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PART 5U.K.Marketing authorisations

Offences relating to advanced therapy medicinal productsU.K.

Offence concerning data for advanced therapy medicinal productsU.K.

88.—(1) A person who is, or immediately before its revocation or suspension was, the holder of an EU marketing authorisation 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 EMA in the event of that person's bankruptcy or liquidation in accordance with Article 15(5),

but this is subject to paragraph (2).

(2) 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 paragraph (1)(a) has expired.