PART 7Traditional herbal registrations
Obligations of holder of traditional herbal registration
Obligation following new herbal monographF1144.
(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.