Amendment of Schedule 5 to the Medicines for Human Use (Marketing Authorisations Etc) Regulations 19942
After paragraph 8 of Schedule 5 to the Medicines for Human Use (Marketing Authorisations Etc) Regulations 1994 (labels)3 insert the following paragraph—
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1
In relation to a relevant medicinal product to which sub-paragraph (2) applies—
a
paragraphs 1 to 7 do not apply; and
b
the container of that product shall be labelled to show—
i
the name of the person to whom the relevant medicinal product is to be administered,
ii
the date on which the relevant medicinal product is dispensed, and
iii
the necessary and usual instructions for proper use.
2
This sub-paragraph applies to a relevant medicinal product which is—
a
an antiviral medicine in the form of a solution which is to be used for the treatment of a child under the age of one year; and
b
sold or supplied for the purpose of treating a disease which is—
i
a serious risk to human health or potentially a serious risk to human health; and
ii
which is pandemic or is imminently pandemic.