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STATUTORY INSTRUMENTS
1991No. 962
MEDICINES
The Medicines (Products Other Than Veterinary Drugs) (Prescription
Only) Amendment Order 1991
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, 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 the powers conferred upon them by
sections 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 said
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, 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, commencement and interpretation
1. This Order, which may be cited as the Medicines (Products Other Than
Veterinary Drugs) (Prescription Only) Amendment Order 1991, 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 1st May 1991.
Amendment of article 3 of the principal Order
2. In article 3(1)(a) of the principal Order (medicinal products on
prescription 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),"
.
Amendment of article 4 of the principal Order
3. In article 4 of the principal Order (medicinal products that are not
prescription only), the following paragraph is inserted after paragraph
(1C):—
" (1D) 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 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 not
more than 240 mg; and
(c) its container or package is labelled to show a maximum daily dose
of 80 mg and a maximum dose of 20 mg."
.
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 points in
the alphabetical order of the substances listed in Column 1, and in the
case of Vaccines at the appropriate points in the list of
vaccines,—
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 or
route 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)"
.
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 entry
"Nicorette 0458/0020 0458/0021"
is substituted by the entry
"Nicorette Plus 0458/0021"
.
Amendment of Table A of Part IV of Schedule 1 to the principal
Order
6. In Table A of Part IV of Schedule 1 to the principal Order
(medicinal products specified by name and product licence number which
are 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 Social
Services 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.
This Order further amends the Medicines (Products Other Than
Veterinary Drugs) (Prescription Only) Order 1983 (the principal Order)
which specifies descriptions and classes of prescription only medicines
subject to section 58(2) of the Medicines Act 1968, that is to say,
medicinal products which (subject to exemptions) may be sold or supplied
by retail only in accordance with a prescription given by an appropriate
practitioner and which may be administered only by or in accordance with
the directions of such a practitioner.
The amendments made by this Order are as follows:—
Article 2 amends article 3 of the principal Order consequentially on
the changes made to article 4 of the principal Order.
Article 3 amends article 4 of the principal Order which specifies
exemptions from the provisions of section 58(2) so as to exempt certain
products containing the substance Hyoscine Butylbromide from being
prescription only medicines.
Article 4 amends Part I of Schedule 1 to the principal Order which
lists substances which render medicinal products prescription only
medicines except in circumstances also listed.
Article 5 amends Part III of Schedule 1 to the principal Order which
lists the name and product licence number of medicinal products which
are prescription only medicines.
Article 6 adds an entry to Part IV of Schedule 1 to the principal
Order which lists the name and product licence number of medicinal
products which are not prescription only medicines.
ISBN 0 11 013962 3
Notes:
[1] 1968 c. 67; see the meaning assigned to appropriate
Ministers by sections 1(2) and 132(1) and to Ministers by section 1(1). back
[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). back