PART 8ENFORCEMENT AND RELATED PROVISIONS
False or misleading information50
1
Any person who in the course of—
a
making an application for an ethics committee opinion;
b
making a request for authorisation to conduct a clinical trial; or
c
making an application for the grant or variation of a manufacturing authorisation,
provides to the licensing authority or an ethics committee any relevant information which is false or misleading in a material particular shall be guilty of an offence.
2
Any person who—
a
is conducting a clinical trial authorised in accordance with these Regulations;
b
is a sponsor of such a clinical trial;
c
while acting under arrangements made with a sponsor of such a clinical trial, performs the functions of that sponsor; or
d
holds a manufacturing authorisation,
and who, for the purposes of these Regulations, provides to the licensing authority or an ethics committee any relevant information which is false or misleading in a material particular shall be guilty of an offence.
3
Any person who, for the purpose of being engaged as a qualified person in accordance with regulation 43, provides to the licensing authority or to the holder of a manufacturing authorisation any information which is false or misleading in a material particular shall be guilty of an offence.
4
In this regulation, “relevant information” means any information which is relevant to an evaluation of—
a
the safety, quality or efficacy of an investigational medicinal product;
b
the safety or scientific validity of a clinical trial; or
c
whether, with regard to a clinical trial, the conditions and principles of good clinical practice are being satisfied or adhered to.