The Human Medicines Regulations 2012

[F1 CHAPTER 3 U.K. Brokering

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

Brokering in medicinal products U.K.

45A.— [F2 (1) A person may not broker a medicinal product in Great Britain unless—

(a) the product is covered by an authorisation granted—

(i) by the licensing authority, or

(ii) by an appropriate authority responsible for the licensing of medicinal products in an approved country for import, and

(b) that person—

(i) is validly registered as a broker with the licensing authority,

(ii) has a permanent address in the United Kingdom, and

(iii) complies with the guidelines on good distribution practice which apply under, or by virtue of, regulation C17 insofar as those guidelines apply to brokers.

(1A) A person may not broker a medicinal product in Northern Ireland unless—

(a) the product is covered by an authorisation granted—

(i) under Regulation (EC) No 726/2004,

(ii) by the licensing authority, or

(iii) by a competent authority of a member State, and

(b) that person—

(i) is validly registered as a broker with the licensing authority or a competent authority of a member State,

(ii) except where the person is validly registered with the competent authority of an EEA State, has a permanent address in the United Kingdom, and

(iii) complies with the guidelines on good distribution practice published by the European Commission in accordance with Article 84 of the 2001 Directive insofar as those guidelines apply to brokers.]

(2) A person is not validly registered for the purpose of paragraph (1)(b) [F3 or (1A)(b)] if—

(a) the person’s permanent address is not entered into a register of brokers kept by a competent authority of a member State [F4 or the licensing authority (as appropriate)];

(b) the registration is suspended; or

(c) the person has notified the competent authority of a member State [F5 or the licensing authority (as appropriate)] to remove that person from the register.

F6 (3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F2 Reg. 45A(1)(1A) substituted for reg. 45A(1) (31.12.2020) by S.I. 2019/775, regs. 1, 38(2) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 28(a))

F3 Words in reg. 45A(2) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 38(3)(a) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 28(b)); 2020 c. 1, Sch. 5 para. 1(1)

F4 Words in reg. 45A(2)(a) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 38(3)(b) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 28(b)); 2020 c. 1, Sch. 5 para. 1(1)

F5 Words in reg. 45A(2)(c) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 38(3)(b) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 28(b)); 2020 c. 1, Sch. 5 para. 1(1)

F6 Reg. 45A(3) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 38(4); 2020 c. 1, Sch. 5 para. 1(1)

Application for brokering registration U.K.

45B.— (1) The licensing authority may not register a person as a broker unless paragraphs [F7 (2)] to (7) are complied with.

(2) An application for registration must be made containing—

(a) the name of the person to be registered;

(b) the name under which that person is trading (if different to the name of that person);

(c) that person’s—

(i) permanent address in the United Kingdom,

(ii) e-mail address, and

(iii) telephone number;

(d) a statement of whether the medicinal products to be brokered are—

(i) prescription only medicines,

(ii) pharmacy medicines, or

(iii) medicines subject to general sale;

(e) an indication of the range of medicinal products to be brokered;

(f) evidence that that person can comply with regulations 45A(1)(b)(iii), 45E(3)(a) to (f) and 45F(1); and

(g) any fee payable in connection with the application in accordance with the Fees Regulations.

(3) Where the address at which the emergency plan, documents or record necessary to comply with regulation 45E(3)(b) to (d) are kept is different from the address notified in accordance with sub-paragraph (2)(c)(i), the application must contain—

(a) that address where the plan or records are to be kept;

(b) the name of a person who can provide access to that address for the purpose of regulation 325 (rights of entry); and

(c) that person’s—

(i) address,

(ii) e-mail address, and

(iii) telephone number.

(4) Unless paragraph (6) applies, the application for registration must—

(a) be in English; and

(b) be signed by the person seeking a brokering registration.

(5) The pages of the application must be serially numbered.

(6) Where the application is made on behalf of the person seeking a brokering registration by another person (“A”), the application must—

(a) contain the name and address of A; and

(b) be signed by A.

Textual Amendments

F7 Word in reg. 45B(1) inserted (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.I. 2017/715), regs. 1, 4 and word in reg. 45B(1) inserted (N.I.) (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.R. 2017/241), regs. 1, 4

Procedure for determining an application for broker’s registration U.K.

45C.— (1) The licensing authority must grant or refuse an application for registration under regulation 45B within the period of 90 days beginning immediately after the day on which it receives the application.

(2) Paragraph (1) applies to an application only if the requirements of regulation 45B(2) have been met.

(3) Before determining an application for a brokering registration, the licensing authority may notify the applicant of a requirement to provide such information as the licensing authority thinks necessary, within the period specified by the licensing authority.

(4) If a notice under paragraph (3) requires the applicant to provide the licensing authority with information, the information period is not to be counted for the purposes of paragraph (1).

