Regulation 117 Insertion of regulation 130A (procedure where less than 15 years use of traditional herbal medicinal product)I1

After regulation 130 (consideration of application) insert—

“Procedure where less than 15 years use of traditional herbal medicinal product

130A

(1)

Where an application for a F1THR(GB) (other than an application under the unfettered access route) has been made and the licensing authority considers that—

(a)

the traditional herbal medicinal product does not satisfy regulation 125(5)(b) (Condition D); but

(b)

otherwise satisfies the conditions in regulation 125,

the licensing authority may refer the matter to the appropriate committee for relevant advice, and the procedure in Part 3 of Schedule 11 applies (referral to the appropriate committee for traditional herbal registrations).

(2)

In this regulation—

• “appropriate committee” has the same meaning as in paragraph 2(4) of Schedule 11;

• “relevant advice” means advice as to whether—

  1. (a)

     the conditions in regulation 125, other than condition D, are met in relation to the application; and

  2. (b)

     the licensing authority should exercise its powers under regulation 143A to establish a herbal monograph.”.