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This Order further amends the Medicines (Products Other Than Veterinary Drugs) (Prescription Only) Order 1983 (the principal Order) which specifies descriptions and classes of prescription only medicines, that is to say 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.
The amendments made by this Order are as follows:
Article 2 amends the definition of the “Misuse of Drugs Regulations” in the principal Order and makes consequential amendments to the references to those Regulations in articles 6 and 12 of the principal Order.
Article 3 amends articles 3 and 4 of, and Schedule 1 to, the principal Order.
Article 3(1) and (2) makes provision whereby certain topical Hydrocortisone preparations and certain sustained release preparations of Ibuprofen shall not be prescription only medicines notwithstanding that they would otherwise be so by reason that they consist of or contain a substance specified in Part I of Schedule 1 to the principal Order. Such products are specified by name and product licence number in a new Part IV of Schedule 1 to the principal Order which is added by Article 3(5) of this Order.
Article 3(3) amends Part I of Schedule 1 to the principal Order. Article 3(3)(a) adds to the list of prescription only medicines those substances which are set out in Schedule 1 to this Order. Article 3(3)(b) deletes from that list those substances which are set out in Schedule 2 to this Order although such substances remain subject to the provisions of the principal Order by reason either of their being controlled drugs or because they have been relisted in Part I of Schedule 1 to the principal Order under a new approved name. Article 3(3)(c) substitutes a new entry in the list relating to the substance Podophyllum Resin. Article 3(3)(d) makes provision for the circumstances in which a medicinal product containing more than one of the substances Sodium Fluoride, Sodium Monofluorophosphate and Stannous Fluoride combined in a dentifrice shall be a prescription only medicine.
Article 3(4) amends Part III of Schedule 1 to the principal Order (medicinal products, specified by name and product licence number, which are prescription only medicines) by deletion of the entry “Debrisan 0009/0021”.
Article 4 amends Schedule 2 to the principal Order (substances not to be contained in a prescription only medicine sold or supplied under the exemption conferred by article 6(3) of the principal Order, which relates to emergency sale or supply by a retail pharmacist), by deleting certain substances which nonetheless remain excluded from the exemption conferred by article 6(3) by reason of their being controlled drugs.
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