Paragraph 96 I1

For regulation 127 (amendment of regulation 144 (obligation following new herbal monograph)) substitute—

“Substitution of regulation 144 (obligation following new herbal monograph)

127

For regulation 144 substitute—

“144

(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.”.”.