(5) In paragraph (4), the “information period” means the period—

(a) beginning with the day on which the notice is given, and

(b) ending with the day on which the licensing authority receives the information or the applicant shows to the licensing authority’s satisfaction that the applicant is unable to provide it.

Grant or refusal of broker’s registration U.K.

45D.— (1) Subject to regulations 45E and 45F, on an application to the licensing authority for a brokering registration, the licensing authority must, if it considers it necessary and appropriate to do so—

(a) register the applicant as a broker; or

(b) refuse registration as a broker, having regard to—

(i) the provisions of these Regulations, F8 ...

F8 (ii) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(2) The licensing authority must give the applicant a notice stating the reasons for its decision in any case where the licensing authority—

(a) refuses to grant an application for registration; or

(b) grants registration otherwise than in accordance with the application and the applicant requests a statement of its reasons.

(3) The licensing authority must register the applicant or refuse registration under this Chapter within the period of 90 days beginning immediately after the day on which it receives the application.

(4) Where the licensing authority registers a person as a broker, the licensing authority must enter the following information into a publicly available register—

(a) the person’s name;

(b) the name under which that person is trading (if different from the person’s name);

(c) the person’s permanent address in the United Kingdom.

(5) The licensing authority must make the register of brokers publicly available.

Textual Amendments

F8 Reg. 45D(1)(b)(ii) and word omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 39; 2020 c. 1, Sch. 5 para. 1(1)

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—

[F9 (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) [F10 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

F9 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))

F10 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)

Provision of information U.K.

45F.— (1) A broker registered in the UK must immediately inform—

(a) the licensing authority; and

[F11 (b) in the case of a broker in—

(i) Great Britain, either—

(aa) the UK marketing authorisation holder, or

(bb) where applicable, the holder of the licence or authorisation granted by an appropriate authority responsible for the licensing of medicinal products in an approved country for import, or

(ii) Northern Ireland, either—

(aa) the UK marketing authorisation holder, or

(bb) where applicable, the EU marketing authorisation holder,]

of medicinal products which the broker identifies as, suspects to be, or has reasonable grounds for knowing or suspecting to be, falsified.

(2) On or before the date specified in paragraph (3), a broker who is, or has applied to the licensing authority to become, a registered broker in the United Kingdom must submit a report to the licensing authority, which—

(a) includes a declaration that the broker has in place an appropriate system to ensure compliance with regulations 45A, 45B and this regulation; and

(b) details the system which the broker has in place to ensure such compliance.

(3) The date specified for the purposes of this paragraph is—

(a) in relation to any application made before 31st March 2014, the date of the application; and

(b) in relation to each subsequent reporting year, 30th April following the end of that year.

(4) The broker must without delay notify the licensing authority of any changes to the matters in respect of which evidence has been supplied in relation to paragraph (2) which might affect compliance with the requirements of this Chapter.

(5) Any report or notification to the licensing authority under paragraph (2) or (4) must be accompanied by the appropriate fee in accordance with the Fees Regulations.

(6) The licensing authority may give a notice to a registered broker requiring that broker to provide information of a kind specified in the notice within the period specified in the notice.

(7) A notice under paragraph (6) may not be given to a registered broker unless it appears to the licensing authority that it is necessary for the licensing authority to consider whether the registration should be varied, suspended or revoked.

(8) A notice under paragraph (6) may specify information which the licensing authority thinks necessary for considering whether the registration should be varied, suspended or revoked.

(9) In paragraph (3)(b), “reporting year” means a period of twelve months ending on 31st March.

Textual Amendments

F11 Reg. 45F(1)(b) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 41 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 30); 2020 c. 1, Sch. 5 para. 1(1)

Power to suspend or vary a broker’s registration or remove a broker from the register U.K.

45G.— (1) The licensing authority may in accordance with regulation 45H—

(a) suspend a broker’s registration for such period as the authority thinks fit;

(b) vary a broker’s registration; or

(c) remove a person from the register.

(2) The suspension of registration or removal from the register may be—

(a) total;

(b) limited to medicinal products of one or more descriptions; or

(c) limited to medicinal products manufactured, assembled or stored on specified premises or a specified part of any premises.

(3) The powers conferred by this regulation may not be exercised in relation to a broker’s registration except on one or more of the following grounds—

(a) the information in the application as a result of which the broker’s registration was granted was false or incomplete in a material respect;

(b) a material change of circumstances has occurred in relation to any of the matters stated in the application;

(c) the broker has materially contravened a criterion of registration; or

(d) the broker has without reasonable excuse failed to supply information to the licensing authority with respect to medicinal products of a description to which the registration relates when required to do so under regulation 45F(6).

Procedure where licensing authority proposes to suspend or vary a broker’s registration or remove a broker from the register U.K.

45H.— (1) This regulation applies where—

(a) regulation 45I does not apply; and

(b) the licensing authority proposes to exercise the power in regulation 45G(1).

