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The Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2003
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- 2003 No. 1618
- Regulation 3
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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.”.”
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