The Medicines (Products Other Than Veterinary Drugs) (General Sale List) Amendment Order 1994 No. 2410


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United Kingdom Statutory Instruments


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Statutory Instruments

1994 No. 2410

MEDICINES

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(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 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(4).

(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-

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".

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

L.S.

F. A. Elliott

Permanent Secretary

7th September 1994.

Article 3(2)(a)

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

Column 1Column 2Column 3Column 4
SubstanceMaximum strengthUse, pharmaceutical form or route of administrationMaximum dose and maximum daily dose
Acerola
Agnus castus (Chaste Tree)
Air
Alexitol Sodium
Alpha Tocopheryl Acid Succinate
Aluminium Carbonate (Basic)
Aluminium Oxide
Aminoacetic Acid (Glycine)
Aminobenzoic Acid

(1) Internal

(2) External

(1) 30mg (MDD)
Ammonium Acetate Solution Strong
Amyloglycosidase Concentrate
Anethole
Aniseed (Anise)
Arrowroot
Balm of Gilead
Bayberry
Betacarotene6 mg (MDD)
Bismuth Aluminate6 mg (MD), calculated as Bismuth Oxide
Black Catechu
Black Haw
Blackberry
Black Currant
Bladderwrack (Fucus)
Blue Cohosh (Caulophyllum)265 mg (MD)
Boneset (Eupatorium perfoliatum)
Buckthorn
Butternut (White Walnut)
Calamus (Sweet Flag)
Calcium Chloride
Calcium Heptagluconate
Calcium Phosphate
Calumba
Capsicum Oleoresin BPC 1923
Capsicum Oleoresin BPC 1973(1) Internal(1) 1.2mg (MD)
(1) 1.8mg (MDD)
(2) 2.5 per cent.(2) External
Caraway Oil
Centaury
Chickweed
Chlorophenols

(1) 1 mg

(2) 0.6 per cent.

(1) Internal

(2) External

Cinnamic Acid(1) 500 mcg

(1) Internal: pastilles, lozenges, throat tablets

(2) External

Clove
Clover (Red Clover)
Cobalt SulphateEquivalent to 0.25 mg elemental Cobalt (MDD)
Coriander
Dexpanthenol (Panthenol, Pantothenol)
Docosahexaenoic Acid (DHA)
Domiphen Bromide
Eicosapentaenoic Acid (EPA)
Euphorbia hirta (Euphorbia pilulifera, Pill-Bearing Spurge)
Fast Green FCF
Fennel Oil
Fenugreek
Ferric ChlorideEquivalent to 24 mg elemental iron (MD)
Fibre, Vegetable
Fig
Fir Oil, Siberian
Frangulin
Fringe Tree
Fumitory160 mg (MD)
Ginseng
Glutamic Acid Hydrochloride
Glycerophosphoric Acid
Gravel Root (Eupatorium purpureum)
Hamamelis
Heartsease
Hemlock Spruce (Pine Canadian)400 mg (MD)
Horseradish
Hydrangea
Iceland Moss
Inositol
Iodophenol

(1) 0.2 mg

(2) 0.08 per cent.

(1) Internal: pastilles, lozenges, throat tablets

(2) External

Kaolin Heavy
Kava625 mg (MD)
Kelp
Lady's Mantle
Lemon
Lignocaine

(1) 0.6 per cent.

(2) 0.6 per cent.

(1) Internal: teething gel

(2) External, except local ophthalmic use

Lignocaine Hydrochloride

(1) 0.7 per cent.

(2) 0.7 per cent.

(1) Internal: teething gel

(2) External, except local ophthalmic use

Liquorice Extract Deglycyrrhizinised
Lucerne (Alfalfa)
Lungwort
Magnesium Stearate
Maize
Malted Milk
Maltose
Manganese GlycerophosphateEquivalent to 1 mg elemental Manganese (MDD)
Marshmallow Root
Methionine, DL
Motherwort
Myrrh
Nutmeg
Oak Bark
Orange
Pantothenic Acid
Papain
Parsley
Pellitory
Pilewort
Pleurisy Root
Poke Root (Phytolacca)

(1) Internal

(2) External

(1) 120 mg (MD)
Poplar (Aspen)
Potassium Acid Tartrate
Potassium Bicarbonate
Potassium Carbonate
Potassium Citrate
Potassium MolybdateEquivalent to 200 mcg elemental molybdenum (MDD)
Psyllium
Queen's Delight320 mg (MD)
Raspberry
Rosemary
Rubellin
Rutin
Saw Palmetto
Shepherd's Purse
Skunk Cabbage (Symplocarpus)
Sodium Sulphate
Sodium Acid Phosphate
Sodium Glycerophosphate
Sodium Phosphate
Squaw Vine
Squill, Indian
Stone Root
Tilia (Lime Flowers)
Unicorn Root False
Uva Ursi (Bearberry)
Wahoo (Euonymus atropurpureus)
Watercress
Wheat
Wild Indigo
Wood Betony
Xanthan Gum
Yellow Dock
Zinc GluconateEquivalent to 5 mg elemental zinc (MDD)

Article 3(3)(a)

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

Column 1Column 2Column 3
SubstanceMaximum StrengthUse, Pharmaceutical Form or Route of Administration
Aldioxa (Aluminium Dihydroxyallantoinate)
Allantoin
Aminacrine Hydrochloride
Arnica
Bay Oil
Borax (Sodium Borate)

(1) 5.0 per cent.

(2) 0.7 per cent.

(1) All preparations except ophthalmic lotions

(2) Ophthalmic lotions

Boric Acid2.5 per cent.
Bryony, Black
Burgundy Pitch
Calcium Undecylenate
Calendula (Marigold)
Cedar Wood Oil
Colophony
Comfrey Root
Crotamiton
Dichlorotetrafluroethane
Emulsifying Wax
European Birch
Geranium Oil
Guaiacol
Halquinol0.6 per cent.
Heparin
Hexetidine0.1 per cent.
Hexyl Nicotinate2.0 per cent.
Horse-chestnut (Aesculus)
Hypericum (St. John's Wort)
Hypophosphorous Acid
Isopentane
Labrador Tea
Lactic Acid
Light Liquid Paraffin
Linseed Oil
Mastic
Melaleuca Oil
Methoxymethane
Mexenone
Microcrystalline Wax
Oleyl Alcohol
Paeony (Peony)
Polyethoxyethanol
Potassium Chloride
Potassium Hydroxide
Potassium Thiocyanate
Propylene Glycol
Pyrethrum (Chrysanthemum)
Rue0.1 per cent.
Shark Liver Oil

(1) 3.0 g

(1) Suppositories

(2) All preparations for external use except suppositories

Sodium Acid Pyrophosphate
Sodium Pyrophosphate
Southern Wood
Talc
Tar
Terebene (Terepene)
Thurfyl Salicylate
Titanium Peroxide
Titanium Salicylate
Wool Alcohols, Acetylated
Zinc Oleate

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.

(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.

(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).

(3)

See section 129(6) of the Medicines Act 1968.

(4)

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


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URL: http://www.bailii.org/uk/legis/num_reg/1994/uksi_19942410_en.html