The Human Medicines Regulations 2012

[F1 Criteria of broker’s registration U.K.

45E.— (1) Registration of a broker is conditional on that broker—

(a) complying with regulation 45A(1); and

(b) satisfying—

(i) the criteria in paragraphs (3), (4) and (7), and

(ii) such other criteria as the licensing authority considers appropriate and notifies the broker of.

(2) The criteria referred to in paragraph (1)(b)(ii) may include (but are not limited to) the criteria specified in paragraphs (5) and (6).

(3) The broker must—

(a) have a permanent address in the United Kingdom;

(b) maintain an emergency plan to ensure effective implementation of the recall from the market of a medicinal product where recall is—

[F2 (i) ordered by—

(aa) in the case of a broker in Great Britain, the licensing authority or by an appropriate authority responsible for the licensing of medicinal products in an approved country for import, or

(bb) in the case of a broker in Northern Ireland, the licensing authority or by the competent authority of any EEA State, or]

(ii) carried out in co-operation with the manufacturer of, or the holder of the marketing authorisation, for the product;

(c) keep documents relating to the sale or supply of medicinal products under the licence which may facilitate the withdrawal or recall from sale of medicinal products in accordance with sub-paragraph (b);

(d) record in relation to the brokering of each medicinal product—

(i) the name of the medicinal product,

(ii) the quantity of the product brokered,

(iii) [F3 where the sale or supply of the medicinal product is in Northern Ireland,] the batch number of the medicinal product bearing the safety features referred to in point (o) of Article 54 of the 2001 Directive,

(iv) the name and address of the—

(aa) supplier, or

(bb) consignee, and

(v) the date on which the sale or purchase of the product is brokered;

(e) maintain a quality system setting out responsibilities, processes and risk management measures in relation to their activities; and

(f) keep the documents or record required by sub-paragraph (c) or (d) available to the licensing authority for a period of five years; and

(g) comply with regulation 45F(1), (2) and (4).

(4) Where the address at which the plan or records necessary to comply with paragraph (3)(b) to (d) are kept is different from the address notified in accordance with regulation 45B(2)(c)(i), the broker must—

(a) ensure that the plan or records are kept at an address in the United Kingdom; and

(b) inform the licensing authority of the address at which the plan or records are kept.

(5) The broker must provide such information as may be requested by the licensing authority concerning the type and quantity of medicinal products brokered within the period specified by the licensing authority.

(6) The broker must take all reasonable precautions and exercise all due diligence to ensure that any information provided by that broker to the licensing authority in accordance with regulation 45F is not false or misleading.

(7) For the purposes of enabling the licensing authority to determine whether there are grounds for suspending, revoking or varying the registration, the broker must permit a person authorised in writing by the licensing authority, on production of identification, to carry out any inspection, or to take any copies, which an inspector may carry out or take under regulations 325 (rights of entry) and 327 (powers of inspection, sampling and seizure).]

Textual Amendments

F1 Pt. 3 Chs. 3, 4 inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 16

F2 Reg. 45E(3)(b)(i) substituted (31.12.2020) by S.I. 2019/775, regs. 1, 40(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 29(a))

F3 Words in reg. 45E(3)(d)(iii) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 40(b) (as substituted by S.I. 2020/1488, reg. 1, Sch. 2 para. 29(b)); 2020 c. 1, Sch. 5 para. 1(1)