Paragraph 29 Authorisation for a national homoeopathic product

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.

This paragraph does not apply to an application which is a mutual recognition procedure incoming application or a decentralised procedure application.

In connection with an application for a marketing authorisation 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.

In connection with any other application for a marketing authorisation 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.

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.

Where an application relates to a national homoeopathic product which is manufactured using a method of sterilisation—

an amount of F7£2,622 is payable in addition to the amount payable under sub-paragraph (3) or (4) in respect of that application.

Where an application relates to a national homoeopathic product which contains one or more new excipients, an amount of F8£8,746 is payable in addition to the amount payable under sub-paragraph (3) or (4) in respect of that application.

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 F9£773 is payable in addition to the amount payable under sub-paragraph (3) or (4) in respect of that application.