The Human Medicines Regulations 2012

Revocation by licensing authority: further provisionsU.K.

This section has no associated Explanatory Memorandum

136.—(1) The licensing authority must revoke a traditional herbal registration if—

(a)the application for the registration was submitted in accordance with regulation 128(3) on the basis that the herbal medicinal product to which it relates was contained in

[F1(i)the list referred to in Article 16f(1) of the 2001 Directive, in the case of a THR(NI) or THR(UK);

(ii)the list established under regulation 126A where the application is for a THR(GB); and]

(b)the product ceases to be contained in that list.

(2) Paragraph (1) does not apply if within the period of three months beginning immediately after the day on which product ceases to be contained on the list the holder—

(a)submits to the licensing authority the material specified in Schedule 12 (including that referred to in paragraphs 16 to 20 of Part 1 of that Schedule) in relation to the product; and

(b)provides the licensing authority with any material or information that the licensing authority reasonably considers necessary for considering the application and requests the holder to provide.

F2(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F1Reg. 136(1)(a)(i)(ii) substituted for words in reg. 136(1)(a) (31.12.2020) by S.I. 2019/775, reg. 120(2) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 92); 2020 c. 1, Sch. 5 para. 1(1)