Statutory Instruments
MEDICINES
Made
8th April 1991
Laid before Parliament
10th April 1991
Coming into force
1st May 1991
The Secretary of State concerned with health in England, theSecretaries of State respectively concerned with health and withagriculture in Wales and in Scotland, the Minister of Agriculture,Fisheries and Food, the Department of Health and Social Services forNorthern Ireland and the Department of Agriculture for Northern Ireland,acting jointly, in exercise of the powers conferred upon them bysections 1(2), 58(1), 129(4) and 132(1) of the Medicines Act 1968(1) or, as the case may be, those conferred by the saidprovisions 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 berepresentative of interests likely to be substantially affected by thisOrder, pursuant to section 129(6) of that Act, and after consulting andtaking into account the advice of the Medicines Commission pursuant tosections 58(6) and 129(7) of that Act, hereby make the followingOrder:—
1. This Order, which may be cited as the Medicines (Products Other ThanVeterinary Drugs) (Prescription Only) Amendment Order 1991, amends theMedicines (Products Other Than Veterinary Drugs) (Prescription Only)Order 1983(3) (hereinafter referred to as“the principal Order”) and shall come into force on 1st May 1991.
2. In article 3(1)(a) of the principal Order (medicinal products onprescription only), after the words“subject to article 4(1)” the words“and (1A)” are deleted and there are inserted the words“, (1A), (1B), (1C) and (1D),”.
3. In article 4 of the principal Order (medicinal products that are notprescription only), the following paragraph is inserted after paragraph(1C):—
“(1D) Notwithstanding Article 3(1)(a), a medicinal product shall notbe a prescription only medicine by reason that it consists of orcontains the substance Hyoscine Butylbromide where—
(a)its route of administration is internal otherwise than by inhaler;
(b)it is sold or supplied in a container or package containing notmore than 240 mg; and
(c)its container or package is labelled to show a maximum daily doseof 80 mg and a maximum dose of 20 mg.”.
4. In Part I of Schedule 1 to the principal Order (which listssubstances which render a medicinal product a prescription only medicineexcept in circumstances also listed)—
(a)the following substances are inserted at the appropriate points inthe alphabetical order of the substances listed in Column 1, and in thecase of Vaccines at the appropriate points in the list ofvaccines,—
Amlodipine Besylate
Anistreplase
Cefuroxime Axetil
Domperidone Maleate
Enoxacin
Flutamide
Isradipine
Levobunolol Hydrochloride
Loxapine Succinate
Metoprolol Succinate
Metoprolol Fumarate
Milrinone Lactate
Nedocromil Sodium
Octreotide
Pamidronate Disodium
Pentamidine Isethionate
Perindopril
Propofol
Quinapril
Teicoplanin
Temocillin Sodium
Terodiline Hydrochloride
Tribavirin
Vaccines – Hepatitis B Vaccine
Meningococcal Polysaccharide Vaccine
Rubella, Mumps, Measles Vaccine
Vigabatrin
Zopiclone
Zuclopenthixol Decanoate;
(b)the entry“Labetolol Hydrochloride” is substituted by the entry“Labetalol Hydrochloride”; and
(c)the entry“Hyoscine Butylbromide” is amended by the deletion in Column 3 (Use, pharmaceutical form orroute of administration) of the words“(b) otherwise than by inhaler”, and in Column 4 (Maximum dose and maximum daily dose) of the words“(b) 3 mg (MD) 9 mg (MDD) (b)”.
5. In Part III of Schedule 1 to the principal Order (medicinalproducts, specified by name and product licence number, which areprescription only medicines), the entry
“Nicorette
0458/0020
0458/0021”
is substituted by the entry
“Nicorette Plus
0458/0021”.
6. In Table A of Part IV of Schedule 1 to the principal Order(medicinal products specified by name and product licence number whichare not prescription only medicines), immediately after the entry“Wasp-Eze Hydrocortisone Cream 0232/0058” the following entry shall be inserted
“Wasp-Eze Hydrocortisone Cream
8452/0012”.
Signed by authority of the Secretary of State for Health.
Virginia Bottomley
Minister of State,
Department of Health
8th April 1991
David Hunt
Secretary of State for Wales
5th April 1991
Signed by authority of the Secretary of State for Scotland.
Allan Stewart
Parliamentary Under-Secretary of State, Scottish Office
8th April 1991
In Witness whereof the Official Seal of the Minister of Agriculture, Fisheries and Food is hereunto affixed on 8th April 1991.
Trumpington
Minister of State, Ministry of Agriculture, Fisheries and Food
Sealed with the Official Seal of the Department of Health and SocialServices for Northern Ireland this eighth day of April 1991.
F. A. Elliott
Permanent Secretary
Sealed with the Official Seal of the Department of Agriculture for Northern Ireland this fifth day of April 1991.
W. J. Hodges
Permanent Secretary
(This note is not part of the Order)
This Order further amends the Medicines (Products Other ThanVeterinary Drugs) (Prescription Only) Order 1983 (the principal Order)which specifies descriptions and classes of prescription only medicinessubject to section 58(2) of the Medicines Act 1968, that is to say,medicinal products which (subject to exemptions) may be sold or suppliedby retail only in accordance with a prescription given by an appropriatepractitioner and which may be administered only by or in accordance withthe directions of such a practitioner.
The amendments made by this Order are as follows:—
Article 2 amends article 3 of the principal Order consequentially onthe changes made to article 4 of the principal Order.
Article 3 amends article 4 of the principal Order which specifiesexemptions from the provisions of section 58(2) so as to exempt certainproducts containing the substance Hyoscine Butylbromide from beingprescription only medicines.
Article 4 amends Part I of Schedule 1 to the principal Order whichlists substances which render medicinal products prescription onlymedicines except in circumstances also listed.
Article 5 amends Part III of Schedule 1 to the principal Order whichlists the name and product licence number of medicinal products whichare prescription only medicines.
Article 6 adds an entry to Part IV of Schedule 1 to the principalOrder which lists the name and product licence number of medicinalproducts which are not prescription only medicines.
1968 c. 67; see the meaning assigned to appropriateMinisters by sections 1(2) and 132(1) and to Ministers by section 1(1).
In the case of the Secretaries of State concerned withhealth in England and in Wales by virtue of article 2(2) of, andSchedule 1 to, the Transfer of Functions (Wales) Order 1969 (S.I.1969/388); in the case of the Secretary of State concerned withagriculture 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); inthe 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, theNorthern Ireland Act 1974 (c. 28).