Failure to notify results of third country clinical trialsU.K.
91.—(1) This regulation applies to a person (“P”) if—
(a)a decision by the EMA in respect of a paediatric investigation plan is addressed to P;
(b)the plan refers to clinical trials carried out in third countries (“third country clinical trials”); and
(c)P is established in the United Kingdom.
(2) P is guilty of an offence if P does not enter into the database referred to in Article 11 of the Clinical Trials Directive the details set out in that Article in relation to the third country clinical trials in accordance with Article 41(1) of the Paediatric Regulation within whichever is the later of—
(a)the period of one month beginning after the day on which the decision was received; or
(b)the period of one month beginning after the day on which the necessary permission to conduct the clinical trial was received from the competent authorities in the country where the clinical trial is to take place.
(3) P is guilty of an offence if P does not submit the results of those clinical trials to the EMA in accordance with Article 41(2) of the Paediatric Regulation within the period of—
(a)six months, if P is the holder of a marketing authorisation for the medicinal product concerned; or otherwise
(b)twelve months,
beginning with the day on which the last of those trials ended.
(4) Paragraph (3) does not apply, and regulation 93(3) shall apply, in the case of a clinical trial that forms part of a paediatric study to which regulation 93 applies.