The Human Medicines Regulations 2012

Accompanying material

128.—(1) The applicant for the grant of a traditional herbal registration must provide the material specified in Schedule 12 in relation to the product.

(2) The applicant must also, if requested by the licensing authority to do so, provide the licensing authority with material or information that the licensing authority reasonably considers necessary for considering the application.

(3) If the application relates to a product that is contained in the list referred to in Article 16f(1) of the 2001 Directive—

(a) the applicant does not need to provide the material referred to in paragraphs 16 to 20 of Part 1 of Schedule 12; and

(b) paragraph (2) of this regulation does not apply.

(4) Material that is submitted under this regulation must be submitted in accordance with Annex I to the 2001 Directive, so far as applicable to traditional herbal medicinal products.