127.—(1) The licensing authority may, subject to regulation 130, grant an application for a traditional herbal registration for a traditional herbal medicinal product in response to an application made in accordance with this Part.
[F1(1A) The licensing authority may accept an application meeting reduced or alternative requirements specified in this Part (“under the unfettered access route”) and grant a THR(GB) only where—
(a)there is already in place, or will be at the time the THR(GB) is granted, a traditional herbal registration in respect of the product authorising sale or supply in Northern Ireland,
(b)the applicant complies with the requirements in regulation 128(1A), and
(c)the traditional herbal medicinal product satisfies the definition of qualifying Northern Ireland goods.
(1B) A traditional herbal registration must state whether it is in force in—
(a)the whole United Kingdom;
(b)Great Britain only; or
(c)Northern Ireland only,
and in these Regulations the meaning of a reference to that traditional herbal registration being “in force” is limited to that territory.]
(2) A registration granted under paragraph (1) shall contain terms approved by the licensing authority.
(3) The applicant [F2, where it is applying for—
(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.]
(4) 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.
[F3(4A) The application must include a statement indicating whether the traditional herbal registration sought is for sale or supply of the product in—
(a)the whole United Kingdom;
(b)Great Britain only; or
(c)Northern Ireland only.]
(5) An application is treated as signed for the purposes of paragraph (4)(b) if it is signed with an electronic signature.
(6) The application and any accompanying material must be in English.
(7) The application must include a statement indicating whether the product to which the application relates should be available—
(a)only from a pharmacy; or
(b)on general sale.
(8) The application must include a statement indicating—
(a)whether any terms of the registration are proposed relating to the method of sale or supply of the product (including, in particular, any proposed restrictions affecting the circumstances of the use or promotion of the product); and
(b)if so, what terms are proposed.
Textual Amendments
F1Reg. 127(1A)(1B) inserted (31.12.2020) by S.I. 2019/775, reg. 113(2) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 84)
F2Reg. 127(3)(a)-(c) substituted for words in reg. 127(3) (31.12.2020) by S.I. 2019/775, reg. 113(3) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 84)
F3Reg. 127(4A) inserted (31.12.2020) by S.I. 2019/775, reg. 113(4) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 84)
128.—[F4(1) The applicant for the grant of a traditional herbal registration other than a THR(GB) under the unfettered access route must provide the material specified in Schedule 12 in relation to the product.
(1A) The applicant for the grant of a THR(GB) under the unfettered access route must provide—
(a)the application form submitted in connection with the granting of the THR(NI) which authorises the sale or supply of the product in Northern Ireland;
(b)a copy of all material submitted in support of the application for the THR(NI) which authorises the sale or supply of the product in Northern Ireland; and
(c)a copy of the THR(NI) which authorises the sale or supply of the medicinal product in Northern Ireland,
together with any material specified in Schedule 12 which is not included in the material specified in sub-paragraphs (a) to (c) in relation to the product.]
(2) The applicant must also, if requested by the licensing authority to do so, provide the licensing authority with material or information that the licensing authority reasonably considers necessary for considering the application.
(3) If the application relates to a product that is contained in the list referred to in Article 16f(1) of the 2001 Directive [F5where the application is for a THR(NI) or THR(UK), or the list established under regulation 126A where the application is for a THR(GB)]—
(a)the applicant does not need to provide the material referred to in paragraphs 16 to 20 of Part 1 of Schedule 12; and
(b)paragraph (2) of this regulation does not apply.
(4) Material that is submitted under this regulation must be submitted in accordance with Annex I to the 2001 Directive, so far as applicable to traditional herbal medicinal products.
Textual Amendments
F4Reg. 128(1)(1A) substituted for reg. 128(1) (31.12.2020) by S.I. 2019/775, reg. 114(2) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 85)
F5Words in reg. 128(3) inserted (31.12.2020) by S.I. 2019/775, reg. 114(3) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 85)
129.—(1) The applicant for a traditional herbal registration must update information supplied in connection with the application to include any further information that is relevant to the evaluation of the safety, quality or efficacy of the product concerned.
(2) Updated information within paragraph (1) must be provided as soon as is reasonably practicable after the applicant becomes aware of it.