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The Blood Safety and Quality Regulations 2005

Changes over time for: Section 5

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Suspension or revocation of authorisationU.K.

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5.—(1) The Secretary of State may suspend or revoke the authorisation of a blood establishment on one or more of the following grounds—

(a)that the blood establishment has failed, in any material respect, to comply with the requirements of these regulations;

(b)that the collection, testing, processing, storage or distribution of blood or blood components by the establishment cannot be carried out safely;

(c)that any blood or blood components cannot be supplied to hospital blood banks in such a state that they could be safely administered for transfusion; or

(d)that the information given by the blood establishment pursuant to regulation 4(3) was false or incomplete in any material respect.

(2) Subject to paragraph (3), before suspending or revoking the authorisation of a blood establishment, the Secretary of State shall serve a notice on the blood establishment stating that he intends to suspend or revoke its authorisation with effect from the date specified in the notice, which date shall be not less than 7 days from the date on which the notice is served.

(3) Where the Secretary of State considers that it is necessary in the interests of safety, he may, by a notice served on a blood establishment, suspend or revoke its authorisation with immediate effect.

(4) Where—

(a)the blood establishment has failed, in any material respect, to comply with the requirements of these regulations; or

(b)the information given by the blood establishment pursuant to [F1regulation 4(3)] was false or incomplete in any material respect,

and the Secretary of State considers that the failure in question is not sufficiently serious to warrant suspension or revocation of the authorisation of the blood establishment in the first instance, he may serve a notice on the responsible person of the blood establishment in accordance with paragraph (5).

(5) A notice served under this paragraph shall—

(a)identify the requirements of the regulations of which the blood establishment is in breach or, in the case of false and incomplete information, the further information which is required;

(b)identify the action which the blood establishment is required to take; and

(c)give the timescale within which the blood establishment shall take the action identified in sub-paragraph (b).

(6) If the blood establishment fails to comply with the requirements set out in the notice within the specified timescale, the Secretary of State may, by a notice served on the blood establishment, suspend or revoke the authorisation of the blood establishment.

(7) A suspension or revocation pursuant to paragraph (6) shall take effect—

(a)in a case where the Secretary of State considers that it is necessary in the interests of safety, immediately; or

(b)in all other cases, from a date specified in the notice.

(8) Any suspension pursuant to paragraphs (1) or (6) shall be for such period as the Secretary of State shall consider necessary having regard to the reasons for the suspension.

(9) The suspension or revocation of an authorisation under paragraph (1) or paragraph (6) may be total, or may be limited to a particular activity or to one or more activities carried out at a particular site or sites, or to a particular blood component.

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