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PART 13U.K.Packaging and leaflets

CHAPTER 1U.K.

Enforcement and offencesU.K.

Non-compliance with requirements of this PartU.K.

270.—(1) If the holder of a [F1UK marketing authorisationF2...,] Article 126a authorisation, certificate of registration or traditional herbal registration fails to comply with a requirement imposed by this Part in relation to a medicinal product, the licensing authority may give a notice to the holder requiring compliance within three months or such other period (which may be less than three months) as may be specified in the notice.

(2) If the holder fails to comply with the notice, the licensing authority may suspend the [F3UK marketing authorisationF4...,] Article 126a authorisation, certificate of registration or traditional herbal registration until the holder complies with the requirements of this Part.

(3) A person who fails to comply with a notice under this regulation is guilty of an offence.