Citation, interpretation and commencement

1. This Order, which may be cited as the Medicines (Products Other Than Veterinary Drugs) (Prescription Only) Amendment Order 1987, amends the Medicines (Products Other Than Veterinary Drugs) (Prescription Only) Order 1983(3) (hereinafter referred to as "the principal Order") and shall come into force on 30th April 1987.

Amendment of articles 1, 6 and 12 of the principal Order

2.-(1) In article 1(2) of the principal Order (interpretation) for the definition of "the Misuse of Drugs Regulations" there is substituted the following definition:

• ""the Misuse of Drugs Regulations" means, in relation to England, Wales and Scotland, the Misuse of Drugs Regulations 1985(4) and, in relation to Northern Ireland, the Misuse of Drugs (Northern Ireland) Regulations 1986(5);".

(2) In article 6(2)(d), (4)(c) and (5) of the principal Order (which refers to emergency sale or supply by a retail pharmacist) and in article 12(2)(b) of the principal Order (conditions relating to prescriptions), for the words, "Schedule 2, 3 or 4 to the Misuse of Drugs Regulations" there are substituted the words, "Schedule 1, 2 or 3 to the Misuse of Drugs Regulations".

Amendment of articles 3 and 4 of, and Schedule 1 to, the principal Order

3.-(1) In article 3(1)(a) of the principal Order (medicinal products on prescription only), after the words "subject to article 4(1)" there are inserted the words "and (1A), and Part IV of Schedule 1".

(2) In article 4 of the principal Order (medicinal products that are not prescription only), after paragraph (1) there is inserted the following paragraph-

"(1A) Notwithstanding article 3(1)(a), medicinal products specified in Part IV of Schedule 1 shall not be prescription only medicines."

(3) In Part I of Schedule 1 to the principal Order (which lists substances which render a medicinal product a prescription only medicine except in circumstances also listed)-

(a)there are inserted in column 1, at the appropriate point in the alphabetical order of the substances listed, the substances specified in column 1 of Schedule 1 to this Order and in columns 2 and 3, so as to appear against the particular substance to which it relates, there is inserted as the case may be any entry appearing in columns 2 and 3 of Schedule 1 to this Order against that substance;

(b)there are deleted from column 1 the substances specified in Schedule 2 to this Order;

(c)for the entry in columns 2 and 3 relating to the substance Podophyllum Resin listed in column 1 there is substituted the entry relating to that substance set out in columns 2 and 3 of Schedule 3 to this Order;

(d)(i)in the footnote to the column 4 entries relating to the substances Atropine, Atropine Methobromide, Atropine Methonitrate, Atropine Oxide Hydrochloride, Atropine Sulphate, Hyoscine Butylbromide, Hyoscine Hydrobromide, Hyoscine Methobromide, Hyoscine Methonitrate, Hyoscyamine, Hyoscyamine Hydrobromide and Hyoscyamine Sulphate, after the words, "Subject to" there are inserted the words, "paragraph 1 of"; and

(ii)in column 2 opposite each of the substances Sodium Fluoride, Sodium Monofluorophosphate and Stannous Fluoride there is inserted "(b)" and at the foot of each page where such an insertion is made there are inserted the words, "(b) Subject to paragraph 2 of the note at the end of Part I of Schedule 1."; and

(iii)after the word "Note:" where it appears at the end of that Part there is inserted the number "1." and after the entry for the Note numbered 1. there is inserted the following new paragraph:

"2. In relation to a medicinal product which contains more than one of the substances Sodium Fluoride, Sodium Monofluorophosphate and Stannous Fluoride combined in a dentifrice, the maximum strength of the combination for the purposes of column 2 shall not exceed 0.15 per cent calculated as Fluorine."

(4) In Part III of Schedule 1 to the principal Order (medicinal products, specified by name and product licence number, which are prescription only medicines) there is deleted the entry "Debrisan 0009/0021".

(5) After Part III of Schedule 1 to the principal Order there is added Part IV as set out in Schedule 4 to this Order.

Amendment of Schedule 2 to the principal Order

4. From 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), there are deleted the substances Phentermine Hydrochloride and Phentermine Resin Complex.

Article 3(3)(a)

SCHEDULE 1ENTRIES INSERTED IN PART I OF SCHEDULE 1 TO THE PRINCIPAL ORDER(6)

Article 3(3)(b)

SCHEDULE 2SUBSTANCES DELETED FROM PART I OF SCHEDULE 1 TO THE PRINCIPAL ORDER

Alprazolam

Bromazepam

Chlordiazepoxide

Clobazam

Clonazepam

Dextropropoxyphene Hydrochloride

Dextropropoxyphene Napsylate

Diazepam

Ethchlorvynol

Flunitrazepam

Flurazepam Hydrochloride

Flurazepam Monohydrochloride

Glutethimide

Ketazolam

Loprazolam Mesylate

Lorazepam

Lormetazepam

Mazindol

Medazepam

Meprobamate

Methyprylone

Mithramycin

Nitrazepam

Oxazepam

Pentazocine Hydrochloride

Pentazocine Lactate

Phentermine Hydrochloride

Phentermine Resin Complex

Prazepam

Sutoprofen

Temazepam

Triazolam

Article 3(3)(c)

SCHEDULE 3ENTRY SUBSTITUTED IN COLUMNS 2 AND 3 OF PART I OF SCHEDULE 1 TO THE PRINCIPAL ORDER(7)

Article 3(5)

SCHEDULE 4ADDITION OF PART IV OF SCHEDULE 1 TO THE PRINCIPAL ORDER

"PART IVname and product licence number of medicinal products that are not prescription only medicines

Anflam Cream 0142/0190

Anflam Ointment 0142/0191

Beechams Hydrocortisone Cream 0079/0203

Cortaid Cream 1% 0032/0126

Cortaid Ointment 1% 0032/0127

Corteze Cream 0001/0107

Cortiderm 2855/0010

Cortovate Hydrocortisone Cream 1% 0039/0198

Cortril Topical Ointment 1% (non-greasy) 0057/0251

CP Hydrocortisone Cream 0.5% 4543/0238

CP Hydrocortisone Cream 1% 4543/0239

CP Hydrocortisone Ointment 0.5% 4543/0236

CP Hydrocortisone Ointment 1% 4543/0237

Dermacort Hydrocortisone Cream 0129/0076

Efcortelan P Cream 1% 0004/0327

Efcortelan P Ointment 1% 0004/0326

Femafen 0188/0071

Hc45 Hydrocortisone Cream 0327/0039

Kerfoot Hydrocortisone Cream 1% 0058/0092

Lanacort Cream 3157/0008

Lanacort Ointment 3157/0011

Medicort Cream 3920/0010

Oriel Capsules 0073/0023

Pharmacort Cream 0.5% 0011/0077

Proflex Sustained Relief Capsules 0001/0109

Suspren 0188/0072

Timocort Hydrocortisone Cream 0044/0090

Wasp-Eze Hydrocortisone Cream 0232/0058

Wasp-Eze Hydrocortisone Ointment 0232/0059

Zenoxone Cream 0181/0033

Zenoxone Ointment 0181/0032"

Explanatory Note

(This note is not part of the Order)

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.