Statutory Instruments
MEDICINES
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:
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.
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;”.
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)
| Column 1 | Column 2 | Column 3 | Column 4 |
|---|---|---|---|
| Substance | Maximum strength | Use, pharmaceutical form or route of administration | Maximum 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 | |||
| Betacarotene | 6 mg (MDD) | ||
| Bismuth Aluminate | 6 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 Sulphate | Equivalent 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 Chloride | Equivalent to 24 mg elemental iron (MD) | ||
| Fibre, Vegetable | |||
| Fig | |||
| Fir Oil, Siberian | |||
| Frangulin | |||
| Fringe Tree | |||
| Fumitory | 160 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 | |||
| Kava | 625 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 Glycerophosphate | Equivalent 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 Molybdate | Equivalent to 200 mcg elemental molybdenum (MDD) | ||
| Psyllium | |||
| Queen’s Delight | 320 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 Gluconate | Equivalent to 5 mg elemental zinc (MDD) |
Article 3(3)(a)
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| Substance | Maximum Strength | Use, 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 Acid | 2.5 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 | ||
| Halquinol | 0.6 per cent. | |
| Heparin | ||
| Hexetidine | 0.1 per cent. | |
| Hexyl Nicotinate | 2.0 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) | ||
| Rue | 0.1 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 |
(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.
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.
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).
See section 129(6) of the Medicines Act 1968.