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The Medicines for Human Use (Marketing Authorisation Etc.) Amendment Regulations 1998

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Insertion of Schedule 5A to the principal Regulations

4.  After Schedule 5 to the principal Regulations (labels), there shall be inserted the following Schedule—

Regulation 11

SCHEDULE 5ALEAFLETS

1.  Where in accordance with the relevant Community provisions a package leaflet is included in the packaging of a relevant medicinal product containing paracetamol, unless the product is wholly or mainly intended for children who are twelve years old or younger the leaflet shall display the words “Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage”.

2.  Where in accordance with the relevant Community provisions a package leaflet is included in the packaging of a relevant medicinal product containing paracetamol and the product is wholly or mainly intended for children who are twelve years old or younger, the leaflet shall display the words “Immediate medical advice should be sought in the event of an overdose, even if the child seems well, because of the risk of delayed, serious liver damage”.

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