Regulation 198 Post-authorisation safety studies: general provisions

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

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

the competent authorities of the EEA States in which the study is conducted F2and the licensing authority, where the product is subject to a F3UKMA(UK)(Category 2), UKMA(UK)(NI), traditional herbal registration or Article 126a authorisation for sale or supply in Northern Ireland;

the licensing authority, where the product is subject to a F5UKMA(UK)(Category 1), a UKMA(GB) or traditional herbal registration for sale or supply in Great Britain only.

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

while the study is being conducted—

communicate to

F7any 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

send the final report on the study to

F11before the end of the period of 12 months beginning on the day after the day on which data collection for the study ended.