OpenLegislation

Paragraph 29 Authorisation for a national homoeopathic product

Original text. Later amendments are not shown.

(1)

In this paragraph—

  • “formulation” does not include the formulation of a homoeopathic stock;

  • “identical” means—

    1. (a)

      in relation to the formulation of the product, identical as regards the requirements in respect of composition, preparation and testing; and

    2. (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 1Column 2Column 3
Description of applicationFee for applications in respect of products prepared from not more than 5 homoeopathic stocksFee 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.