The Medicines (Products Other Than Veterinary Drugs) (General Sale List) Amendment (No. 2) Order 2000

Statutory Instruments

2000 No. 2526

MEDICINES

The Medicines (Products Other Than Veterinary Drugs) (General Sale List) Amendment (No. 2) Order 2000

Made

12th September 2000

Coming into force

4th October 2000

As respects England, Scotland and Wales, the Secretary of State concerned with health in England, and, as respects Northern Ireland, the Minister of Health, Social Services and Public Safety, acting jointly, in exercise of the powers conferred on them by sections 51 and 129(4) of the Medicines Act 1968(1) or, as the case may be, the powers 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 taking into account the advice of the Committee on Safety of Medicines and 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 (No. 2) Order 2000 and shall come into force on 4th October 2000.

(2) In this Order—

(a) “the principal Order” means the Medicines (Products Other Than Veterinary Drugs) (General Sale List) Order 1984(3);

(b) “Table A of Schedule 1” means Table A (internal or external use) of 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);

(c) “Table B of Schedule 1” means Table B (external use only) of Schedule 1 to the principal Order.

Amendment of Table A of Schedule 1 to the principal Order

2.  In Table A of Schedule 1, there is inserted in column 1, at the appropriate place in the alphabetical order of the entries as they appear in that column, the entry set out in column 1 of the Table below, and against that entry there is inserted in columns 2, 3 and 4 the corresponding text in columns 2, 3 and 4 of the Table below—

Column 1	Column 2	Column 3	Column 4
Substance	Maximum strength	Use, pharmaceutical form or route of administration	Maximum dose and maximum daily dose
Famotidine	10mg	Tablets: for the short-term symptomatic relief of heartburn, indigestion, acid indigestion and hyperacidity	10mg (MD) 20mg (MDD).

Amendment of Table B of Schedule 1 to the principal Order

3.  In Table B of Schedule 1, there is inserted in column 1, at the appropriate place in the alphabetical order of the entries as they appear in that column, the entries set out in column 1 of the Table below, and against the entry for Heparinoid there are inserted in columns 2 and 3 the corresponding text in columns 2 and 3 of the Table below—

Column 1	Column 2	Column 3
Substance	Maximum strength	Use, pharmaceutical form or route of administration
Alpha-pinene
Heparinoid	1.0 per cent	For the relief of bruises, sprains and soft tissue injuries in adults and in children aged 6 years and over.

Signed by authority of the Secretary of State for Health

Yvette Cooper

Parliamentary Under Secretary of State for Public Health,

Department of Health

12th September 2000

Bairbre de Brún

Minister of Health, Social Services and Public Safety

11th September 2000

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 Table A (internal and external use) of Schedule 1 to the principal Order (medicinal products, other than products the subject of a product licence of right, on general sale) by inserting an entry for Famotidine for tablets of maximum strength 10mg, for use for the short-term symptomatic relief of heartburn, indigestion, acid indigestion and hyperacidity, with a maximum dose of 10mg and a maximum daily dose of 20mg.

Article 3 amends Table B (external use only) of Schedule 1 to the principal Order by inserting an entry for Alpha-pinene, and an entry for Heparinoid for products of maximum strength 1.0 per cent for the relief of bruises, sprains and soft tissue injuries in adults and in children aged 6 years and over.

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 10–202, Market Towers, 1 Nine Elms Lane, London SW8 5NQ.

(1)

1968 c. 67; the expression “the appropriate Ministers”, and the expression “the Health Ministers” which is relevant to the powers being exercised in the making of this Order, are defined in section 1 of that Act as amended by article 2(2) of, and Schedule 1 to, S.I. 1969/388, and by articles 2(1) and 5 of, and the Schedule to, S.I. 1999/3142.

(2)

In the case of the Secretary of State concerned with health in England, by virtue of article 2(2) of, and Schedule 1 to, S.I. 1969/388, and articles 2(1) and 5 of, and the Schedule to, S.I. 1999/3142; and in the case of the Minister of Health, Social Services and Public Safety, by virtue of section 95(5) of, and paragraph 10 of Schedule 12 to, the Northern Ireland Act 1998 (c. 47).

(3)

S.I. 1984/769, amended by S.I. 1985/1540, 1987/910, 1989/969, 1990/1129, 1992/1535, 1994/2410, 1995/3216, 1997/2043, 1998/2170, 1999/852 and 2535, and 2000/1092.