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The Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2003
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- 2003 No. 1618
- Explanatory Note
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Explanatory Note
(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.
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