Medicines (Prescription Only, Pharmacy and General Sale) Amendment Order 1989

JurisdictionUK Non-devolved

1989No. 1852

MEDICINES

The Medicines (Prescription Only, Pharmacy and General Sale)

Amendment Order 1989

9thOctober1989

11thOctober1989

1stNovember1989

The Secretary of State concerned with health in England, the Secretaries of State concerned with health and with agriculture in Wales and in Scotland, the Minister of Agriculture, Fisheries and Food, the Department of Health and Social Services for Northern Ireland and the Department of Agriculture for Northern Ireland, acting jointly, in exercise of powers conferred by sections 1, 57(1) and (2), 58(1), (4)(a) and (5), 129(4) and 132(1) of the Medicines Act 1968 ( a) and now vested in them ( b), and of all other powers enabling them in that behalf, after consulting in accordance with section 129(6) of that Act such organisations as appear to them to be representative of interests likely to be substantially affected by this Order, after consulting the Medicines Commission in accordance with section 58(6) of that Act so far as this Order is made under section 58 of that Act and after taking into account the advice of the Medicines Commission in accordance with section 129(7) of that Act, hereby make the following Order:-

Citation, commencement and interpretation

1.-(1) This Order, which may be cited as the Medicines (Prescription Only, Pharmacy and General Sale) Amendment Order 1989, shall come into force on 1st November 1989.

(2) In this Order-

"the Pharmacy and General Sale Exemption Order" means the Medicines (Pharmacy and General Sale-Exemption) Order 1980 ( c);

"the Prescription Only Medicines Order" means the Medicines (Products Other Than Veterinary Drugs) (Prescription Only) Order 1983 ( d);

Amendment of article 1 of the Prescription Only Medicines Order

2. In article 1(2)(a) of the Prescription Only Medicines Order (interpretation), the following definition is inserted after the definition of "occupational health scheme":-

(a) 1968 c.67; see the meaning assigned to "the appropriate Ministers" by sections 1 and 132(1).

(b) In the case of the Secretaries of State concerned with health in England and in Wales by virtue of article 2(2) of, and Schedule 1 to, the Transfer of Functions (Wales) Order 1969 (S.I. 1969/388); in the case of the Secretary of State concerned with agriculture in Wales by virtue of article 2(3) of, and Schedule 1 to, the Transfer of Functions (Wales) (No. 1) Order 1978 (S.I. 1978/272); in the case of the Northern Ireland Departments by virtue of section 40 of, and Schedule 5 to, the Northern Ireland Constitution Act 1973 (c.36), and section 1(3) of, and paragraph 2(1)(b) of Schedule 1 to, the Northern Ireland Act 1974 (c.28).

(c) S.I. 1980/1924, as amended by S.I. 1982/27.

(d) S.I. 1983/1212, as amended by S.I. 1984/756, 1986/586, 1987/674, 1250 and 1988/2017.

""offshore installation" means an offshore installation within the meaning of the Mineral Workings (Offshore Installations) Act 1971 ( a) which is within-

(a) tidal waters and parts of the sea in or adjacent to Great Britain up to the seaward limit of territorial waters;(b) waters in any area designated under section 1(7) of the Continental Shelf Act 1964 ( b);".

Amendment of article 4 of the Prescription Only Medicines Order

3. In article 4 of the Prescription Only Medicines Order (medicinal products that are not prescription only), the following paragraph is inserted after paragraph (1B):-

"(1C) Notwithstanding Article 3(1)(a), a medicinal product shall not be a prescription only medicine by reason of the fact that it consists of or contains the substance mebendazole where it is sold or supplied in a container or package containing only a single dose of not more than 100 mg of mebendazole for oral use and for the treatment of enterobiasis.".

Amendment of Part 1 of Schedule 1 to the Prescription Only Medicines Order

4. In Part I of Schedule 1 to the Prescription Only Medicines Order (which lists substances which render a medicinal product a prescription only medicine except in circumstances also listed)-

(a) the following substances are inserted at the appropriate points in the alphabetical order of the substances listed in Column 1-

Acipimox

Aztreonam

Bentiromide

Bisoprolol Fumarate

Buserelin Acetate

Carboplatin

Carteolol Hydrochloride

Ceftriaxone Sodium

Ceruletide Diethylamine

Doxazosin Mesylate

Enoximone

Famotidine

Felodipine

Fenofibrate

Flumazenil

Fluorescein Dilaurate

Fluoxetine Hydrochloride

Ganciclovir

Gestodene

Goserelin Acetate

Lisinopril

Lofexidine Hydrochloride

Lysuride Maleate

Meglumine Gadopentetate

Meglumine Iothalamate

Metipranolol

Misoprostol

Naltrexone Hydrochloride

Nimodipine

Nizatidine

Oxidronate Sodium

Somatropin

Sulbenicillin

Sultamicillin Tosylate

(a) 1971 c.61; section 1 was substituted by section 24 of the Oil and Gas (Enterprise) Act 1982 (c.23).

(b) 1964 c.29.

Tenoxicam

Terazosin Hydrochloride

Xamoterol Fumarate;

(b) for the entries relating to the substances Dextromethorphan Hydrobromide and Ibuprofen respectively there are substituted the entries relating respectively to those substances set out in Schedule 1 to this Order.

Amendment of Table A of Part IV of Schedule 1 to the Prescription Only Medicines Order

5. In Table A of Part IV of Schedule 1 to the Prescription Only Medicines Order (medicinal products specified by name and product licence number which are not prescription only medicines), the following entries are deleted:-

Femafen

0188/0071;

Oriel Capsules

0073/0023;

Proflex Sustained Relief Capsules

0001/0109; and

Suspren

0188/0072.

Amendment of Schedule 3 to the Prescription Only Medicines Order

6. In Schedule 3 to the Prescription Only Medicines Order (exemptions for certain persons from the provisions of section 58(2) of the Medicines Act 1968)-

(a) in paragraph 5 in Column 2 of Part I, the following sub-paragraphs are substituted for sub-paragraph (a)-"(a)...

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