Obligation following new herbal monographU.K.
This section has no associated Explanatory Memorandum
[F1144.—(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.]
Textual Amendments
F1Reg. 144 substituted (31.12.2020) by S.I. 2019/775, reg. 127 (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 96)