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The Blood Safety and Quality Regulations 2005
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- UK Statutory Instruments
- 2005 No. 50
- Regulation 3
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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; and
(b)the processing, storage and distribution of blood and blood components when they are intended to be used for transfusion.
(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; or
(b)any person carrying out any of the activities referred to in paragraph (2), where that person carries out that activity on behalf of, and 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.
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