Statutory Instruments
2001 No. 3942
MEDICINES
The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2001
Made
9th December 2001
Laid before Parliament
10th December 2001
Coming into force
31st December 2001
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 1968( 1 ) or, as the case may be, the powers 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, 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 interpretation
1. —(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 1997( 3 );
Amendment of Schedule 1 to the principal Order
2. 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
9th December 2001
Bairbre de Brún
Minister of Health, Social Services and Public Safety
6th December 2001
1968 c. 67 ; the expression “the appropriate Ministers”, and the expression “the Health Ministers” which is relevant to the powers being exercised in the making of this Order, are defined in section 1 of that Act as amended by article 2(2) of, and Schedule 1 to, S.I. 1969/388 , and by articles 2(1) and 5 of, and the Schedule to, S.I. 1999/3142 ; section 58 was amended by section 1 of the Prescription by Nurses etc. Act 1992 (c. 28) and by section 63 of the Health and Social Care Act 2001 (c. 15) .
In the case of the Secretary of State concerned with health in England, by virtue of article 2(2) of, and Schedule 1 to, S.I. 1969/388 , and articles 2(1) and 5 of, and the Schedule to, S.I. 1999/3142 ; and in the case of the Minister of Health, Social Services and Public Safety, by virtue of section 95(5) of, and paragraph 10 of Schedule 12 to, the Northern Ireland Act 1998 (c. 47) .