SCHEDULE 1CAPITAL FEES FOR APPLICATIONS FOR, AND VARIATIONS TO, MARKETING AUTHORIZATIONS, LICENCES, AUTHORISATIONS, REGISTRATIONS AND CERTIFICATES
PART 2Capital Fees for Applications for Authorizations, Licences, Registrations and Certificates
Traditional herbal registrations33
1
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 | £5,237 | ||
(b) | in any other case | £7,857 | ||
2. Standard registration application | ||||
(a) | in respect of a medicinal product containing 3 or fewer active ingredients | £2,619 | ||
(b) | in any other case | £3,928 | ||
3. Reduced registration application category II | ||||
(a) | in respect of a medicinal product containing 3 or fewer active ingredients | £873 | ||
(b) | in any other case | £1,310 | ||
4. Reduced registration application category I | ||||
(a) | in respect of a medicinal product containing 3 or fewer active ingredients | £583 | ||
(b) | in any other case | £873 | ||
5. Change of ownership application | £478 | |||
2
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.
3
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—
a
£1,164, 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; or
b
£2,328, in any other case,
is payable in addition to the amount payable under sub-paragraph (1) in respect of that application.
4
Where an application relates to a medicinal product which contains one or more new excipients, an amount of £7,767 is payable in addition to the amount payable under sub-paragraph (1) in respect of that application.
5
Where an application relates to a medicinal product which contains one or more TSE risk excipients from a new source, an amount of £690 is payable in addition to the amount payable under sub-paragraph (1) in respect of that application.
6
Where an application relates to a medicinal product which is a sterile medicinal product, an amount of £2,328 is payable in addition to the amount payable under sub-paragraph (1) in respect of that application.