Regulation 126 Insertion of new regulation 143A (establishment of herbal monographs)

After regulation 143 (obligation to take account of scientific or technical progress) insert—

“Establishment of herbal monographs

143A.

(1)

The licensing authority may establish herbal monographs for herbal medicinal products and traditional herbal medicinal products.

(2)

Subject to paragraph (3), the licensing authority must—

(a)

consult the appropriate committee, within the meaning of paragraph 2(4) of Schedule 11, on a proposal to establish herbal monographs under paragraph (1); and

(b)

take the advice of the appropriate committee into account in determining whether to proceed with that proposal.

(3)

Where an application for a traditional herbal registration has been referred to the appropriate committee by the licensing authority under regulation 130A, the licensing authority must consider whether to exercise its powers under paragraph (1), taking into account any relevant advice of the appropriate committee given under Part 3 of Schedule 11 in relation to that application.

(4)

The licensing authority must publish a list of any herbal monographs established under this regulation.

(5)

Until the licensing authority exercises the power under paragraph (1), the Community herbal monographs published from time to time under Article 16h(3) of the 2001 Directive continue to apply, and holders of a traditional herbal registration and the licensing authority must continue to take them into account in exercising any function or in relation to any obligation to which they are relevant under this Part.”.