The Human Medicines Regulations 2012

Obligations of holder of traditional herbal registration U.K.

Obligation to notify placing on the market etc U.K.

142.—(1) The holder of a traditional herbal registration must notify the licensing authority of the date on which the product to which the registration relates is placed on the market in the United Kingdom taking account of the various presentations authorised.

(2) A notification under paragraph (1) must be given before the end of the period of two months beginning with the date on which the product is placed on the market.

(3) The holder of a traditional herbal registration must notify the licensing authority if the product to which the registration relates is to be withdrawn from the market in the United Kingdom (whether temporarily or permanently).

(4) A notification under paragraph (3) must be given before the beginning of the period of two months ending with the date on which the product is to be withdrawn from the market unless it is not reasonably practicable to do so.

(5) In that event, the notification must be given as far as is reasonably practicable in advance of the date on which the product is withdrawn from the market.

[F1 (5A) The holder of a traditional herbal registration must notify the licensing authority forthwith if the holder takes action to—

(a) request the cancellation of the registration;

(b) not apply for the renewal of the registration; or

(c) withdraw the product to which the registration relates from the market in a third country (whether temporarily or permanently) and the action is based on any of the grounds set out in Article 116 or 117(1) of the 2001 Directive.

(5B) A notification under paragraph (3) or (5A) must include the reasons for the action, in particular declaring if the action is based on any of the grounds set out in Article 116 or 117(1) of the 2001 Directive.

(5C) The holder of a [F2 THR(NI) or THR(UK)] must notify the EMA forthwith where the action which is the subject of a notification by the holder under paragraph (3) or (5A) is based on any of the grounds set out in Article 116 or 117(1) of the 2001 Directive.]

(6) The licensing authority may require the holder of a traditional herbal registration to provide information relating to the volume of sales in the United Kingdom of the product to which the registration relates.

(7) The holder of a traditional herbal registration must provide the licensing authority with information that it requires under paragraph (6)—

(a) where the period within which the information must be provided is specified in a written notice given to the holder by the licensing authority, before the end of that period; or

(b) otherwise, as soon as is reasonably practicable after receipt of the request.

Textual Amendments

F1 Reg. 142(5A)-(5C) inserted (11.11.2013) by The Human Medicines (Amendment) (No. 2) Regulations 2013 (S.I. 2013/2593), regs. 1(2), 6

F2 Words in reg. 142(5C) substituted (31.12.2020) by S.I. 2019/775, reg. 125 (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 94); 2020 c. 1, Sch. 5 para. 1(1)

Obligation to take account of scientific and technical progress U.K.

143.—(1) The holder of a traditional herbal registration must keep under review the methods of manufacture and control of the product to which the registration relates, taking account of scientific and technical progress.

(2) As soon as is reasonably practicable after becoming aware of the need to do so, the holder must apply to vary the traditional herbal registration to make any changes to those methods that are required to ensure they are generally accepted scientific methods.

[F3 Establishment of herbal monographs U.K.

143A.— (1) The licensing authority may establish herbal monographs for herbal medicinal products and traditional herbal medicinal products to be placed on the market in Great Britain.

(2) Subject to paragraph (3), the licensing authority must—

(a) consult the appropriate committee, within the meaning of paragraph 2(4) of Schedule 11, on a proposal to establish herbal monographs under paragraph (1); and

(b) take the advice of the appropriate committee into account in determining whether to proceed with that proposal.

(3) Where an application for a traditional herbal registration has been referred to the appropriate committee by the licensing authority under regulation 130A, the licensing authority must consider whether to exercise its powers under paragraph (1), taking into account any relevant advice of the appropriate committee given under Part 3 of Schedule 11 in relation to that application.

(4) The licensing authority must publish a list of any herbal monographs established under this regulation.

(5) Until the licensing authority exercises the power under paragraph (1), the Community herbal monographs published from time to time under Article 16h(3) of the 2001 Directive continue to apply, and holders of a traditional herbal registration and the licensing authority must continue to take them into account in exercising any function or in relation to any obligation to which they are relevant under this Part.]

Textual Amendments

F3 Reg. 143A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 126 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 95); 2020 c. 1, Sch. 5 para. 1(1)

Obligation following new herbal monograph U.K.

[F4 144.— (1) Paragraph (2) applies where a new herbal monograph of the kind referred to—

(a) in the case of a THR (NI) or THR (UK), in Article 16h(3) of the 2001 Directive, or

(b) in the case of a THR (GB), in regulation 143A,

is established.

