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Regulation 17 Substitution of regulation 97

Original text. Later amendments are not shown.

For regulation 97 (breach of pharmacovigilance condition) substitute—

“Breach of pharmacovigilance condition

97.
(1)

The holder of a marketing authorisation or a parallel import licence is guilty of an offence if the holder fails to comply with a condition to which the marketing authorisation or parallel import licence is subject by virtue of regulation 59 (conditions of a UK marketing authorisation or parallel import licence: general).

(2)

The holder of a marketing authorisation is guilty of an offence if the holder fails to comply with a condition to which the marketing authorisation is subject by virtue of regulation 60 (conditions of a UK marketing authorisation: exceptional circumstances) or 61 (conditions of a UK marketing authorisation: new obligations post-authorisation).”