The Blood Safety and Quality Regulations 2005

Objections to suspensions, revocations etc

12.—(1) A blood establishment or a person responsible for the management of a hospital blood bank who—

(a) objects to any suspension or revocation of authorisation, or to any notice served pursuant to regulation 4(8), 5 or 11; or

(b) objects to the refusal of authorisation or the imposition of any condition pursuant to regulation 4(5),

may notify the Secretary of State of its desire to make written representations to, or be or appear before and be heard by, a person appointed by the Secretary of State for that purpose.

(2) Any notification of an objection pursuant to paragraph 1 shall be made within 14 days of service on the blood establishment or the person responsible for the management of the hospital blood bank of the notice to which the notification pursuant to paragraph (1) relates.

(3) Where the Secretary of State receives a notification pursuant to paragraph (1), he shall appoint a person to consider the matter.

(4) The person appointed pursuant to paragraph (3) shall determine the procedure to be followed with respect to the consideration of any objection.

(5) The person appointed pursuant to paragraph (3) shall consider any written or oral objections made by the blood establishment or the person responsible for management of the hospital blood bank in support of its objection, and shall make a recommendation to the Secretary of State.

(6) A recommendation made pursuant to paragraph (5) shall be made in writing to the Secretary of State, and a copy of it shall be sent to the blood establishment or the person responsible for the management of the hospital blood bank concerned, or to its nominated representative.

(7) The Secretary of State shall take into account any recommendation made pursuant to paragraph (5).

(8) Within 14 days of receipt of any recommendation made pursuant to paragraph (5), the Secretary of State shall inform the blood establishment or the person responsible for the management of the hospital blood bank whether he accepts the recommendation and, if he does not accept it, of the reasons for his decision.

(9) Where the Secretary of State is notified of an objection pursuant to paragraph (1)(a) before the date upon which the suspension or revocation or the notice is due to take effect, the suspension or revocation or notice in respect of which the objection is made shall not take effect until—

(a) the person appointed pursuant to regulation (3) has considered the matter in accordance with the provisions of this regulation and made a recommendation; and

(b) the Secretary of State has informed the blood establishment or the person responsible for the management of the hospital blood bank concerned of his decision with regard to the recommendation pursuant to paragraph (8),.

(10) Subject to paragraph (11), where the Secretary of State is notified of an objection pursuant to paragraph (1)(a), within the period specified in paragraph (2), to a suspension, revocation or other notice which has already taken effect on the date the notification was made, the suspension, revocation or notice in respect of which the objection is made shall cease to have effect until—

(a) the person appointed pursuant to regulation (3) has considered the matter in accordance with the provisions of this regulation and made a recommendation; and

(b) the Secretary of State has informed the blood establishment or the person responsible for the management of the hospital blood bank concerned of his decision with regard to the recommendation pursuant to paragraph (8).

(11) Paragraph (10) shall not apply—

(a) in relation to a suspension or revocation, or a notice served pursuant to regulation 11, which takes immediate effect in accordance with regulation 5(3) or 11(3); or

(b) in any other case, where the Secretary of State determines that it is necessary in the interests of public safety for the suspension, revocation or notice to take effect on the date originally specified, and serves a notice in writing to that effect on the blood establishment or person responsible for management of the hospital blood bank concerned.