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1. Subject to paragraph 2, the fee for an application of a kind described in an entry in column (1) of the Table below shall be–
(a)the fee specified in the corresponding entry in column (2) of that Table in the case of a product prepared from not more than 5 homoeopathic stocks; and
(b)the fee specified in the corresponding entry of column (3) of that Table in the case of a product prepared from more than 5 homoeopathic stocks.
Column (1) | Column (2) | Column (3) |
---|---|---|
Description of application | Fees for applications in respect of products prepared from not more than 5 homoeopathic stocks | Fees for applications in respect of products prepared from more than 5 homoeopathic stocks |
An application in respect of a product which is both prepared solely from a repeat stock or stocks and is of a repeat formulation | £100 | £250 |
An application in respect of a product which is either– (a) prepared solely from a repeat stock or stocks; or (b) is of a repeat formulation | £300 | £450 |
Any other application | £500 | £650 |
2. Where an application for registration relates to a product–
(a)for which a certificate of registration has been granted in relation to a product which is equivalent to it under Part II of the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994(1); or
(b)which is registered or authorised in an EEA State under legislation which implements the provisions of Article 6 of the Homoeopathics Directive in such State,
the fee for such application shall be–
(i)£100 in the case of a product prepared from not more than 5 homoeopathic stocks, and
(ii)£250 in the case of a product prepared from more than 5 homoeopathic stocks.