PART 14Administration

Payment of fees in respect of a traditional herbal registration52

1

The fee payable under regulation 12 shall be refunded or, if it has not been paid, shall be waived where an application is made for the grant of a traditional herbal registration—

a

in accordance with regulation 127 (application for the grant of a traditional herbal registration) of the Human Medicines Regulations;

b

on the grounds specified in paragraph (2); and

c

in respect of a medicinal product which falls within the description in paragraph (3).

2

For the purposes of paragraph (1), the specified grounds are—

a

that the marketing authorisation in respect of the medicinal product in question; or

b

in the case of a corresponding product the marketing authorisation relating to product Y (as defined in paragraph (4)),

is to be revoked.

3

A medicinal product falls within this paragraph if—

a

a marketing authorisation held by the applicant was granted under Part 5 of the Human Medicines Regulations in respect of that medicinal product; or

b

that medicinal product is a corresponding product.

4

For the purposes of paragraph (3), a corresponding product is a product which is characterised by having—

a

the same active ingredients, irrespective of the excipients used or reduction in the number or quantity of active ingredients;

b

the same or similar intended purpose, equivalent strength and posology; and

c

the same or similar route of administration,

as a medicinal product (“product Y”) in respect of which a marketing authorisation held by the applicant was granted under Part 5 of the Human Medicines Regulations.

5

Where the licensing authority determines that the marketing authorisations in respect of the medicinal product in question or the marketing authorisation in respect of product Y should not be revoked, the fee payable under regulation 12 which has been refunded or waived shall become payable within a period of 14 days commencing on the date of the written notice issued by the licensing authority requiring payment of those fees.