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

Amendment of Schedule 5 to the principal Regulations

3.—(1) After paragraph 5(1)(e) of Schedule 5 to the principal Regulations (labels—relevant medicinal products on a general sale list), there shall be added the following—

“(f) if the product contains paracetamol, unless it is wholly or mainly intended for children who are twelve years old or younger, the words “Do not take with any other paracetamol—con taining products”, and

(i) if a package leaflet accompanying the product displays the words set out in quotation marks in paragraph 1 of Schedule 5A, the words “Immediate medical advice should be sought in the case of an overdose, even if you feel well”, or

(ii) if no package leaflet accompanies the product or the package leaflet does not display the words in paragraph 1 of Schedule 5A, 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”;

(g) if the product contains paracetamol and is wholly or mainly intended for children who are twelve years old or younger, the words “Do not give with any other paracetamol—containing products”; and

(i) if a package leaflet accompanying the product displays the words set out in quotation marks in paragraph 2 of Schedule 5A, the words “Immediate medical advice should be sought in the case of an overdose, even if the child seems well”, or

(ii) if no package leaflet accompanies the product or the package leaflet does not display the words in paragraph 2 of Schedule 5A, 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”.”

(2) In paragraph 5(2)(b) of Schedule 5 to the principal Regulations (labels—relevant medicinal products on a general sale list), after the words “of those sub-paragraphs” there shall be inserted the words “or sub-paragraph (1)(f) or (g)”.