
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.
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.”.”
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