The Human Medicines Regulations 2012

PART 1 U.K. General procedures

Application of this Part U.K.

1.—(1) This Part of this Schedule applies to— U.K.

(a) an application for the grant of a UK marketing authorisation, certificate of registration or traditional herbal registration;

(b) an application to renew a UK marketing authorisation, certificate of registration or traditional herbal registration; F1 ...

(c) a proposal to revoke, vary or suspend a UK marketing authorisation, certificate of registration or traditional herbal registration (including variation by the variation or removal of a condition to which a UK marketing authorisation or a certificate of registration is subject) other than a proposal to vary the authorisation, certificate or registration on the application of or by agreement with its holder [F2 ; and

(d) a proposal to decide that the orphan criteria are not met in relation to a medicinal product which is the subject of an application for the grant of a UK marketing authorisation.]

[F3 (1A) Paragraphs 12 and 13 of this Part also apply to—

(a) an application for the grant of a parallel import licence;

(b) an application to renew a parallel import licence;

(c) a proposal to revoke, vary or suspend a parallel import licence (including variation by the variation or removal of a condition to which a parallel import licence is subject) other than a proposal to vary the licence on the application of or by agreement with its holder; and

(d) a refusal to vary a parallel import licence following an application for a variation by the holder.]

[F4 (2) In relation to an application for a UKMA(NI) or THR(NI), this Part is subject to Part 4 of this Schedule.]

Textual Amendments

F1 Word in Sch. 11 para. 1(1)(b) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 63(2)(a)(i); 2020 c. 1, Sch. 5 para. 1(1)

F2 Sch. 11 para. 1(1)(d) and word inserted (31.12.2020) by S.I. 2019/775, reg. 63(2)(a)(ii) (as substituted by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/1385), reg. 1, Sch. 1 para. 7(2); 2020 c. 1, Sch. 5 para. 1(1))

F3 Sch. 11 para. 1(1A) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 63(2)(b); 2020 c. 1, Sch. 5 para. 1(1)

F4 Sch. 11 para. 1(2) substituted (31.12.2020) by S.I. 2019/775, reg. 63(2)(c) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 46(a))

Requirement to consult the appropriate committee U.K.

2.—(1) The licensing authority must consult the appropriate committee if the authority proposes on grounds relating to safety, quality or efficacy— U.K.

(a) to refuse to grant or renew a UK marketing authorisation or traditional herbal registration in response to the application; or

(b) to revoke, vary or suspend a UK marketing authorisation or traditional herbal registration.

(2) The licensing authority must consult the appropriate committee if the authority proposes on grounds relating to safety or quality—

(a) to refuse to grant or renew a certificate of registration in response to the application; or

(b) to revoke, vary or suspend a certificate of registration.

[F5 (2A) The licensing authority must consult the appropriate committee if the authority proposes to decide that the orphan criteria are not met in relation to a medicinal product which is the subject of an application for the grant of a UK marketing authorisation.]

(3) This paragraph is subject to paragraphs 3 and 4 (exceptions to requirement to consult).

(4) In this Schedule “the appropriate committee” in relation to any function means whichever of the bodies listed in paragraph (5) the licensing authority considers to be the appropriate body to perform that function.

(5) Those bodies are—

(a) the Commission; and

(b) any expert committee appointed by the licensing authority.

Textual Amendments

F5 Sch. 11 para. 2(2A) inserted (31.12.2020) by S.I. 2019/775, reg. 63(2A) (as inserted by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/1385), reg. 1, Sch. 1 para. 7(3); 2020 c. 1, Sch. 5 para. 1(1))

Exceptions to requirement to consult U.K.

3.—(1) Paragraph 2 does not apply to a proposal to refuse to grant or renew a UK marketing authorisation, certificate of registration or traditional herbal registration [F6 , or to a proposal to decide that the orphan criteria are not met in relation to a medicinal product which is the subject of an application for the grant of a UK marketing authorisation,] if— U.K.

(a) the licensing authority has asked the applicant to supply information that the licensing authority thinks is relevant to enable the application to be determined [F7 or the decision to be made]; and

(b) the information has not been supplied to the authority within the relevant period.

