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Statutory Instruments
1995 No. 3216
MEDICINES
The Medicines (Products Other Than Veterinary Drugs) (General Sale List) Amendment Order 1995
Made
11th December 1995
Coming into force
1st January 1996
The Secretaries of State concerned with health in England, in Wales and in Scotland respectively and the Department of Health and Social Services for Northern Ireland, acting jointly in exercise of the powers conferred upon them by sections 51 and 129(4) of the Medicines Act 1968(1) or, as the case may be, those conferred by those provisions and now vested in them(2), and of all other powers enabling them in that behalf, after consulting such organisations as appear to them to be representative of interests likely to be substantially affected by this Order(3) and after consulting and taking into account the advice of the Medicines Commission pursuant to section 129(7) of that Act, hereby make the following Order:
Citation, commencement and interpretation
1.-(1) This Order may be cited as the Medicines (Products Other Than Veterinary Drugs) (General Sale List) Amendment Order 1995 and shall come into force on 1st January 1996.
(2) In this Order, "the principal Order" means the Medicines (Products Other Than Veterinary Drugs) (General Sale List) Order 1984(4).
(3) In this Order, a reference to inserting an entry in a column in a Table of Schedule 1 to the principal Order shall be construed, in the case of an entry to be inserted in column 1, as a reference to inserting that entry at the appropriate point in the alphabetical order of the entries in column 1 of that Table and, in the case of an entry to be inserted (as the case may be) in column 2, 3 or 4 of that Table, as a reference to inserting that entry so as to appear against the column 1 entry against which it is listed in Schedule 1 or, as the case may be, Schedule 2 to this Order.
Amendment of Schedule 1 to the principal Order
2.-(1) Schedule 1 to the principal Order (which specifies the class of medicinal products, other than products the subject of a product licence of right, on general sale by virtue of article 2(a) of that Order) is amended in accordance with the following provisions of this article.
(2) In Table A (internal or external use)-
(a)there are inserted in column 1 and, as the case may be, columns 2, 3 and 4, the entries set out in columns 1, 2, 3 and 4 respectively of Schedule 1 to this Order;
(b)in relation to the substance "Benzoin Tincture, Compound BP"-
(i)there is inserted in column 2 the entry
"(2) 0.8 per cent.", and
(ii)there are substituted, for the entries in column 3, the entries
"(1) Internal: vapour inhalations
(2) Internal: pastilles
(3) External";
(c)in relation to the substance "Folic Acid", there is substituted for the entry in column 4 the entry "500 mcg (MDD)".
(3) In Table B (external use only), there are inserted in column 1 and, as the case may be, columns 2 and 3, the entries set out in columns 1, 2 and 3 respectively of Schedule 2 to this Order.
Signed by authority of the Secretary of State for Health
Gerald Malone
Minister of State
Department of Health
4th December 1995
William Hague
Secretary of State for Wales
11th December 1995
James Douglas Hamilton
Minister of State The Scottish Office
11th December 1995
Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland on
L.S.
F. A. Elliott
Permanent Secretary
7th December 1995.
Article 2(2)(a)
SCHEDULE 1ENTRIES INSERTED IN TABLE A OF SCHEDULE 1 TO THE PRINCIPAL ORDER (INTERNAL OR EXTERNAL USE)
| Column 1 | Column 2 | Column 3 | Column 4 |
|---|---|---|---|
| Substance | Maximum strength | Use, pharmaceutical form or route of administration | Maximum dose and maximum daily dose |
| Choline Bitartrate | |||
| Equisetum | |||
| Ibuprofen | (1) 200 mg | (1) Internal: tablets, capsules, powder or granules, in each case for use in adults and in children over the age of 12 years only and for treatment of the following only-“ rheumatic or muscular pain backache neuralgia migraine headache dental pain dysmenorrhoea feverishness symptoms of colds and influenza | (1) 400 mg (MD) 1200 mg (MDD) |
(2) 5.0 per cent. | (2) External: for use in adults and in children over the age of 12 years only and for treatment of the following only-“ rheumatic pain muscular aches pains or swellings such as strains, sprains and sports injuries | (2) 125 mg (MD) 500 mg (MDD) | |
| Magnesium Alginate |
Article 2(3)
SCHEDULE 2ENTRIES INSERTED IN TABLE B OF SCHEDULE 1 TO THE PRINCIPAL ORDER (EXTERNAL USE ONLY)
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| Substance | Maximum strength | Use, pharmaceutical form or route of administration |
| Capsicum Oleoresin | ||
| Capsicum Oleoresin (Water soluble) | ||
| Clotrimazole | 1.0 per cent. | For treatment of tinea pedis (athlete's foot) only |
Explanatory Note
(This note is not part of the Order)
This Order further amends the Medicines (Products Other Than Veterinary Drugs) (General Sale List) Order 1984 ("the principal Order") which specifies classes of medicinal products which can with reasonable safety be sold or supplied otherwise than by or under the supervision of a pharmacist (the general sale list).
Article 2 amends Schedule 1 to the principal Order (medicinal products, other than products the subject of a product licence of right, on general sale). Article 2(2) inserts in Table A (internal or external use) of that Schedule the entries specified in Schedule 1 to this Order and amends other entries in Table A as described in paragraph (2)(a) to (c).
Article 2(3) inserts in Table B (external use only) of Schedule 1 to the principal Order the entries specified in Schedule 2 to this Order.
1968 c. 67. The expressions "the appropriate Ministers" and "the Health Ministers" are defined in section 1 of that Act as amended by S.I. 1969/388, Schedule 1.
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. 1969/388">1969/388); in the case of the Department of Health and Social Services for Northern Ireland 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).
See section 129(6) of the Medicines Act 1968.