The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 1999

Explanatory Note

(This note is not part of the Order)

This Order further amends the Prescription Only Medicines (Human Use) Order 1997 (“the principal Order”) which specifies descriptions and classes of prescription only medicines (i.e. medicinal products which, subject to exemptions, may be sold or supplied by retail, only with a prescription given by an appropriate practitioner, and which may be administered only by or in accordance with the directions of such a practitioner). Under Schedule 1 to the principal Order, products are included in a class of medicines by reason of the substances contained in them, subject to their being excluded in specified circumstances.

The amendments made by this Order are as follows–

Amendment of the conditions under which products containing the substance Felbinac may be sold or supplied otherwise than as a prescription only medicine (to increase from 30g to 50g the maximum amount of medicinal product that may be contained in a container or package);

The inclusion in Schedule 1 to the principal Order of the substance Levocarnitine with an exemption where products are for use for dietary supplementation;

The inclusion in Schedule 1 to the principal Order of the substances Adapalene, Altretamine, Apraclonidine Hydrochloride, Bicalutamide, Calcipotriol Hydrate, Citalopram Hydrobromide, Dorzolamide Hydrochloride, Exemestane, Ferumoxsil, Moexipril Hydrochloride, Quinagolide Hydrochloride, Sparfloxacin, Tizanidine Hydrochloride, Valaciclovir Hydrochloride, Venlafaxine Hydrochloride and Zalcitabine.

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 1207 Market Towers, 1 Nine Elms Lane, London SW8 5NQ.