PART 5Marketing authorisations

Offences relating to the Paediatric Regulation

Failure to notify results of paediatric study93

1

This regulation applies to a person (“H”) if—

a

H is the holder of a UK marketing authorisation; and

b

H sponsors a paediatric study in respect of the product to which the authorisation relates.

2

H is guilty of an offence if H does not submit the results of the study to the licensing authority in accordance with Article 46(1) of the Paediatric Regulation within the period of six months beginning with the day on which the study ended.

3

H is guilty of an offence if H does not submit the results of any clinical trial that forms part of that study to the EMA in accordance with Article 41(2) of the Paediatric Regulation within the period of six months beginning with the day on which the trial ended.