The Blood Safety and Quality (Amendment) Regulations 2006

Amendment of regulation 3 of the principal Regulations

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;”.