Regulation 79 Failure to provide information on marketing authorisations to EMA
The holder of F1a UKMA(NI) or F2UKMA(UK)(Category 2) is guilty of an offence if the holder—
has not submitted information to the EMA as required by Article 57(2)(b) of Regulation (EC) No 726/2004 (information on all existing medicinal products for human use authorised or registered in the EU) in relation to any medicinal product that is the subject of a marketing authorisation granted before 2nd July 2012; and
fails to do so as soon as is reasonably practicable after the coming into force of these Regulations.
The holder of F3UKMA(NI) or F4UKMA(UK)(Category 2) is guilty of an offence if the holder fails to submit information to the EMA as required by Article 57(2)(c) of Regulation (EC) No 726/2004 (information on any new or varied authorisations granted in the EU) in relation to any medicinal product that is the subject of a marketing authorisation granted on or after 2nd July 2012 as soon as is reasonably practicable after the grant of the authorisation.
Annotations
Textual amendments
- F1
Words in reg. 79(1) substituted (31.12.2020) by S.I. 2019/775, reg. 88(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 65)
- F2
Words in reg. 79(1) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 62
- F3
Words in reg. 79(2) substituted (31.12.2020) by S.I. 2019/775, reg. 88(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 65)
- F4
Words in reg. 79(2) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 62