2001 No. 3942
MEDICINES

The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2001

Made
Laid before Parliament
Coming into force
As respects England, Scotland and Wales, the Secretary of State concerned with health in England, and, as respects Northern Ireland, the Minister of Health, Social Services and Public Safety, acting jointly, in exercise of the powers conferred on them by sections 58(1), (4) and (5), 59 and 129(4) of the Medicines Act 19681 or, as the case may be, the powers conferred by those provisions and now vested in them2, 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 taking into account the advice of the Committee on Safety of Medicines and the Medicines Commission pursuant to section 129(7) of that Act, hereby make the following Order:—

Citation, commencement and interpretation1.

(1)

This Order may be cited as the Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2001 and shall come into force on 31st December 2001.

(2)

In this Order, “the principal Order” means the Prescription Only Medicines (Human Use) Order 19973;

Amendment of Schedule 1 to the principal Order2.

In Schedule 1 to the principal Order (which specifies substances which if included in medicinal products make those products prescription only medicines and exemptions from restrictions on the sale and supply of prescription only medicines)—

(a)

in relation to the substance Cetirizine Hydrochloride, the entry in column 5 is deleted;

(b)

in relation to the substance Flurbiprofen—

(i)

in column 2, there is inserted “8.75 mg”;

(ii)

in column 3, there is inserted “Throat lozenges”;

(iii)

in column 4, there is inserted “43.75 mg (MDD)”; and

(iv)

in column 5, there is inserted “Container or package containing not more than 140 mg of Flurbiprofen”;

(c)

in relation to the substance Loratadine, the entry in column 5 is deleted;

(d)

in relation to the substance Terbinafine—

(i)

in column 2, there is inserted “1.0 per cent”;

(ii)

in column 3, there is inserted “External use for the treatment of tinea pedis, tinea cruris and tinea corporis. In the form of a gel”; and

(iii)

in column 5, there is inserted “Container or package containing not more than 30 grams of medicinal product”;

(e)

there is inserted in column 1, at the appropriate place in the alphabetical order of the entries as they appear in that column, the entries set out in column 1 in the Table below, and, against those entries, there is inserted in columns 2, 3, 4 and 5 the corresponding text in columns 2, 3, 4 and 5 below:

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Maximum strength

Route of administration, use, or pharmaceutical form

Treatment limitations

Maximum quantity

Diphenoxylate Hydrochloride

2.5 mg

In combination with Atropine Sulphate for short term use as an adjunctive therapy to appropriate rehydration in acute diarrhoea

25 mg (MDD)

Container or package containing not more than 20 tablets

For use in persons aged 16 years and over

Tablets

Dolasetron Mesilate

Ropinirole Hydrochloride

Signed by authority of the Secretary of State for Health

Hunt
Parliamentary Under Secretary of State,
Department of Health
Bairbre de Brún
Minister of Health, Social Services and Public Safety
(This note is not part of the Order)

This Order further amends the Prescription Only Medicines (Human Use) Order 1997 (“the principal Order”).

Article 2 amends Schedule 1 to the principal Order (which specifies substances which, if included in medicinal products, make them prescription only medicines, and exemptions from the restrictions in section 58(2) on sale and supply of prescription only medicines):

(a)

in respect of the entries for Cetirizine Hydrochloride and Loratadine to provide that medicinal products containing these substances may be sold or supplied otherwise than as prescription only medicines without any restriction on the maximum quantity in a container or package;

(b)

in respect of the entries for Flurbiprofen and Terbinafine to provide that medicinal products containing these substances may be sold or supplied otherwise than as prescription only medicines on the conditions specified;

(c)

to insert an entry for Diphenoxylate Hydrochloride and to provide that medicinal products containing Diphenoxylate Hydrochloride may be sold or supplied otherwise than as a prescription only medicine with Atropine Sulphate on the conditions specified;

(d)

to insert entries for the substances Dolasetron Mesilate and Ropinirole Hydrochloride.

An assessment of the cost to business of complying with this Order has been made, copies of which have been placed in the libraries of both Houses of Parliament. Further copies may be obtained from the Department of Health, Medicines Control Agency, Information Centre, Room 10–202, Market Towers, 1 Nine Elms Lane, London SW8 5NQ.