The Medicines for Human Use (Clinical Trials) Regulations 2004

Regulations 40(5) and 44(6)

SCHEDULE 8 U.K. PROCEDURAL PROVISIONS RELATING TO PROPOSALS TO GRANT, REFUSE TO GRANT, VARY, SUSPEND OR REVOKE MANUFACTURING AUTHORISATIONS

1.  In this Schedule— U.K.

“authorisation” means a manufacturing authorisation; and

“time allowed” means the period of 28 days or such extended period as the licensing authority may in any particular case allow.

2.  Subject to paragraph 6, if the licensing authority propose— U.K.

(a) not to grant an authorisation;

(b) to grant an authorisation other than in accordance with the application; or

(c) to revoke, vary or suspend an authorisation,

the licensing authority shall notify the applicant or holder accordingly.

3.  Any notification given under paragraph 2 shall include a statement of the proposals of the licensing authority and of the reasons for them. U.K.

[F1 4.— (1) Subject to sub-paragraph (2), the applicant or holder to whom notice is given under paragraph 2 may, within the time allowed after the notification was given— U.K.

(a) notify the licensing authority that he wishes to appear before and be heard by a person appointed by the licensing authority with respect to the decision; or

(b) make representations in writing to the licensing authority with respect to the decision referred to in the notice.

(2) If the applicant or holder to whom notice is given under paragraph 2 makes written representations in accordance with sub-paragraph (1)(b), the licensing authority shall take those representations into account before deciding whether to—

(a) grant the authorisation,

(b) revoke, vary or suspend the authorisation, or

(c) confirm or alter their decision,

as the case may be.]

Textual Amendments

F1 Sch. 8 paras. 4, 5 substituted (30.10.2005) by The Medicines (Advisory Bodies) (No. 2) Regulations 2005 (S.I. 2005/2754), reg. 1(2)(b), Sch. 3 para. 6

[F1 5.— (1) If the applicant or holder gives notice under paragraph 4(1)(a) of his wish to appear before or be heard by a person appointed by the licensing authority, the authority shall— U.K.

(a) make that appointment; and

(b) arrange for the applicant or holder who gave notice to have an opportunity of appearing before the person appointed by the licensing authority.

(2) The person appointed—

(a) shall not be, or at any time have been, a member of—

(i) [F2 the Commission on Human Medicines,

(ii) an expert committee appointed by the licensing authority,

(iii) an expert advisory group within the meaning of regulation 14 of the 2012 Regulations,

(iv) the British Pharmacopoeia Commission referred to in regulation 11 of the 2012 Regulations, or any of its sub-committees,

(v) the Medicines Commission formerly established under section 2 of the Act, or any of its committees,

(vi) the Advisory Board on the Registration of Homoeopathic Products formerly established under section 4 of the Act, or any of its sub-committees, or

(vii) the Herbal Medicines Advisory Committee formerly established under section 4 of the Act, or any of its sub-committees, and]

(b) shall not be an officer or servant of a Minister of the Crown [F3 , the Scottish Ministers, the Welsh Ministers or a Northern Ireland Minister].

(3) Subject to sub-paragraph (4), the applicant or holder shall provide the person appointed with—

(a) a written summary of the oral representations he intends to make; and

(b) any documents on which he wishes to rely in support of those representations,

before the end of the period of three months beginning with the date of the notice referred to in sub-paragraph (1).

(4) If the applicant or holder so requests, the person appointed may, after consulting the licensing authority, extend the time limit referred to in sub-paragraph (3), up to a maximum period of six months beginning with the date of the notice referred to in sub-paragraph (1).

(5) If the applicant or holder fails to comply with the time limit in sub-paragraph (3) or, where he has been granted an extended time limit under sub-paragraph (4), that time limit—

(a) he may not appear before or be heard by the person appointed; and

(b) the licensing authority shall decide whether to grant the authoriSation, revoke, vary or suspend the authorisation or confirm or alter their decision, as the case may be.

(6) The applicant or holder may not submit any additional written representations or documents once the time limit has expired, except with the permission of the person appointed.

(7) At the hearing before the person appointed, both the applicant or holder and the licensing authority may make representations.

(8) If the applicant or holder so requests the hearing shall be in public.

(9) After the hearing—

(a) the person appointed shall provide a report to the licensing authority; and

(b) the licensing authority shall take this report into account and decide whether to grant the authorisation, revoke, vary or suspend the authorisation or confirm or alter their decision, as the case may be.

(10) The licensing authority shall then—

(a) notify the applicant or holder of their decision;

(b) if the applicant or holder so requests, provide him with a copy of the report of the person appointed.]

Textual Amendments

F1 Sch. 8 paras. 4, 5 substituted (30.10.2005) by The Medicines (Advisory Bodies) (No. 2) Regulations 2005 (S.I. 2005/2754), reg. 1(2)(b), Sch. 3 para. 6

F2 Sch. 8 para. 5(2)(a)(i)-(vii) substituted for Sch. 8 para. 5(2)(a)(i)-(iii) (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 63(a) (with Sch. 32)

F3 Words in Sch. 8 para. 5(2)(b) inserted (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 63(b) (with Sch. 32)

6.—(1) Paragraph 2 shall not apply to the suspension of an authorisation where it appears to the licensing authority that, in the interests of safety, it is necessary to suspend the authorisation with immediate effect for a period not exceeding 3 months. U.K.

(2) If, after the suspension has taken effect, it appears to the licensing authority that the authorisation should be further suspended or revoked, the licensing authority shall proceed in accordance with the provisions of paragraphs 2 to 5.