# The Medicines (Products for Human Use-Fees) Regulations 2008, Paragraph 11: Traditional herbal registrations


(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
£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
(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) £1,108, 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;
(b) £2,216, 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 £7,394 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 £657 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 £2,216 is payable in addition to the amount payable under sub-paragraph (1) in respect of that application.

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Source: https://www.legislation.gov.uk/uksi/2008/552/schedule/1/paragraph/11 (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-1/paragraph-11
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.