The Medicines for Human Use (Prescribing) Order 2005

Explanatory Note

(This note is not part of the Regulations)

Article 2 of this Order creates a new exemption to the restrictions imposed by sections 7 and 8 of the Medicines Act 1968 (general provisions as to dealing with medicinal products and provisions as to manufacture and wholesale dealing). It provides that the restrictions imposed by those sections shall not apply to the preparation or dispensing or to procuring the preparation or dispensing of a medicinal product for human use in accordance with a presciption given by a supplementary prescriber where this is done by or under the supervision of a pharmacist in a registered pharmacy, hospital or health care centre or, in Scotland, in a care home service.

The remainder of this Order further amends 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 in accordance with the directions of such a practitioner.

Article 3 amends article 2 of the POM Order to extend the definition of “supplementary prescriber” to include chiropodists and podiatrists, physiotherapists and diagnostic or therapeutic radiographers.

Article 4 amends article 3B of the POM Order to remove the restriction in sub-paragraph (3)(b) of that article which provides that supplementary prescribers may only prescribe prescription only medicines in respect of which a product licence, marketing authorisation or homeopathic certificate of registration is in place, or other prescription only medicines only where the medicine is to be administered in the course of a clinical trial.

Article 5 amends article 13A of the POM Order. Paragraph (1) of article 13A provides that the restrictions on sale or supply of prescription only medicines shall not apply to the sale or supply of a prescription only medicine by a pharmacist in accordance with a prescription given by person of a type listed in the paragraph where the listed person is not, but the pharmacist on reasonable grounds believes him to be, an appropriate practictioner in relation to that medicine. The listed persons are those professionals who may be supplementary prescribers. To accord with the amendments to the revised definition of “supplementary prescriber”, this amendment adds chiropodists and podiatrists, physiotherapists and diagnostic or therapeutic radiographers to that list.

Article 6 substitutes a new Article 15 of the POM Order. Article 15 was amended by the Prescription Only Medicines (Human Use) (Electronic Communications) Order 2001(1).Paragraph 2 of the new Article replicates existing provisions. Paragraphs 3 and 4 of the new Article substitutes new provisions which provide that a prescription, other than one given by a veterinary surgeon or practitioner, or for a controlled drug specified in Schedule 1, 2 or 3 of the Misuse of Drugs Regulations, does not have to be signed and written in ink if it is created in electronic form and signed with an advanced electronic signature and transferred to the person by whom it is dispensed as an electronic communication.

Article 7 makes changes to the list of prescription only medicines, in Schedule 3A of the principal Order, which may be prescribed by extended formulary nurse prescribers.

Article 8 makes changes to the list of prescription only medicines which may be sold or supplied by a registered pharmacist on receipt of an order signed by a registered opthalmic optician, or which may be sold or supplied by a registered opthalmic optician directly in the course of his professional practice in an emergency.

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

(1)

S.I..2001/2889.