The Medicines (Products Other Than Veterinary Drugs) (General Sale List) Amendment Order 1994

Made: 7th September 1994

Coming into force: 12th October 1994

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 powers conferred upon them by sections 51 and 129(4) of the Medicines Act 1968[^f00001] or, as the case may be, those conferred by those provisions and now vested in them[^f00002], 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[^f00003] 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 1994 and shall come into force on 12th October 1994.

• (2) In this Order, “the principal Order” means the Medicines (Products Other Than Veterinary Drugs) (General Sale List) Order 1984[^f00004].

• (3) In this Order, a reference to inserting an entry in a column in a Table of a Schedule 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 (except where the context otherwise requires), 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 article 1(2) of the principal Order

2

In article 1(2) of the principal Order (interpretation), after the definition of “dosage unit” there is inserted the following definition—

• “effervescent”, in relation to a tablet, means containing not less than 75 per cent., by weight of the tablet, of ingredients included wholly or mainly for the purpose of releasing carbon dioxide when the tablet is dissolved or dispersed in water;

Amendment of Schedule 1 to the principal Order

3

• (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, those entries set out in columns 1, 2, 3 and 4 respectively of Schedule 1 to this Order;

• (b) in relation to the substance “Aspirin”—

• (i) there is inserted in column 2 the entry “(3) 500 mg”,

• (ii) there is substituted, for the entry “(1) Tablet or capsule” in column 3, the entry “(1) Tablet (except effervescent tablet) or capsule” and

• (iii) there is inserted in column 3 the entry “(3) Effervescent tablets”;

• (c) there are omitted the entry “Capsicum Oleoresin” in column 1 and the entries in relation to it in columns 2, 3 and 4;

• (d) in relation to the substance “Chlorbutol”—

• (i) there is inserted in column 2 the entry “(4) 7.0 per cent.”,

• (ii) there is substituted, for the entry “(3) External” in column 3, the entry “(3) External (except toothache gel)”, and

• (iii) there is inserted in column 3 the entry “(4) External: toothache gel”;

• (e) for the entry “Cranesbill Root” in column 1, there is substituted the entry “Cranesbill (Geranium)”;

• (f) for the entry “Dandelion Root” in column 1, there is substituted the entry “Dandelion”;

• (g) in relation to the substance “Ferrous Sulphate”, there is inserted in column 2 the entry

(2) 15.8 per cent. (Fe SO4 7H2O)

, and in column 3 the entries

(1) Internal: except for use as cyanide antidote (2) Internal: for use as cyanide antidote only

and for the entry in column 4 there is substituted the entry

(1) Equivalent to 24 mg elemental Iron (MD)

• (h) in relation to the substance “Nicotinamide”, there is inserted in column 4 the entry “300 mg (MDD)”;

• (i) in relation to the substance “Nicotinic Acid”, there is inserted in column 4 the entry “100 mg (MDD)”;

• (j) in relation to the substance “Salicylic Acid”, there is inserted in column 2 at the end the entry “(h) 3.0 per cent.” and there are inserted in column 3 at the end the entries “(h) soap” and “(i) wart plasters”;

• (k) in relation to the substance “Zinc Oxide”, for the entry in column 4 there is substituted the entry “Equivalent to 5 mg elemental Zinc (MDD)”; and

• (l) in relation to the substance “Zinc Sulphate”, for the entry in column 4 there is substituted the entry “(1) Equivalent to 5 mg elemental Zinc (MDD)”.

• (3) In Table B (external use only)—

• (a) there are inserted in column 1 and, as the case may be, columns 2 and 3, those entries set out in columns 1, 2 and 3 respectively of Schedule 2 to this Order;

• (b) there are omitted the entries “Hamamelis” and “Siberian Fir Oil” in column 1;

• (c) there are omitted the entry “Lignocaine” in column 1 and the entry “0.6 per cent” in relation to it in column 2;

• (d) there are omitted the entry “Lignocaine Hydrochloride” in column 1 and the entry “0.7 per cent” in relation to it in column 2;

• (e) in relation to the substance “Povidone-Iodine”, for the entry in column 3 there is substituted the entry “All preparations except those for use in surgical operations and those for vaginal use”.

SCHEDULE 1 — ENTRIES INSERTED IN TABLE A OF SCHEDULE 1 TO THE PRINCIPAL ORDER (INTERNAL OR EXTERNAL USE)

SCHEDULE 2 — ENTRIES INSERTED IN TABLE B OF SCHEDULE 1 TO THE PRINCIPAL ORDER (EXTERNAL USE ONLY)

Signed

Signed by authority of the Secretary of State for Health

Tom Sackville — Parliamentary Under Secretary of State, — Department of Health — 16th September 1994

John Redwood — Secretary of State for Wales — 6th September 1994

Allan Stewart — Parliamentary Under Secretary of State, The Scottish Office — 6th September 1994

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

F. A. Elliott — Permanent Secretary — 7th September 1994.

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 inserts a definition of “effervescent” in the principal Order.

Article 3 amends Schedule 1 to the principal Order (medicinal products, other than products the subject of a product licence of right, on general sale). Article 3(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)(d) to (l).

Article 3 (3) inserts in Table B (external use only) of Schedule 1 to the principal Order the entries specified in Schedule 2 to this Order, omits from Table B the entries in respect of Hamamelis, Siberian Fir Oil, Lignocaine and Lignocaine Hydrochloride (which now appear, amended, in Table A of that Schedule) and amends the entry in respect of Povidone-Iodine.

Footnotes

[^f00001]: 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.

[^f00002]: 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).

[^f00003]: See section 129(6) of the Medicines Act 1968.

[^f00004]: S.I. 1984/769, amended by S.I. 1985/1540, 1987/910, 1989/969, 1990/1129 and 1992/1535.