The Human Medicines Regulations 2012

Validity of traditional herbal registration U.K.

Validity of traditional herbal registration U.K.

132.—(1) Subject to the following paragraphs, a traditional herbal registration remains in force—

(a) for an initial period of five years beginning with the date on which it is granted; and

(b) if the registration is renewed under regulation 133 for an unlimited period after its renewal.

(2) The licensing authority may on the first application for renewal of a registration determine on grounds relating to pharmacovigilance, including exposure of an insufficient number of patients to the medicinal product concerned, that it should be necessary for the holder to make one further application for renewal.

(3) In that event, the registration remains in force—

(a) for a further period of five years beginning with the date on which it is first renewed; and

(b) if the registration is further renewed under regulation 133 for an unlimited period after its further renewal.

(4) If an application for the renewal or further renewal of a registration is made in accordance with regulation 133 the certificate remains in force until the licensing authority notifies the applicant of its decision on the application.

(5) This regulation is subject to—

(a) regulation 134 (failure to place on the market); and

(b) regulation 135 (revocation etc of traditional herbal registration).

Application for renewal of registration U.K.

133.—(1) An application for the renewal of a traditional herbal registration must be made to the licensing authority.

(2) The applicant [F1 , where it is applying for renewal of—

(a) a THR(NI)—

(i) in accordance with Chapter 4 of Title III of the 2001 Directive, must be established in the European Union;

(ii) on any other basis, must be established in the United Kingdom;

(b) a THR(GB)—

(i) under the unfettered access route, must be established in Northern Ireland;

(ii) other than under the unfettered access route, must be established in the United Kingdom;

(c) a THR(UK), must be established in the United Kingdom.]

(3) The application must be—

(a) made in writing;

(b) signed by or on behalf of the applicant; and

(c) unless the licensing authority directs otherwise, accompanied by any fee payable in connection with the application.

(4) An application is treated as signed for the purposes of paragraph (3)(b) if it is signed with an electronic signature.

(5) The application must be made so that it is received by the licensing authority before the beginning of the period of nine months ending with the expiry of the period mentioned in paragraph (1)(a) or (3)(a) of regulation 132 (initial and further period of validity), as the case may be.

(6) The holder must provide a consolidated version of the file in respect of quality, safety and efficacy including—

(a) the evaluation of data contained in suspected adverse reaction reports and periodic safety update reports submitted in accordance with Part 11; and

(b) all variations introduced since the traditional herbal registration was granted.

(7) The licensing authority may renew a traditional herbal registration only if, having considered the application and the material accompanying it, the authority thinks that the positive therapeutic effects of the product to which the registration relates outweigh the risks of the product to the health of patients or of the public.

(8) Schedule 11 makes provision about advice and representations in relation to an application for the renewal of a traditional herbal registration.

Textual Amendments

F1 Reg. 133(2)(a)-(c) substituted for words in reg. 133(2) (31.12.2020) by S.I. 2019/775, reg. 18 (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 89); 2020 c. 1, Sch. 5 para. 1(1)

Failure to place on the market etc U.K.

134.—(1) A traditional herbal registration ceases to be in force if the product to which it relates is not placed on the market in the United Kingdom [F2 (or, in the case of a THR(GB) granted after an application under the unfettered access route, in Great Britain)] during the period of three years beginning immediately after the day on which it was granted.

(2) A traditional herbal registration for a product which has been placed on the market ceases to be in force if the product to which it relates is not sold or supplied in the United Kingdom [F3 (or, in the case of a THR(GB) granted after an application under the unfettered access route, in Great Britain)] for a period of three years.

(3) This regulation does not apply if the licensing authority grants an exemption from its operation.

(4) An exemption may be granted—

(a) in response to an application in writing by the holder of the traditional herbal registration; or

(b) by the licensing authority of its own motion.

(5) An exemption may only be granted only—

(a) in exceptional circumstances; and

(b) on public health grounds.

(6) An exemption—

(a) has effect for the period determined by the licensing authority, which may not exceed three years beginning with the day on which it is granted; and

(b) may be renewed or further renewed.

Textual Amendments

F2 Words in reg. 134(1) inserted (31.12.2020) by S.I. 2019/775, reg. 118A(2) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 90)

F3 Words in reg. 134(2) inserted (31.12.2020) by S.I. 2019/775, reg. 118A(3) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 90)