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.