The Human Medicines Regulations 2012

Grant or refusal of licence U.K.

23.—(1) Subject to the following provisions of these Regulations, on an application to the licensing authority for a licence under this Part the licensing authority may—

(a) grant a licence containing such provisions as it considers appropriate; or

(b) refuse to grant a licence if having regard to the provisions of these Regulations F1 ... it considers it necessary or appropriate to do so.

(2) The licensing authority must grant or refuse an application for a licence under this Part within the period of 90 days beginning immediately after the day on which it receives the application.

(3) Paragraph (2) applies to an application only if the requirements of Schedule 3 have been met.

(4) If a notice under regulation 30 requires the applicant to provide the licensing authority with information, the information period is not to be counted for the purposes of paragraph (2).

(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.

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

(a) the licensing authority refuses to grant an application for a licence; or

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

Textual Amendments

F1 Words in reg. 23(1)(b) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 19; 2020 c. 1, Sch. 5 para. 1(1)