The Blood Safety and Quality Regulations 2005

Requirement for authorisation U.K.

3.—(1) Subject to paragraph (3), no person may carry on any of the activities listed in paragraph (2) otherwise than in accordance with an authorisation granted under regulation 4.

(2) The activities referred to in paragraph (1) are—

(a) the collection and testing of blood or blood components, whatever their intended purpose; F1 ...

(b) the processing, storage and distribution of blood and blood components when they are intended to be used for transfusion [F2 ; and]

[F3 (c) the import of blood or blood components from a third country;.]

(3) The restriction in paragraph (1) shall not apply to—

(a) the storage and distribution of, and the performance of compatibility tests on, blood and blood components exclusively for use within hospital facilities, including transfusion activities where such activities are performed by a hospital blood bank; F4 ...

(b) any person carrying out any of the activities referred to in paragraph (2), where that person carries out that activity on behalf of, [F5 or pursuant] to a contractual arrangement with—

(i) a blood establishment which is authorised under these regulations to carry out the activity in question; or

(ii) a person responsible for management of a hospital blood bank [F6 ; and]

[F7 (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;]

Textual Amendments

F1 Word in reg. 3(2)(a) omitted (31.8.2006) by virtue of The Blood Safety and Quality (Amendment) Regulations 2006 (S.I. 2006/2013), regs. 1(1), 3(2)(a)

F2 Word in reg. 3(2)(b) inserted (31.8.2006) by The Blood Safety and Quality (Amendment) Regulations 2006 (S.I. 2006/2013), regs. 1(1), 3(2)(b)

F3 Reg. 3(2)(c) inserted (31.8.2006) by The Blood Safety and Quality (Amendment) Regulations 2006 (S.I. 2006/2013), regs. 1(1), 3(2)(c)

F4 Word in reg. 3(3)(a) omitted (31.8.2006) by virtue of The Blood Safety and Quality (Amendment) Regulations 2006 (S.I. 2006/2013), regs. 1(1), 3(3)(a)

F5 Words in reg. 3(3)(b) substituted (31.8.2006) by The Blood Safety and Quality (Amendment) Regulations 2006 (S.I. 2006/2013), regs. 1(1), 3(3)(b)(i)

F6 Word in reg. 3(3)(b) inserted (31.8.2006) by The Blood Safety and Quality (Amendment) Regulations 2006 (S.I. 2006/2013), regs. 1(1), 3(3)(b)(ii)

F7 Reg. 3(3)(c) inserted (31.8.2006) by The Blood Safety and Quality (Amendment) Regulations 2006 (S.I. 2006/2013), regs. 1(1), 3(3)(c)