Regulation 3 Amendment of regulation 3 of the principal Regulations

(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;”.