Paragraph 11 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—
| Column 1 | Column 2 | |||
|---|---|---|---|---|
| Kind of application | Fee payable | |||
| 1. Complex registration application | ||||
| (a) | in respect of a medicinal product containing a single active ingredient | £4,986 | ||
| (b) | in any other case | £7,480 | ||
| 2. Standard registration application | ||||
| (a) | in respect of a medicinal product containing 3 or fewer active ingredients | £2,493 | ||
| (b) | in any other case | £3,740 | ||
| 3. Reduced registration application category II | ||||
| (a) | in respect of a medicinal product containing 3 or fewer active ingredients | £831 | ||
| (b) | in any other case | £1,247 | ||
| 4. Reduced registration application category I | ||||
| (a) | in respect of a medicinal product containing 3 or fewer active ingredients | £555 | ||
| (b) | in any other case | £831 | ||
| 5. Change of ownership application | £448 | |||
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—
£1,108, if European Pharmacopoeia certificates of suitability covering all the vitamins or minerals which are a vitamin or mineral from a new source have been submitted with the application;
£2,216, in any other case,
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 £7,394 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 £657 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 £2,216 is payable in addition to the amount payable under sub-paragraph (1) in respect of that application.