Human Use) Amendment Order 2002

Explanatory Note

(This note is not part of the Order)

This Order amends the Prescription Only Medicines (Human Use) Order 1997 (“the principal Order”).

Articles 2, 3, 5 and 9 make provision for nurses meeting certain conditions (“extended formulary nurse prescribers”) to prescribe certain prescription only medicines. Article 2 amends article 1 of the principal Order, so as to insert definitions of “extended formulary nurse prescriber” and “district nurse/health visitor prescriber”, and makes changes consequential on the Nursing and Midwifery Order 2001 (S.I. 2002/253). Article 3 amends article 2 of the principal Order, so as to provide that such persons are “appropriate practitioners” for the purposes of section 58 of the Medicines Act 1968 (restrictions on sale and supply), as amended by section 63 of the Health and Social Care Act 2001. Article 5 inserts a new article 3A into that Order, which makes provision for prescribing by extended formulary nurse prescribers; in particular, for the descriptions and classes of product which they may prescribe and the conditions as to the cases or circumstances in which such a person may prescribe. Article 9 inserts Schedule 3A into that Order; the Schedule lists the substances which such persons are able to prescribe and the requirements which must be complied with in relation to each substance. Articles 6 and 8 make consequential amendments.

Articles 2(2)(h) and (i) and 10 make amendments consequential on the Health Professions Order 2001 (S.I. 2002/254), which makes provision for the regulation of certain health professions, including chiropodists, paramedics, orthoptists, physiotherapists and radiographers.

Article 4 amends article 3 of the principal Order (which specifies classes of products which are prescription only medicines) to provide that medicinal products which have been granted a United Kingdom or Community marketing authorization will be prescription only medicines if so classified in their marketing authorization. Medicinal products for which no marketing authorization has been granted will continue to be classified as prescription only if they contain a substance listed in column 1 of Schedule 1. Article 10 revokes articles 4 and 6 of the principal Order as a consequence of these changes.

Article 7 inserts article 13A into the principal Order, which provides for exemptions from the restrictions in section 58 of the 1968 Act (restrictions on sale and supply) in cases where a pharmacist supplies a medicinal product in accordance with a prescription by a nurse or midwife.

A Regulatory Impact Assessment in relation to this Order has been placed in the libraries of both Houses of Parliament and copies may be obtained from the Department of Health, Medicines Control Agency, Information Centre, Room 10-202, Market Towers, 1 Nine Elms Lane, London SW8 5NQ.