The Human Medicines Regulations 2012

Obligation following new herbal monographU.K.

This adran has no associated Memorandwm Esboniadol

144.  Where a new herbal monograph of the kind referred to in Article 16h(3) of the 2001 Directive is established the holder of a traditional herbal registration for a product 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.