The Human Medicines Regulations 2012

Post-authorisation safety studies: general provisions

198.—(1) A relevant post-authorisation safety study—

(a) may not be conducted where the act of conducting the study promotes the use of a medicinal product; and

(b) may not provide for payments to health care professionals for participating in the study except in compensation for time and expenses incurred.

(2) The licensing authority may require the holder for the product which is the subject of a relevant post-authorisation safety study to submit the protocol and progress reports for the study to the competent authorities of the EEA States in which the study is conducted.

(3) The holder for the product which is the subject of a relevant post-authorisation safety study must—

(a) comply with a requirement imposed by the licensing authority under paragraph (2) (if any);

(b) while the study is being conducted—

(i) monitor the data generated, and

(ii) consider its implications for the risk-benefit balance of the product which is the subject of the study;

(c) communicate to the relevant competent authorities any new information that arises at any point during the study which might influence the evaluation of the risk-benefit balance for that product as soon as is reasonably practicable after it becomes known to the holder; and

(d) send the final report on the study to the competent authorities of the EEA States in which the study was conducted before the end of the period of 12 months beginning on the day after the day on which data collection for the study ended.

(4) This regulation is subject to regulation 212 (transitional arrangements).