The Human Medicines Regulations 2012

Procedure before hearingU.K.

3.—(1) The applicant must supply the reviewers with a written summary of the oral representations that the applicant wishes to make and any documents on which the applicant wishes to rely in support of them before the end of the period of three months beginning with the date of the notification mentioned in paragraph 1.U.K.

(2) The reviewers may, at the request of the applicant and after consulting the licensing authority, extend the period mentioned in sub-paragraph (1) up to a maximum of six months beginning with the date of that notification.

(3) The applicant may submit additional written representations or documents after the end of the periods for doing so only with the permission of the reviewers.

(4) In the case of a decision or a proposal by the licensing authority under Part 1, 2 or 3 of Schedule 11, the representations and documents referred to in paragraphs (1) and (3)—

(a)must not be based on any evidence or data that was not available to the licensing authority at the time that the decision or, as the case may be, the proposal that is the subject of the review was notified to the applicant by the licensing authority; unless

(b)the evidence or data is unfavourable in respect of the safety, quality or efficacy of the product concerned.

(5) The reviewers must notify the applicant and the licensing authority of the date of the hearing at least 28 days before that date, unless the applicant and the licensing authority agree to a shorter period of notice.

(6) The reviewers may establish at any stage of the procedures described in this Schedule a date by which all of those procedures, except for the hearing, must be completed, and notify this date to the applicant and to the licensing authority.

(7) The date established under sub-paragraph (6) must not be earlier than whichever is the earlier of—

(a)the first day after the end of the period of three months beginning with the date of the notification mentioned in paragraph 1; or

(b)the first day after the end of the period of 28 days beginning with the date on which the reviewers receive the written summary of the oral representations and supporting documents submitted in accordance with sub-paragraphs (1) and (3) of this paragraph,

and in any case not earlier than the first day after the period of seven days beginning on the day after the notification under sub-paragraph (6).

(8) A date established under sub-paragraph (6) may be varied or withdrawn on the application of the applicant or of the licensing authority.

(9) In the case of a decision or a proposal by the licensing authority under Part 1, 2 or 3 of Schedule 11, the reviewers must not take into account any documents or other evidence, or any representations based on such documents or evidence, in the conduct of the hearing if it thinks that the data or evidence on which the documents or representations are based, or the evidence that is presented, were not available to the licensing authority at the time when the decision or, as the case may be, the proposal that is the subject of the review was notified to the applicant by the licensing authority, unless the evidence or data is unfavourable in respect of the safety, quality or efficacy of the product concerned.

(10) The reviewers may give such other directions as they think fit for the conduct of the hearing, including—

(a)the postponing or adjournment of the hearing for such period as it may decide; and

(b)establishing a list of documents that will be taken into account in the conduct of the hearing.

(11) If the applicant fails to comply with a time limit under sub-paragraph (1), (2) or (6)—

(a)the applicant may not appear before the reviewers; and

(b)the licensing authority must decide whether—

(i)to proceed with its proposal to revoke, vary or suspend the licence,

(ii)to confirm or alter its decision,

F1(iii). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(iv)to grant or renew the UK marketing authorisation, [F2parallel import licence,] certificate of registration or traditional herbal registration or to do so otherwise than in accordance with the application, F3...

(v)to revoke, vary or suspend the authorisation, [F4licence,] certificate or registration,

[F5(vi)to proceed to suspend, vary or remove the person’s broker registration,

(vii)ro proceed to suspend, vary or remove the person’s active substance registration, or

(viii)to proceed to suspend, vary or remove the person’s entry on the list,]

as the case may be.

(12) The licensing authority must notify the applicant of its decision.

Textual Amendments

F3Word in Sch. 5 para. 3(11)(b)(iv) omitted (20.8.2013) by virtue of The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 32(b)(i)

F5Sch. 5 para. 3(11)(b)(vi)-(viii) inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 32(b)(ii)