Explanatory note

This Order 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 in accordance 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 the principal Order products are included in a class of such 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—

• amendments to the conditions under which Domperidone Maleate, Minoxidil and Nizatidine may be sold or supplied otherwise than as prescription only medicines;

• the inclusion in Schedule 1 to the principal Order of products containing the substances Phenolphthalein, Pirenzepine Dihydrochloride Monohydrate and Quinapril Hydrochloride; and

• the addition of Bretylium Tosylate to the list of substances in Part III of Schedule 5 to the principal Order which may be administered by ambulance paramedics.

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.