# The Human Medicines Regulations 2012, Regulation 144: Obligation following new herbal monograph


(1) Paragraph (2) applies where a new herbal monograph of the kind referred to—
(a) in the case of a THR (NI) or THR (UK), in Article 16h(3) of the 2001 Directive, or
(b) in the case of a THR (GB), in regulation 143A,
is established.
(2) Where this paragraph applies, the holder of the THR(GB), THR(NI) or THR(UK) to which the monograph relates must as soon as is reasonably practicable—
(a) consider whether to modify the registration dossier; and
(b) notify any modification to the licensing authority.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/regulation/144 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/regulation-144
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.