The Medicines (Products for Human Use) (Fees) Regulations 2012

Payment of fees in respect of a traditional herbal registration

47.—(1) Where an application is made for the grant of a traditional herbal registration—

(a) in accordance with regulation 5 (applications for the grant or renewal of a traditional herbal registration) of the Herbal 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),

the fee payable under regulation 12 shall be refunded or, if it has not been paid, shall be waived.

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

(a) that the marketing authorization in respect of the medicinal product in question; or

(b) in the case of a corresponding product the marketing authorization 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 authorization held by the applicant was granted under the Marketing Authorisation 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 authorization held by the applicant was granted under the Marketing Authorisation Regulations.

(5) Where the licensing authority determines that the marketing authorizations in respect of the medicinal product in question or the marketing authorization 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.