Medicines (Homoeopathic Medicinal Products for Human Use) Amendment Regulations 2005

Amendment of Schedule 2 to the Homoeopathic Regulations

17.—(1) Schedule 2 to the Homoeopathic Regulations (fees for applications for the grant of certificates of registration) (1) is amended as follows.

(2) In paragraph 3—

(a) after the definition of “application” insert the following definition—

““decentralised procedure application” means an application relating to a homoeopathic medicinal product in respect of which at the time of the application—

(a)

an EC registration has not been granted in any EEA State; and

(b)

an application for an EC registration has been made in more than one EEA State pursuant to Article 28(1) and (3) of the 2001 Directive;”;

(b) after the definition of “identical” insert the following definition—

““mutual recognition procedure incoming application” means an application relating to a homoeopathic medicinal product in respect of which—

(a)

an EC registration has already been granted in another EEA State; and

(b)

recognition of that certificate is sought from the licensing authority by way of the grant of a certificate of registration in the United Kingdom, pursuant to the procedure in Articles 28 and 29(1) to (3) of the 2001 Directive;”; and

(c) for the Table substitute the following Table—

“Table

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 other applications
1   An application in respect of a product which is both prepared solely from repeat stocks and is of a repeat formulation	£134	£330
2   An application in respect of a product which is either— (a) prepared solely from repeat stocks; or (b) is of a repeat formulation	£402	£592
3   A mutual recognition procedure incoming application	£465	£608
4   A decentralised procedure application where the United Kingdom is a concerned Member State	£465	£608
5   A decentralised procedure application where the United Kingdom is the reference Member State	£930	£1,217
6   Any other application	£664	£869”

(1)

Schedule 2 was substituted by regulation 3 of S.I. 1996/482.