The Human Medicines Regulations 2012

Offence concerning data for advanced therapy medicinal products

33.—(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 Article 15(1) of Regulation (EC) No 1394/2007 in accordance with the requirements of Article 15(4) of that Regulation; or

(b) transfer the data referred to in Article 15(1) 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 Article 15(4) 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.