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Amendment of regulation 3 of the principal Regulations
This section has no associated Explanatory Memorandum
3.—(1) Regulation 3 of the principal Regulations (requirement for authorisation) is amended as follows.
(2) In paragraph (2)—
(a)in sub-paragraph (a), at the end, omit “and”;
(b)in sub-paragraph (b), at the end insert “; and “; and
(c)after sub-paragraph (b), insert the following sub-paragraph—
“(c)the import of blood or blood components from a third country.”.
(3) In paragraph (3)—
(a)in sub-paragraph (a), omit “or”;
(b)in sub-paragraph (b)—
(i)for “and pursuant”, substitute “or pursuant”; and
(ii)at the end, insert “; and”; and
(c)after sub-paragraph (b), insert the following sub-paragraph—
“(c)the import of blood and blood components from a third country when undertaken by—
(i)a manufacturer, or
(ii)a person acting on behalf of and pursuant to a contractual arrangement with a manufacturer,
for the purposes of manufacturing a medicinal product within the meaning of the Medicines act 1968 or the Medical Devices Regulations 2002;”.
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