The Human Medicines Regulations 2012

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 [F1 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

F1 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)