(2) The relevant period is—

(a) where the licensing authority has completed its initial full assessment of the application, the period of six months beginning with the date when the authority asked the applicant to supply the information mentioned in sub-paragraph (1); or

(b) where the licensing authority has completed its assessment of any supplemental information, the period of three months beginning with the date when the authority asked the applicant to supply the information mentioned in sub-paragraph (1).

(3) The licensing authority may extend the relevant period if—

(a) the applicant asks it to do so;

(b) the applicant provides the grounds for that request; and

(c) the licensing authority thinks that the grounds are exceptional.

Textual Amendments

F6 Words in Sch. 11 para. 3(1) inserted (31.12.2020) by S.I. 2019/775, reg. 63(2B)(a) (as inserted by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/1385), reg. 1, Sch. 1 para. 7(3); 2020 c. 1, Sch. 5 para. 1(1))

F7 Words in Sch. 11 para. 3(1)(a) inserted (31.12.2020) by S.I. 2019/775, reg. 63(2B)(b) (as inserted by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/1385), reg. 1, Sch. 1 para. 7(3); 2020 c. 1, Sch. 5 para. 1(1))

4.—(1) Paragraph 2 does not apply to a proposal to suspend a UK marketing authorisation, certificate of registration or traditional herbal registration if the licensing authority thinks that, in the interests of safety, it is necessary to suspend the authorisation, certificate or registration with immediate effect for not more than three months. U.K.

(2) In that event the licensing authority must report the suspension to the appropriate committee forthwith.

(3) Sub-paragraph (4) applies if, following a suspension to which this paragraph applies—

(a) the licensing authority thinks that the authorisation, certificate or registration should be further suspended, or varied or revoked; or

(b) the appropriate committee advises that the authorisation, certificate or registration should be further suspended, or varied or revoked.

(4) The provisions of this Part of this Schedule (including this paragraph) apply accordingly to the suspension, variation or revocation.

Provisional opinion against authorisation U.K.

5.—(1) If the appropriate committee is consulted under paragraph 2(1) it may give a provisional opinion that on grounds relating to safety, quality or efficacy— U.K.

(a) it may be unable to advise the licensing authority to grant or renew the UK marketing authorisation or traditional herbal registration;

(b) it may be unable to advise the licensing authority to grant the authorisation or registration unless—

(i) it contains terms other than those in the application, or

(ii) it is granted subject to conditions; or

(c) it may have to advise the licensing authority to revoke, vary or suspend the authorisation or registration.

(2) If the Commission is consulted under paragraph 2(2), it may give a provisional opinion that, on grounds relating to safety or quality—

(a) it may be unable to advise the licensing authority to grant or renew the certificate of registration;

(b) it may be unable to advise the licensing authority to grant the certificate unless—

(i) it contains terms other than those in the application, or

(ii) it is granted subject to conditions; or

(c) it may have to advise the licensing authority to revoke, vary or suspend the certificate.

[F8 (2A) If the appropriate committee is consulted under paragraph 2(2A), it may give a provisional opinion that it may be unable to advise the licensing authority to decide that the orphan criteria are met in relation to a medicinal product which is the subject of an application for the grant of a UK marketing authorisation.]

(3) The appropriate committee must notify the applicant for the grant or renewal [F9 , the applicant intending to demonstrate that the orphan criteria are met in relation to a medicinal product,] or (as the case may be) the holder of the authorisation, certificate or registration in writing of its provisional opinion.

Textual Amendments

F8 Sch. 11 para. 5(2A) inserted (31.12.2020) by S.I. 2019/775, reg. 63(2C)(a) (as inserted by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/1385), reg. 1, Sch. 1 para. 7(3); 2020 c. 1, Sch. 5 para. 1(1))

F9 Words in Sch. 11 para. 5(3) inserted (31.12.2020) by S.I. 2019/775, reg. 63(2C)(b) (as inserted by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/1385), reg. 1, Sch. 1 para. 7(3); 2020 c. 1, Sch. 5 para. 1(1))

Opportunity to make representations U.K.

6.—(1) An applicant or holder notified under paragraph 5 may, by notice in writing to the appropriate committee, request the opportunity to make written or oral representations to the appropriate committee. U.K.

(2) The applicant or holder must make the request within the period of 28 days beginning with the day on which the notification is given or such longer period as the licensing authority may allow.

Written representations U.K.

7.—(1) If the applicant or holder requests the opportunity to make written representations, the applicant or holder must provide the appropriate committee with those representations and any documents on which the applicant or holder wishes to rely in support of them— U.K.

