29.—(1) In this paragraph—
“formulation” does not include the formulation of a homoeopathic stock;
“identical” means—
in relation to the formulation of the product, identical as regards the requirements in respect of composition, preparation and testing; and
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.
| 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.