# The Medicines (Products for Human Use) (Fees) Regulations 2012, Paragraph 29: Authorisation for a national homoeopathic product


(1) In this paragraph—
“formulation” does not include the formulation of a homoeopathic stock;
“identical” means—
(a) in relation to the formulation of the product, identical as regards the requirements in respect of composition, preparation and testing; and
(b) in relation to a homoeopathic stock, identical as regards the source, composition and preparation of the stock and the test which it is required to undergo;
“product” includes a series of products each of which is prepared from identical homoeopathic stocks.
(2) This paragraph does not apply to an application which is a mutual recognition procedure incoming application or a decentralised procedure application.
(3) In connection with an application for a marketing authorization for a national homoeopathic product prepared from not more than 5 homoeopathic stocks, the fee payable under regulation 12(1)(a) is the amount set out in column 2 in the table below opposite the description in column 1 appropriate to that application.
(4) In connection with any other application for a marketing authorization for a national homoeopathic product, the fee payable under regulation 12(1)(a) shall be the amount set out in column 3 in the table below opposite the description in column 1 appropriate to that application.
Fees for homoeopathic marketing authorization applications
Column 1
Column 2
Column 3
Description of application
Fee for applications in respect of products prepared from not more than 5 homoeopathic stocks
Fee for other applications
1. An application in respect of a product which is both prepared solely from repeat stocks and is of a repeat formulation
£558
£791
2. An application in respect of a product which is either—
£874
£1,096
(a)
prepared solely from repeat stocks; or
(b)
is of a repeat formulation
3. Any other application
£1,176
£1,418
(5) Each reference in sub-paragraphs (6) to (8) to an amount payable under sub-paragraph (3) or (4) in respect of an application refers to the amount payable under that sub-paragraph in respect of an application of the kind in question.
(6) Where an application relates to a national homoeopathic product which is manufactured using a method of sterilisation—
(a) not used in the manufacture of a medicinal product in respect of which a marketing authorization (other than a product licence of right), a certificate of registration or a traditional herbal registration has previously been granted; and
(b) not referred to in the European Pharmacopoeia or any national pharmacopoeia of a Member State,
an amount of £2,328 is payable in addition to the amount payable under sub-paragraph (3) or (4) in respect of that application.
(7) Where an application relates to a national homoeopathic product which contains one or more new excipients, an amount of £7,766 is payable in addition to the amount payable under sub-paragraph (3) or (4) in respect of that application.
(8) Where an application relates to a national homoeopathic product which contains one or more TSE risk ingredients from a new source or TSE risk excipients from a new source, an amount of £686 is payable in addition to the amount payable under sub-paragraph (3) or (4) in respect of that application.

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Source: https://www.legislation.gov.uk/nisr/2012/134/schedule/2/paragraph/29 (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/schedule-2/paragraph-29
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.