(a) before the end of the period of six months beginning with the date of the request; or

(b) before the end of such shorter period as the appropriate committee may specify in the notification under paragraph 5.

(2) The appropriate committee may at the request of the applicant or holder extend the period mentioned in sub-paragraph (1) up to a maximum of twelve months beginning with the date of the request under paragraph 6.

(3) The applicant or holder may submit additional representations or documents after the end of the period for doing so only with the permission of the appropriate committee.

(4) The appropriate committee must—

(a) take the representations made under this paragraph into account; and

(b) report its findings and advice to the licensing authority together with the reasons for that advice.

Oral representations U.K.

8.—(1) If the applicant or holder requests the opportunity to make oral representations, the applicant or holder must provide the appropriate committee with a written summary of those representations and any documents on which the applicant or holder wishes to rely in support of them— U.K.

(a) before the end of the period of six months beginning with the date of the request; or

(b) before the end of such shorter period as the appropriate committee may specify in the notification under paragraph 5.

(2) The appropriate committee may at the request of the applicant or holder extend the period mentioned in sub-paragraph (1) up to a maximum of twelve months beginning with the date of the request under paragraph 6.

(3) The applicant or holder may submit additional written representations or documents after the end of the period for doing so only with the permission of the appropriate committee.

(4) After receiving the summary and any other documents provided under this paragraph, the appropriate committee must arrange for the applicant or holder to make oral representations at a hearing before the committee.

(5) The appropriate committee must—

(a) take the representations made under this paragraph into account; and

(b) report its findings and advice to the licensing authority together with the reasons for that advice.

Other decisions of the appropriate committee U.K.

9.—(1) This paragraph applies if the applicant or holder— U.K.

(a) does not request the opportunity to make written or oral representations to the appropriate committee within the period mentioned in paragraph 6;

(b) requests the opportunity to make written representations, but fails to make those written representations within the period for doing so; or

(c) requests the opportunity to make oral representations, but—

(i) fails to provide a summary of those representations or the documents in support of them within the period for doing so, or

(ii) fails to make oral representations at a hearing before the appropriate committee.

(2) The appropriate committee must notify the licensing authority of that fact.

Decision of licensing authority U.K.

10.—(1) After receiving the appropriate committee's report under paragraph 7 or 8 or notification under paragraph 9 the licensing authority must— U.K.

(a) decide whether to grant or renew the UK marketing authorisation, certificate of registration or traditional herbal registration;

(b) decide whether to grant or renew the authorisation, certificate or registration in accordance with the application; F10 ...

(c) decide whether to proceed with its proposal to revoke, vary or suspend the authorisation, certificate or registration [F11 ; or

(d) decide whether to proceed with its proposal to decide that the orphan criteria are not met in relation to a medicinal product which is the subject of an application for the grant of a UK marketing authorisation,]

as the case may be.

(2) If the appropriate committee has given a report under paragraph 7 or 8, the licensing authority must take the report into account in making its decision.

(3) The licensing authority must notify the applicant or holder of—

(a) its decision; and

(b) any advice given to it by the appropriate committee and the reasons for that advice.

Textual Amendments

F10 Word in Sch. 11 para. 10(1)(b) omitted (31.12.2020) by virtue of S.I. 2019/775, reg. 63(2D)(a) (as inserted by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/1385), reg. 1, Sch. 1 para. 7(3); 2020 c. 1, Sch. 5 para. 1(1))

F11 Sch. 11 para. 10(1)(d) and word inserted (31.12.2020) by S.I. 2019/775, reg. 63(2D)(b) (as inserted by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/1385), reg. 1, Sch. 1 para. 7(3); 2020 c. 1, Sch. 5 para. 1(1))

Right to review after paragraph 10 notification U.K.

11.—(1) A person to whom a notification is given under paragraph 10 may notify the licensing authority in writing that the person wishes the licensing authority to submit the decision to review upon oral representations. U.K.

(2) The person must give the notification within the period of 28 days beginning with the day on which the notification under paragraph 10 is given or such longer period as the licensing authority may allow.

(3) The review must be conducted in accordance with Schedule 5.

(4) This paragraph does not apply if—

(a) the person has not made any representations in accordance with paragraph 7 or 8; and

(b) the decision of the licensing authority is in accordance with the advice of the appropriate committee.

