Statutory Instruments
1998 No. 2170

MEDICINES
The Medicines (Products Other Than Veterinary Drugs) (General Sale List) Amendment Order 1998

Made
2nd September 1998

Coming into force
16th September 1998

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 pursuant to section 129(6) of that Act 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 1998 and shall come into force on 16th September 1998.

(2) In this Order, “the principal Order” means the Medicines (Products Other Than Veterinary Drugs) (General Sale List) Order 1984(3).

(3) In this Order, a reference to a numbered column in a Table, unless otherwise indicated, is a reference to the column bearing that number in Table A, or as the case may be, Table B, of the specified Schedule to the principal 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 the principal Order) is amended in accordance with the following provisions of this article.

(2) In Table A (internal and external use)—

(a)against the entry in column 1 for “Lignocaine”(4)—

(i)there is substituted in column 2 for the entry “(2) 0.6 per cent”, the entry “(2) 2.0 per cent”, and

(ii)there are inserted in column 3, after the words “except local ophthalmic use”, the words “, for use in adults and in children aged 12 years and over”;

(b)there are deleted the entry “Phenolphthalein” in column 1 and the corresponding text “120 mg (MD)” in column 4; and

(c)there are inserted in column 1, at the appropriate point in the alphabetical order of the entries as they appear in that column, each of the entries set out in column 1 of Schedule 1 to this Order, and against the entry “Potassium Chloride” inserted in column 1 by virtue of this sub-paragraph, there is inserted in columns 2 and 3 the corresponding text in columns 2 and 3 of Schedule 1 to this Order.

(3) In Table B (external use only)—

(a)there are inserted in column 1, at the appropriate point in the alphabetical order of the entries as they appear in that column, each of the entries set out in column 1 of Schedule 2 to this Order; and

(b)against the entry “Benzocaine” inserted in column 1 by virtue of this paragraph, there is inserted in columns 2 and 3 the corresponding text in columns 2 and 3 of Schedule 2 to this Order.

Amendment of Schedule 2 to the principal Order

3.  In Table A of Schedule 2 to the principal Order (which specifies the class of medicinal products, the subject of a product licence of right, on general sale by virtue of article 2(b) of the principal Order) there are deleted the entry “Phenolphthalein” in column 1 and the corresponding text “120 mg (MD)” in column 4.

Signed by authority of the Secretary of State for Health

Paul Boateng
Parliamentary Under Secretary of State,
Department of Health
27th August 1998

Jon Owen Jones
Parliamentary Under Secretary of State, The Welsh Office
2nd September 1998

Sam Galbraith
Minister for Health, The Scottish Office
2nd September 1998

Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland on

L.S.
D.C. Gowdy
Permanent Secretary
2nd September 1998.

Article 2(2)(c)

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

Bugleweed

Potassium Chloride
0.15 per cent
Treatment of acute diarrhoea

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

Benzocaine
3.0 per cent
For use in adults and in children aged 12 years and over, except ophthalmic use

Lauromacrogols

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) by amending the entry in Table A (internal and external use) for lignocaine and deleting the entry for phenolphthalein. It also inserts in Table A and Table B (external use only) of Schedule 1 to the principal Order the entries specified in Schedules 1 and 2 to this Order respectively. Phenolphthalein is deleted from Table A of Schedule 2 (medicinal products, the subject of a product licence of right, on general sale), by article 3.
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.


(1)
1968 c. 67; section 1(1)(a) of the 1968 Act, as amended by the Transfer of Functions (Wales) Order 1969 (S.I. 1969/388), contains a definition of “the Health Ministers” and section 1(2) of the 1968 Act contains a definition of “the appropriate Ministers”, both of which are relevant to the powers being exercised in the making of this Order.

(2)
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; 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).

(3)
S.I. 1984/769, amended by S.I. 1985/1540, 1987/910, 1989/969, 1990/1129, 1992/1535, 1994/2410, 1995/3216 and 1997/2043.

(4)
Entry inserted by S.I. 1994/2410.