(2) The licensing authority must notify the broker in writing of—

(a) its proposal;

(b) the reasons for it; and

(c) the date (which must be no earlier than 28 days from the notice given by the licensing authority) on which it is proposed that the suspension, variation or revocation should take effect.

(3) The registered broker may before the date specified in the notice—

(a) make written representations to the licensing authority with respect to the proposal; or

(b) notify the licensing authority that the broker wishes the licensing authority to submit the proposal to review upon oral representations.

(4) If the broker makes written representations in accordance with paragraph (3)(a) the licensing authority must take those representations into account before making a decision in the matter.

(5) Schedule 5 has effect if the registered broker—

(a) notifies the licensing authority of the proposal to review upon oral representations in accordance with paragraph (3)(b); and

(b) pays the fee for a review upon oral representations in accordance with the Fees Regulations.

(6) If the licensing authority proceeds to suspend or vary a registration or remove a broker from the register in accordance with the provisions of regulation 45G it must give a notice to the broker.

(7) A notice under paragraph (6) must—

(a) give particulars of the suspension, variation or removal; and

(b) give reasons for the decision to suspend, vary or remove a broker from the register.

(8) Paragraphs (6) and (7) are without prejudice to any requirement of Schedule 5 as to notification.

Suspension of a broker registration in cases of urgency U.K.

45I.— (1) The licensing authority may immediately suspend a broker’s registration for a period not exceeding three months where it appears to the licensing authority that in the interests of safety it is appropriate to do so.

(2) This paragraph applies where—

(a) a broker’s registration has been suspended under paragraph (1); and

(b) it appears to the licensing authority that it is necessary to consider whether the broker’s registration should be—

(i) further suspended or varied, or

(ii) removed from the brokers’ register.

(3) Where paragraph (2) applies, the licensing authority must proceed as set out in regulation 45H (but this is subject to paragraph (4)).

(4) Paragraph (5) applies where, in circumstances where paragraph (2) applies, the licensing authority proceeds as set out in regulation 45H and any proceedings under that regulation have not been finally disposed of before the end of the period for which the registration was suspended under paragraph (1) or further suspended under paragraph (5).

(5) If it appears to the licensing authority to be necessary in the interests of safety to do so, the authority may further suspend the registration for a period which (in the case of each further suspension) is not to exceed three months.

(6) In the event that any challenge against a decision under regulation 45H to suspend, vary or revoke the registration is made on an application under regulation 322(4), paragraph (5) shall apply, but this is without prejudice to regulation 322(6)(a) (validity of decisions and proceedings).

Variation of a broker’s registration on the application of the broker U.K.

45J.— (1) This regulation applies if the person registered as a broker applies to the licensing authority for a variation of the registration.

(2) The application must—

(a) be in writing;

(b) specify the variation requested;

(c) be signed by or on behalf of the applicant;

(d) be accompanied by such information as may be required to enable the licensing authority to consider the application;

(e) include the appropriate fee in accordance with the Fees Regulations.

(3) The licensing authority must vary a broker’s registration or refuse to vary it within 30 days beginning with the day after the date when the licensing authority receives the application.

(4) The licensing authority may give a notice to the applicant requiring the applicant to supply further information in connection with the application within the period specified in the notice.

(5) If a notice under paragraph (4) requires the applicant to provide the licensing authority with information, the information period is not to be counted for the purposes of paragraph (3).

(6) In paragraph (5), the “information period” means the period—

(a) beginning with the day on which notice is given; and

(b) ending with the day on which the licensing authority receives the information or the applicant shows to the licensing authority’s satisfaction that the applicant is unable to provide it.

(7) Nothing in this regulation affects the powers conferred by regulations 45G and 45I.

Offences: breach of regulations and false information U.K.

45K.— (1) A person is guilty of an offence if the person—

(a) contravenes regulation 45A(1); or

(b) brokers a medicinal product otherwise than in accordance with the criteria under regulation 45E relating to that person’s brokering registration.

(2) A person is guilty of an offence if the person knowingly gives false information in—

(a) an application for a broker registration under regulation 45B(2);

(b) a notification to the licensing authority under regulation 45F(4);

(c) an application for a variation under regulation 45J(1); or

(d) response to a notice under regulation 45C(3) or 45J(5).

(3) A person is guilty of an offence if, without reasonable excuse, the person fails to comply with a notice under regulation 45F(6) or 45J(5).

Penalties U.K.

45L.— (1) A person guilty of an offence under regulation 45K(1) or (2) is liable—

(a) on summary conviction to a fine not exceeding the statutory maximum; or

(b) on conviction on indictment to a fine, to imprisonment for a term not exceeding two years, or to both.

(2) A person guilty of an offence under regulation 45K(3) is liable on summary conviction to a fine not exceeding level 3 on the standard scale.]