- Statutory Instrument 2003 No. 1618
The Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2003
© Crown Copyright 2003
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 Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2003, ISBN 0110466357. 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 | 20th June 2003 | ||
| Laid before Parliament | 27th June 2003 | ||
| Coming into force | 1st October 2003 |
The Secretary of State, being a Minister designated for the purposes of section 2(2) of the European Communities Act 1972[1] in relation to medicinal products[2], in exercise of the powers conferred by the said section 2(2), and of all other powers enabling him in that behalf, hereby makes the following Regulations: -
Citation, commencement and interpretation
1. - (1) These Regulations may be cited as the Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2003 and shall come into force on 1st October 2003.
(2) In these Regulations, "the principal Regulations" means the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994[3].
Amendment of Schedule 5 to the principal Regulations
2. After paragraph 5(1)(g) of Schedule 5 to the principal Regulations (labels - relevant medicinal products on a general sale list), there shall be added the following head -
-
"
(h) if the product contains aspirin or aloxiprin, the words "Do not give to children aged under 16 years, unless on the advice of a doctor."."
Amendment of Schedule 5A to the principal Regulations
3.
After paragraph 2 of Schedule 5A to the principal Regulations (leaflets), there shall be added the following paragraph -
-
"
3.
Where in accordance with the relevant Community provisions a package leaflet is included in the packaging of a relevant medicinal product containing aspirin or aloxiprin, the leaflet shall display the words "There is a possible association between aspirin and Reye's syndrome when given to children. Reye's syndrome is a very rare disease, which can be fatal. For this reason aspirin should not be given to children aged under 16 years, unless on the advice of a doctor."."
Signed by authority of the Secretary of State for Health
Warner
Parliamentary Under Secretary of State Department of Health
20th June 2003
(This note is not part of the Regulations)
These Regulations amend the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 ("the principal Regulations") which implement Council Directive 2001/83/EEC (O.J. No. L311 of 28.11.2001) by requiring necessary special warnings to be included on the packaging of relevant medicinal products containing aspirin or aloxiprin, and in package leaflets accompanying those products.
A Regulatory Impact Assessment in relation to these Regulations has been placed in the libraries of both Houses of Parliament, and copies can be obtained from the Medicines and Healthcare Products Regulatory Agency, Market Towers, 1 Nine Elms Lane, London SW8 5NQ.
Notes:
[1] 1972 c.68.back
[3] S.I. 1994/3144; the relevant amending instruments are S.I. 1998/3105 and 2000/292.back
ISBN 0 11 046635 7