Statutory Instrument 1997 No. 2043

      The Medicines (Products Other Than Veterinary Drugs) (General Sale List) Amendment Order 1997


      © Crown Copyright 1997

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STATUTORY INSTRUMENTS


1997 No. 2043

MEDICINES

The Medicines (Products Other Than Veterinary Drugs) (General Sale List) Amendment Order 1997

  Made 21st August 1997 
  Coming into force 16th September 1997 

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] ("the Act") 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 the Act and after consulting and taking into account the advice of the Medicines Commission pursuant to section 129(7) of the 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 1997 and shall come into force on 16th September 1997.

    (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, references to "Table A" or "Table B" are references to Table A or Table B respectively of Schedule 1 to the principal Order and 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.

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 "Camphor", there shall be substituted in column 4 for the entry "10mg (MD)", the entry "20mg (MD)";

    (b) in column 1 there are added - 

      (i) in the entry for "Methionine, DL", after the words "Methionine, DL", the words "except when combined with Paracetamol", and

      (ii) in the entry for "Paracetamol", after the word "Paracetamol", the words "except when combined with Methionine, DL";

    (c) against the entry in column 1 for "Paracetamol" there are added - 

      (i) in column 2 the entries "(3) 2.5 per cent (adults and persons aged 12 years and above)" and "(4) 2.4 per cent (persons under 12 years)",

      (ii) in column 3 the entries "(3) liquid preparations" and "(4) liquid preparations", and

      (iii) in column 4 the entry "(4) 480 mg (MD) 1920 mg (MDD)"; and

    (d) there are inserted in column 1 and, as the case may be, columns 2, 3 and 4, at the appropriate point in the alphabetical order of the entries as they appear in column 1, each of the entries set out in column 1 of Schedule 1 to this Order, together with the corresponding text in columns 2, 3 and 4 respectively of that Schedule.

    (3) In Table B (external use only), there are inserted in column 1 and, as the case may be, columns 2 and 3, at the appropriate point in the alphabetical order of the entries as they appear in column 1, each of the entries set out in column 1 of Schedule 2 to this Order, together with the corresponding text in columns 2 and 3 respectively of that Schedule.


Frank Dobson,
Secretary of State for Health

12th August 1997


Win Griffiths,
Parliamentary Under-Secretary of State,Welsh Office

20th August 1997


Sam Galbraith,
Parliamentary Under-Secretary of State,The Scottish Office

21st August 1997



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

L.S.


D. C. Gowdy,
Permanent Secretary

21st August 1997.



SCHEDULE 1
Article 2(2)(d)


ENTRIES 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
Cypripedium

Dequalinium Chloride

  Minor infections of the mouth and throat 0.25mg (MD)

2mg (MDD)

Loperamide Hydrochloride 2mg Symptomatic treatment of acute diarrhoea, in adults and children aged 12 years and over 4mg (MD)

12mg (MDD)

Menthyl Valerate Quinine Base 100mg   200mg (MD)

35mg (MD)

Sodium Picosulphate Water 0.1 per cent Adults and children aged 10 years and over 15mg (MD)

15mg (MDD)




SCHEDULE 2
Article 2(3)


ENTRIES INSERTED IN TABLE B OF SCHEDULE 1 TO THEPRINCIPAL ORDER(EXTERNAL USE ONLY)


Column 1 Column 2 Column 3
Substance Maximum strength Use, pharmaceutical form or route of administration
Benzoyl Peroxide 2.5 per cent For the treatment of spots or pimples on the face
Miconazole Nitrate 2.0 per cent (for spray powders this shall be weight for weight excluding any propellants) Creams or powders, including spray powders For the 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) by amending the entries in Table A (internal and external use) for methionine and paracetamol so that those two substances combined shall not be on the general sale list, by amending the entry for camphor and by including in Table A liquid preparations of paracetamol, with different provisions for maximum strength and maximum dosage for adults and children aged under 12. 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.


Notes:

[1] 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.back

[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 (S.I. 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).back

[3] S.I. 1984/769, amended by S.I. 1985/1540, 1987/910, 1989/969, 1990/1129, 1992/1535, 1994/2410 and 1995/3216.back



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© Crown copyright 1997
Prepared 14 October 1997