PART 3F1Manufacture and distribution of medicinal products and active substances
F2CHAPTER 2Manufacturing and wholesale dealing
Pt. 3 Ch. 2 heading inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 4
Miscellaneous and offences
Offence concerning data for advanced therapy medicinal products33
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
b
transfer the data referred to in F5paragraph 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 F6paragraph 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.
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