Regulation 96 Provision of false or misleading information

United Kingdom

(1)

The holder of a marketing authorisation F1or parallel import licence is guilty of an offence if the holder provides any information to which paragraph (2) applies that is relevant to the evaluation of the safety, quality or efficacy of a medicinal product but that is false or misleading in a material particular to—

(a)

the licensing authority;

(b)

the EMA; or

(c)

the competent authorities of other EEA States.

(2)

This paragraph applies to information about the product that is supplied pursuant to the obligations in—

(a)

these Regulations; or

(b)

Regulation (EC) No 726/2004.

(3)

This regulation is without prejudice to the operation of regulation 95.

Annotations

Textual amendments

F1: Words in reg. 96(1) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 96(1) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(o)