The Prescription Only Medicines (Human Use) Amendment Order 2000

Explanatory Note

(This note is not part of the Order)

This Order amends the Prescription Only Medicines (Human Use) Order 1997 (the principal Order) by substituting a revised article 12, and inserting new articles 12A, 12B, 12C and Schedule 7. These amendments provide for the following new exemptions from the restrictions in section 58(2) of the Medicines Act 1968—

(a) in article 12A, an exemption from section 58(2)(a) for the supply of a prescription only medicine by a specified national health service body, for administration in accordance with the patient specific directions of a doctor or dentist;

(b) in article 12A, an exemption from section 58(2) for the supply or administration of a prescription only medicine by a specified national health service body, where the product is supplied for the purpose of being administered, or is administered, by a designated health professional in accordance with a Patient Group Direction (i.e. a written direction providing for the supply and administration, or administration, of a description or class of prescription only medicine to persons generally), where the Direction is signed by a doctor or a dentist and by a pharmacist, and certain other conditions are satisfied;

(c) in article 12B, an exemption from section 58(2) for the supply or administration of a prescription only medicine by a designated health professional in order to assist a doctor or dentist in providing NHS services, where the product is supplied or administered in accordance with a Patient Group Direction, and the conditions referred to in (b) above are satisfied;

(d) in article 12C, an exemption from section 58(2) for the supply or administration of a prescription only medicine by a person lawfully conducting a retail pharmacy business under an arrangement with a national health service body, where the product is supplied or administered in accordance with a Patient Group Direction and the conditions referred to in (b) above are satisfied.

The Order also amends Schedule 1 to the principal Order (which specifies substances which, if included in medicinal products, make them prescription only medicines, and exemptions from the restrictions in section 58(2) on sale and supply of prescription only medicines) and provides for—

(i) an exemption from those restrictions for products containing the substance Ibuprofen where they are for external use, of maximum strength 10 per cent, have a maximum pack size of 100 grams, and are for administration at a maximum dose of 125mg and a maximum daily dose of 500mg;

(ii) the inclusion in Schedule 1 of the substance Terbinafine Hydrochloride, with an exemption for products which are for external use for the treatment of tinea pedis or tinea cruris, with a maximum pack size of 15 grams and a maximum strength of 1 per cent; and

(iii) the inclusion in Schedule 1 of the substances Acamprosate, Aceclofenac, Alendronate Sodium, Anastrozole, Didanosine, Eformoterol Fumarate, Imidapril Hydrochloride, Mirtazapine, Moxonidine, Omeprazole Magnesium, Ranitidine Bismuth Citrate, Rimexolone, Sertraline Hydrochloride, Sevoflurane, Tazarotene and Topiramate.

An assessment of the cost to business of complying with this Order has been made, copies of which have been placed in the libraries of both Houses of Parliament. Further 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.