# The Medicines (Products for Human Use) (Fees) Regulations 2016, Paragraph 35: 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.
Fee for application for traditional herbal registration
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
£5,899
(b)
in any other case
£8,848
2. Standard registration application
(a)
in respect of a medicinal product containing 3 or fewer active ingredients
£2,950
(b)
in any other case
£4,424
3. Reduced registration application category II
(a)
in respect of a medicinal product containing 3 or fewer active ingredients
£983
(b)
in any other case
£1,476
4. Reduced registration application category I
(a)
in respect of a medicinal product containing 3 or fewer active ingredients
£657
(b)
in any other case
£983
5. Change of ownership application
£592
(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) £1,311, 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) £2,622, 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 £8,748 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 £777 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 £2,622 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/2016/190/schedule/2/paragraph/35 (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-35
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.