- Statutory Instrument 1997 No. 2044
The Prescription Only Medicines (Human Use) Amendment Order 1997
© Crown Copyright 1997
Statutory Instruments printed from this website are printed under the superintendence and authority of the Controller of HMSO being the Queen's Printer of Acts of Parliament.
The legislation contained on this web site is subject to Crown Copyright protection. It may be reproduced free of charge provided that it is reproduced accurately and that the source and copyright status of the material is made evident to users.
It should be noted that the right to reproduce the text of Statutory Instruments does not extend to the Queen's Printer imprints which should be removed from any copies of the Statutory Instrument which are issued or made available to the public. This includes reproduction of the Statutory Instrument on the Internet and on intranet sites. The Royal Arms may be reproduced only where they are an integral part of the original document.
The text of this Internet version of the Statutory Instrument which is published by the Queen's Printer of Acts of Parliament has been prepared to reflect the text as it was Made. A print version is also available and is published by The Stationery Office Limited as the The Prescription Only Medicines (Human Use) Amendment Order 1997 , ISBN 0 11 064858 7. The print version may be purchased by clicking here. Braille copies of this Statutory Instrument can also be purchased at the same price as the print edition by contacting TSO Customer Services on 0870 600 5522 or e-mail:customer.services@tso.co.uk.
Further information about the publication of legislation on this website can be found by referring to the Frequently Asked Questions.
To ensure fast access over slow connections, large documents have been segmented into "chunks". Where you see a "continue" button at the bottom of the page of text, this indicates that there is another chunk of text available.
| Made | 26th August 1997 | ||
| Laid before Parliament | 26th August 1997 | ||
| Coming into force | |||
| except for article 2(c) | 16th September 1997 | ||
| article 2(c) | 16th September 1998 |
The Secretaries of State concerned with health in England, in Wales and in Scotland respectively and the Department of Health and Social Services for Northern Ireland, acting jointly, in exercise of powers conferred on them by sections 58(1), (4) and (5) and 129(4) 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. - (1) This Order may be cited as the Prescription Only Medicines (Human Use) Amendment Order 1997 and shall come into force on 16th September 1997 except for article 2(c) which shall come into force on 16th September 1998.
(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 the entry for "Carbenoxolone Sodium", there is substituted for "506mg" in column 5, "560mg";
(b) the entry for "Terfenadine" is amended by the deletion of the entries "120mg (MDD)" in column 4 and "Container or package containing not more than 1,200mg of Terfenadine" in column 5; and
(c) there are inserted in column 1 and, as the case may be, columns 2, 3 and 5, at the appropriate point in the alphabetical order of the entries as they appear in column 1, each of the entries set out in column 1 of Schedule 1 to this Order, together with the corresponding text in columns 2, 3 and 5 respectively of that Schedule.
Frank Dobson,
Secretary of State for Health
12th August 1997
Win Griffiths,
Parliamentary Under-Secretary of State,Welsh Office
20th August 1997
Sam Galbraith,
Parliamentary Under-Secretary of State,The Scottish Office
26th August 1997
Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland on
L.S.
D. C. Gowdy,
Permanent Secretary
20th August 1997.
| Column 1 | Column 2 | Column 3 | Column 4 | Column 5 |
| Substance | Maximum strength | Route of administration, use or pharmaceutical form | Treatment limitations | Maximum quantity |
| Aspirin |
(1) 325 mg |
(1) Non-effervescent tablets and capsules (2) All preparations other than non-effervescent tablets or capsules |
(1) The quantity sold or supplied in one container or package shall not exceed 32 The quantity of non-effervescent tablets, capsules or a combination of both sold or supplied to a person at any one time shall not exceed 100 |
|
| Paracetamol |
(1) 120 mg |
(1) Non-effervescent tablets and capsules for use in children aged less than 12 years |
(1) The quantity sold or supplied in one container or package shall not exceed 32 The quantity of non-effervescent tablets, capsules or a combination of both sold or supplied to a person at any one time shall not exceed 100 |
|
|
(2) 500 mg |
(2) Non-effervescent tablets and capsules for use in adults and children not less than 12 years (3) All preparations other than non-effervescent tablets and capsules |
(2) The quantity sold or supplied in one container or package shall not exceed 32 The quantity of non-effervescent tablets, capsules or a combination of both sold or supplied to a person at any one time shall not exceed 100 |
(This note is not part of the Order)
This Order amends the Prescription Only Medicines (Human Use) Order 1997 ("the principal Order") which specifies descriptions and classes of prescription only medicines (i.e. 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). Under the principal Order products are included in a class of such medicines by reason of the substances contained in them, subject to their being excluded in specified circumstances.
Article 2 of this Order amends Schedule 1 to the principal Order, which lists substances which render a medicinal product a prescription only medicine except in the circumstances also listed. The entry for carbenoxolone sodium is amended with effect from 16th September 1997 as to the conditions under which that substance may be sold otherwise than as a prescription only medicine. The entry for terfenadine is amended so that with effect from 16th September 1997 all products containing that substance are prescription only medicines. With effect from 16th September 1998 medicinal products which contain the analgesics aspirin or paracetamol are included in that Schedule with provisions to exempt certain products containing those substances and quantities of such products from being prescription only medicines.
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 1207 Market Towers, 1 Nine Elms Lane, London SW8 5NQ.
Notes:
[1] 1968 c. 67. The expressions "the appropriate Ministers" and "the Health Ministers" are defined in section 1 of that Act as amended by S.I. 1969/388, Schedule 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 Department of Health and Social Services for Northern Ireland 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
ISBN 0 11 064858 7