The Human Medicines Regulations 2012

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

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

(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 certificate 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 certificate of registration;

(c) data on the use of the product where such use is outside the terms of the certificate of 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 certificate of registration to provide the authority with information that—

(a) is specified by the licensing authority; and

(b) demonstrates that the risks of the product to the health of patients or of the public do not outweigh any beneficial effects of the product to which the certificate relates.

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

(a) in a country which is not an EEA State; or

(b) outside the terms of the certificate of registration.

(6) If the information supplied under paragraph (1), (2) or (4) entails the variation of the certificate of 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 certificate of registration to provide the authority with proof of the control methods employed by the manufacturer of the product to which the certificate relates.

(8) The licensing authority may notify the holder of a certificate of registration that it requires the holder to provide to the licensing authority information of any description specified in the notice, within the period specified in the notice, subject to paragraph (9).

(9) A notice under paragraph (8) must not be served unless it appears to the licensing authority, or it is represented to the licensing authority by the Commission or by an expert committee appointed by the licensing authority—

(a) that circumstances exist by reason of which it is necessary to consider whether the certificate of registration should be varied, suspended or revoked; and

(b) that the information required by the notice is needed to consider that question.

(10) The holder of a certificate of registration must provide the licensing authority with information that it requires under paragraphs (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.