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Statutory Instrument 1988 No. 2017

The Medicines (Products Other Than Veterinary Drugs) (Prescription Only) Amendment Order 1988

(The document as of February, 2008)

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STATUTORY INSTRUMENTS

1988 No. 2017

MEDICINES

The Medicines (Products Other Than Veterinary Drugs) (Prescription Only) Amendment Order 1988

Made16th November 1988
Laid before Parliament25th November 1988
Coming into force16th December 1988

    The Secretary of State concerned with health in England, the Secretaries of State respectively concerned with health and with agriculture in Wales and in Scotland, the Minister of Agriculture, Fisheries and Food, the Department of Health and Social Services for Northern Ireland and the Department of Agriculture for Northern Ireland, acting jointly, in exercise of powers conferred by sections 58(1), (4) and (5) and 129(4) of the Medicines Act 1968[1], and now vested in them[2] and of all other powers 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 consulting and taking into account the advice of the Medicines Commission pursuant to sections 58(6) and 129(7) of that Act, hereby make the following Order:
    Citation, interpretation and commencement
        1.    This Order, which may be cited as the Medicines (Products Other Than Veterinary Drugs) (Prescription Only) Amendment Order 1988, amends the Medicines (Products Other Than Veterinary Drugs) (Prescription Only) Order 1983[3] (hereinafter referred to as "the principal Order") and shall come into force on 16th December 1988.
    Amendment of article 4 of the principal Order
        2.    In article 4 of the principal Order (medicinal products that are not prescription only) —
       (a) the following paragraph is inserted after paragraph (1A) —
              "(1B)    Notwithstanding Article 3(1)(a), a medicinal product shall not be a prescription only medicine by reason that it consists of or contains the substance astemizole where—
            (a) it is for oral use;
            (b) it is not a sustained release preparation;
            (c) it is sold or supplied in a container or package containing not more than 100mg;
            (d) it is indicated only for the treatment of hay fever in adults or in children over the age of 12 years; and
            (e) its container or package is labelled to show a maximum daily dose of 10mg.";

       (b) the following paragraph is substituted for paragraph (3) —
        "  (3)  Notwithstanding Article 3(1)(d), any preparation of insulin for parenteral administration to human beings shall not be a prescription only medicine.".
    Insertion of article 11A into the principal Order
        3.    The following article is inserted after article 11 of the principal Order:—

        "Exemption in the case of a forged prescription
            11A.    The restrictions imposed by section 58(2)(a) (restrictions on sale and supply) shall not apply to the sale or supply of a prescription only medicine by a pharmacist in accordance with a forged prescription where the pharmacist, having exercised all due diligence, believes on reasonable grounds that the prescription is genuine.".
    Amendment of Part I of Schedule 1 to the principal Order
        4.    In Part I of Schedule 1 to the principal Order (which lists substances which render a medicinal product a prescription only medicine except in circumstances also listed) —
       (a) the following substances are inserted at the appropriate point in the alphabetical order of the substances listed in Column 1—
          "Alclometasone Dipropionate

          Astemizole

          Auranofin

          Buspirone Hydrochloride

          Ciprofloxacin

          Ciprofloxacin Hydrochloride

          Clavulanic Acid

          Danthron

          Desogestrel

          Disodium Etidronate

          Etodolac

          Gemeprost

          Mesalazine

          Metergoline

          Mupirocin

          Nabumetone

          Nicardipine Hydrochloride

          Potassium Clavulanate

          Somatrem

          Sulbactam Sodium

          Thiabendazole

          Trientine Dihydrochloride

          Zidovudine

          Zuclopenthixol Hydrochloride";
       (b) the following substances in Column 1 are deleted —
          "Chlordiazepoxide Hydrochloride

          Etidronate Disodium

          Potassium Clorazepate";
       (c) in Column 3 of the entry relating to Amodiaquine Hydrochloride, the words "Prophylaxis of malaria" are deleted;
       (d) for the entry relating to Ibuprofen there is substituted the entry set out in the Schedule to this Order.
    Amendment of Part III of Schedule 1 to the principal Order
        5.    In Part III of Schedule 1 to the principal Order (medicinal products, specified by name and product licence number, which are prescription only medicines), the following entry is deleted:—

        "Cedocard 20
        0424/0036"
    Amendment of Part IV of Schedule 1 to the principal Order.
        6.    In Part IV of Schedule 1 to the principal Order (specified medicinal products that are not prescription only medicines) —
       (a) the heading "TABLE A" is inserted above the words "NAME AND PRODUCT LICENCE NUMBER OF MEDICINAL PRODUCTS THAT ARE NOT PRESCRIPTION ONLY MEDICINES";
       (b) the following entries are inserted at the appropriate point in the alphabetical order of medicinal products already listed therein —
          "Anflam Cream 0.5%

          0142/0263

          Anflam Ointment 0.5%

          0142/0262

          Dermacort Hydrocortisone Cream

          8265/0002".
       (c) the following Table is inserted at the end of the list of medicinal products already listed therein —

          TABLE B
          "RELEVANT PRODUCT LICENCE HOLDER AND NAME AND PRODUCT LICENCE NUMBER OF MEDICINAL PRODUCTS THAT ARE NOT PRESCRIPTION ONLY MEDICINES

          Leo Laboratories Limited:

          Hydrocortisone Acetate Cream BP 0.5%

          — 0043/0150

          Hydrocortisone Acetate Cream BP 1.0%

          0043/0151
            Richard Daniel and Son Limited:
              Hydrocortisone Cream BP 1.0%

              — 0842/0011



Signed by authority of the Secretary of State for Health.

D. Mellor

Minister of State, Department of Health

7th November 1988

Peter Walker

Secretary of State for Wales

9th November 1988

Malcolm Rifkind

Secretary of State for Scotland

10th November 1988
In Witness whereof the Official Seal of the Minister of Agriculture, Fisheries and Food is hereunto affixed on 16th November 1988.

John MacGregor

Minister of Agriculture, Fisheries and Food

Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland this 14th day of November 1988.

F. A. Elliott

Permanent Secretary

Sealed with the Official Seal of the Department of Agriculture for Northern Ireland this 14th day of November 1988.

W. H. Jack

Permanent Secretary





Notes:

[1] 1968 c. 67; by virtue of section 132(1) of that Act the expression "the appropriate Ministers" is to be construed in accordance with section 1(2) thereof.

[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 Secretary of State concerned with agriculture in Wales by virtue of article 2(3) of, and Schedule 1 to, the Transfer of Functions (Wales) (No. 1) Order 1978 (S.I. 1978/272); in the case of the Northern Ireland Departments 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] S.I. 1983/1212, as amended by S.I. 1984/756, 1986/586 and 1987/674 and 1250.

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