Paragraph 35 Traditional herbal registrations

Subject to sub-paragraphs (3) to (6), the fee payable under regulation 12(1)(a) in connection with an application for a traditional herbal registration of a kind described in column 1 of the following table is the fee specified in the corresponding entry in column 2 of that table.

Each reference in sub-paragraphs (3) to (6) to an amount payable under sub-paragraph (1) in respect of an application refers to the amount payable under that sub-paragraph in respect of an application of the kind in question.

Where an application relates to a medicinal product which contains one or more vitamins or minerals which are vitamins or minerals from a new source, a fee of—

is payable in addition to the amount payable under sub-paragraph (1) in respect of that application.

Where an application relates to a medicinal product which contains one or more new excipients, an amount of F12£8,748 is payable in addition to the amount payable under sub-paragraph (1) in respect of that application.

Where an application relates to a medicinal product which contains one or more TSE risk excipients from a new source, an amount of F13£777 is payable in addition to the amount payable under sub-paragraph (1) in respect of that application.

Where an application relates to a medicinal product which is a sterile medicinal product, an amount of F14£2,622 is payable in addition to the amount payable under sub-paragraph (1) in respect of that application.