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Explanatory note

Original text. Later amendments are not shown.

(This note is not part of the Order)

This Order makes amendments to—

(a)

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; and

(b)

the Medicines (Pharmacy and General Sale—Exemption) Order 1980 (“the Pharmacy and General Sale Order”) which provides for exemptions from sections 52 and 53 of the Medicines Act 1968 (restrictions on the sale or supply of medicinal products).

Article 2 amends the POM order to remove an obsolete definition.

Article 3 amends the POM Order to enable a pharmacist to make an emergency sale or supply of a prescription only medicine at the request of a dentist who is unable to furnish a prescription immediately and to make an emergency sale or supply of a quantity of a prescription only medicine, except in the case of certain controlled drugs, sufficient to provide up to 30 days’ treatment to a person requesting the pharmacist to supply in the absence of a prescription from certain appropriate practitioners. It also amends the POM Order so that in the event of, or anticipation of, a pandemic disease which poses a serious threat to human health, a pharmacist need only satisfy himself that the person who is to be treated with a prescription only medicine has been prescribed that medicine before and that the dosage of that medicine is appropriate for that person.

Articles 4 and 5 amend the POM Order and Pharmacy and General Sale Order respectively to provide for the supply of a medicinal product during a pandemic in accordance with a protocol approved by the Secretary of State and Minister for Health, Social Services and Public Safety, or by an NHS body for the purpose of treating a pandemic disease which is a serious risk to human health or potentially a serious risk to human health.

An Impact Assessment has been prepared in respect of this Order which is available from the Medicines and Healthcare products Regulatory Agency, Market Towers, 1 Nine Elms Lane, London SW8 5NQ.