The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2006

EXPLANATORY NOTE

(This note is not part of the Order)

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

Articles 2 to 4 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 2 amends article 1 of the POM Order and article 3 inserts a new article 7B in order to create an exemption from the requirement that a prescription only medicine may only be administered by an appropriate practitioner or a person acting in accordance with his directions. In particular article 3 makes provision for persons who are operators under the Ionising Radiation (Medical Exposure) Regulations 2000 (“the IRME Regulations”) to administer radioactive medicinal products or other prescription only medicines administered in connection with medical exposures under those Regulations. The operator must be acting in accordance with the relevant procedures and protocols under the IRME Regulations. In addition, the operator must be acting under the authorisation of, or in accordance with the written guidelines of, a person who is a practitioner under the IRME Regulations and the holder of a certificate under the Medicines (Administration of Radioactive Substances) Regulations 1978.

Article 2(c) makes an amendment to the definition of “medicinal product” consequential on the amendments made to the Medicines Act 1968 by Schedule 8 to the Veterinary Medicines Regulations 2006(1). Those Regulations amend the Act so that it no longer applies to veterinary medicinal products.

Article 4(2) and (4) amends Parts I and III of Schedule 5 to the POM Order (exemption for certain persons from section 58(2) of the Act) to extend the list of prescription only medicines which may be sold or supplied or administered by chiropodists and podiatrists in the course of their professional practice.

Articles 4(3) and 5(3) amend Part II of Schedule 5 to the POM Order and Part II of Schedule 1 to the Medicines (Pharmacy and General Sale—Exemption) Order 1980 (“the Pharmacy and General Sale Order”), respectively. These articles create exemptions for persons holding a certificate in first aid from the Mountain Rescue Council of England and Wales or the Northern Ireland Rescue Co-ordinating Committee, to enable them to supply pharmacy and general sale list medicines or prescription only medicines for the treatment of sick or injured persons.

Article 5(2) amends Part I of Schedule 1 to 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 5(2) extends the list of medicines which may be sold or supplied by chiropodists and podiatrists in the course of their professional practice.

Articles 4(2)(a) and (4)(a) and 5(2) also make amendments consequential on earlier amending Orders.

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.

(1)

S.I. 2006/2407.