Regulation 33 Offence concerning data for advanced therapy medicinal products

(1)

A person who is, or immediately before its revocation or suspension was, the holder of a manufacturer's licence relating to an advanced therapy medicinal product is guilty of an offence if the person fails to—

(a)

keep the data referred to in F1paragraph 8 of Schedule 6 in accordance with the requirements of F2paragraph 9 of that Schedule; or

(b)

transfer the data referred to in F3paragraph 8 to the licensing authority in the event of that person's bankruptcy or liquidation,

but this is subject to paragraphs (2) and (3).

(2)

Sub-paragraph (1)(b) does not apply if—

(a)

the person is bankrupt or in liquidation and has transferred the data to another person; or

(b)

the period for which the person was required to keep the data in accordance with the requirements of F4paragraph 9 mentioned in sub-paragraph (1)(a) has expired.

(3)

It is a defence for a person charged with an offence under paragraph (1) to prove that the person took all reasonable precautions and exercised all due diligence to avoid commission of the offence.

(4)

Where evidence is adduced that is sufficient to raise an issue with respect to the defence in paragraph (3), the court or jury must presume that the defence is satisfied unless the prosecution proves beyond reasonable doubt that it is not.

Annotations

Textual amendments

F1: Words in reg. 33(1)(a) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 25(2)(a); 2020 c. 1, Sch. 5 para. 1(1)
F2: Words in reg. 33(1)(a) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 25(2)(b); 2020 c. 1, Sch. 5 para. 1(1)
F3: Words in reg. 33(1)(b) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 25(3); 2020 c. 1, Sch. 5 para. 1(1)
F4: Words in reg. 33(2) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 25(4); 2020 c. 1, Sch. 5 para. 1(1)

Notes on Part 3

Textual amendments

F1: Pt. 3 heading and Pt. 3 Ch. 1 inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 4

Notes on Chapter 2

Textual amendments

F1: Pt. 3 Ch. 2 heading inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 4