OpenLegislation

Regulation 16 Insertion of regulation 95A

Original text. Later amendments are not shown.

After regulation 95 (offences in connection with marketing authorisation application) insert—

“Offences in connection with parallel import licence application

95A.

A person is guilty of an offence if, in the course of an application for the grant, renewal or variation of a parallel import licence for a relevant medicinal product, the person—

(a)

fails to provide the licensing authority with any information that is relevant to the evaluation of the safety, quality or efficacy of the product; or

(b)

provides to the licensing authority any information that is relevant to the evaluation of the safety, quality or efficacy of the product but that is false or misleading in a material particular.”