Licensing authority decisions in other cases U.K.

12.—(1) This paragraph applies if the appropriate committee has not been consulted under paragraph 2(1) because the licensing authority proposes on grounds not relating to safety, quality or efficacy— U.K.

(a) to refuse to grant or renew a UK marketing authorisation [F12 , parallel import licence] or traditional herbal registration in response to the application;

(b) to grant or renew a UK marketing authorisation [F12 , parallel import licence] or traditional herbal registration otherwise than in accordance with the application; or

(c) to revoke, vary or suspend a UK marketing authorisation [F12 , parallel import licence] or traditional herbal registration.

(2) This paragraph also applies if, having been consulted under paragraph 2(1), the appropriate committee has not given a provisional opinion in the terms described in paragraph 5(1), and the licensing authority proposes—

(a) to determine the application for the UK marketing authorisation or traditional herbal registration in a way that differs from the appropriate committee's advice;

(b) to revoke, vary or suspend the authorisation or registration against such advice; or

(c) on grounds not relating to safety, quality or efficacy—

(i) to refuse to grant or renew the authorisation or registration,

(ii) to grant or renew the authorisation or registration otherwise than in accordance with the application, or

(iii) to revoke, vary or suspend the authorisation or registration.

(3) This paragraph also applies if the appropriate committee has not been consulted under paragraph 2(2) because the licensing authority proposes on grounds not relating to safety or quality—

(a) to refuse to grant or renew a certificate of registration in response to the application;

(b) to grant or renew a certificate of registration otherwise than in accordance with the application; or

(c) to revoke, vary or suspend a certificate of registration.

(4) This paragraph also applies if, having been consulted under paragraph 2(2), the appropriate committee has not given a provisional opinion in the terms described in paragraph 5(2), and the licensing authority proposes—

(a) to determine the application for the certificate of registration in a way that differs from the appropriate committee's advice;

(b) to revoke, vary or suspend the authorisation against such advice; or

(c) on grounds not relating to safety or quality—

(i) to refuse to grant or renew the certificate,

(ii) to grant or renew the certificate otherwise than in accordance with the application, or

(iii) to revoke, vary or suspend the certificate.

[F13 (4A) This paragraph also applies if, having been consulted under paragraph 2(2A), the appropriate committee has not given a provisional opinion in the terms described in paragraph 5(2A) and the licensing authority proposes to decide, against that committee's advice, that the orphan criteria are not met in relation to a medicinal product which is the subject of an application for the grant of a UK marketing authorisation.]

(5) The licensing authority must notify the applicant for the grant or renewal or (as the case may be) the holder of the authorisation [F14 , licence], certificate or registration in writing of its proposal.

(6) The notification must state—

(a) the reasons for the proposal; and

(b) any advice of the appropriate committee and any reasons it has given for that advice.

Textual Amendments

F12 Words in Sch. 11 para. 12(1) inserted (31.12.2020) by S.I. 2019/775, reg. 63(3)(a) (as substituted by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/1385), reg. 1, Sch. 1 para. 7(4); 2020 c. 1, Sch. 5 para. 1(1))

F13 Sch. 11 para. 12(4A) inserted (31.12.2020) by S.I. 2019/775, reg. 63(3)(c) (as substituted by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/1385), reg. 1, Sch. 1 para. 7(4); 2020 c. 1, Sch. 5 para. 1(1))

F14 Word in Sch. 11 para. 12(5) inserted (31.12.2020) by S.I. 2019/775, reg. 63(3)(b) (as substituted by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/1385), reg. 1, Sch. 1 para. 7(4); 2020 c. 1, Sch. 5 para. 1(1))

Right to review or representations after paragraph 12 notification U.K.

13.—(1) A person to whom a notification is given under paragraph 12 may— U.K.

(a) notify the licensing authority in writing that the person wishes the licensing authority to submit the proposal to review upon oral representations, or

(b) make representations in writing to the licensing authority with respect to the proposal.

(2) The person must give the notification or make the representations within the period of 28 days beginning with the day on which the notification is given or such longer period as the licensing authority may allow.

(3) A review in accordance with sub-paragraph (1)(a) must be conducted in accordance with Schedule 5.

(4) If the person makes written representations in accordance with sub-paragraph (1)(b) the licensing authority must take them into account before determining the matter.