(2) Where this paragraph applies, the holder of the THR(GB), THR(NI) or THR(UK) to which the monograph relates must as soon as is reasonably practicable—

(a) consider whether to modify the registration dossier; and

(b) notify any modification to the licensing authority.]

Textual Amendments

F4 Reg. 144 substituted (31.12.2020) by S.I. 2019/775, reg. 127 (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 96)

Obligation to provide information relating to safety etc U.K.

145.—(1) The holder of a traditional herbal registration must provide the licensing authority with any new information that might entail the variation of the registration.

(2) The holder must, in particular, provide the licensing authority with the following information—

(a) information about any prohibition or restriction imposed in relation to the product to which the registration relates by the competent authority of any country in which the product is on the market;

(b) positive and negative results of clinical trials or other studies in all indications and populations, whether or not included in the traditional herbal registration;

(c) data on the use of the product where such use is outside the terms of the traditional herbal registration; and

(d) any other information that the holder considers might influence the evaluation of the benefits and risks of the product.

(3) Information within paragraph (1) or (2) must be provided as soon as is reasonably practicable after the holder becomes aware of it.

(4) The licensing authority may require the holder of a traditional herbal registration to provide the authority with information that—

(a) is specified by the licensing authority; and

(b) demonstrates 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.

(5) The information that may be required under paragraph (4) includes information arising from use of the product—

(a) in a country [F5 other than the United Kingdom]; or

(b) outside the terms of the traditional herbal registration,

including use in clinical trials.

(6) If the information supplied under paragraph (1), (2) or (4) entails the variation of the traditional herbal registration, the holder must make an application to the licensing authority to that effect as soon as is reasonably practicable after becoming aware of the information.

(7) The licensing authority may require the holder of a traditional herbal registration to provide the authority with proof of the control methods employed by the manufacturer of the product to which the registration relates.

(8) The holder of a traditional herbal registration must provide the licensing authority with information that it requires under paragraph (4) or (7)—

(a) where the period within which the information must be provided is specified in a written notice given to the holder by the licensing authority, before the end of that period; or

(b) otherwise, as soon as is reasonably practicable after receipt of the request.

Textual Amendments

F5 Words in reg. 145(5)(a) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 128; 2020 c. 1, Sch. 5 para. 1(1)

Obligation in relation to product information U.K.

146.—(1) The holder of the traditional herbal registration for a medicinal product must ensure that the product information relating to the product is kept up to date with current scientific knowledge.

[F6 (2) In this regulation “current scientific knowledge” includes the conclusions of the assessment and recommendations made public by means of—

(a) in the case of a medicinal product for sale or supply in Northern Ireland—

(i) the European medicines web-portal established in accordance with Article 26 of Regulation (EC) No 726/2004, and

(ii) the UK web-portal established in accordance with regulation 203(1);

(b) in the case of a medicinal product for sale or supply in Great Britain only, the UK web-portal established in accordance with regulation 203(1).]

Textual Amendments

F6 Reg. 146(2) substituted (31.12.2020) by S.I. 2019/775, reg. 129 (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 97)

Record-keeping obligations U.K.

147.  The holder of a traditional herbal registration must keep any documents or information that will facilitate the withdrawal or recall from sale or supply of any product to which the registration relates.

Obligation to ensure appropriate and continued supplies U.K.

148.  The holder of a traditional herbal registration must take all reasonable steps to ensure appropriate and continued supplies of the product to which the registration relates to pharmacies and persons authorised to supply the product so that the needs of patients in the United Kingdom are met.

[F7 Urgent safety restrictions U.K.

148A.— (1) Where, in the event of a risk to public health, the holder of a traditional herbal registration takes urgent safety restrictions on its own initiative, it must inform the licensing authority immediately.

(2) If the licensing authority has not raised objections within 24 hours following receipt of that information, the urgent safety restrictions are deemed to be accepted by the licensing authority.

(3) In the event of a risk to public health, the licensing authority may impose urgent safety restrictions.

(4) Where an urgent safety restriction is taken by the holder of a traditional herbal registration, or imposed by the licensing authority, the holder must submit an application for variation of that registration in relation to that restriction within 15 days beginning with the date of the initiation of that restriction.]

Textual Amendments

F7 Reg. 148A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 130; 2020 c. 1, Sch. 5 para. 1(1)