Regulation 28 Amendment of Schedule 5 (fees for certificates of registration)

For the table in Schedule 5, substitute—

“

Column 1

Type of application

Column 2

Fees for applications in respect of products prepared from not more than 5 homoeopathic stocks

Column 3

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. £159 £393
2 An application in respect of a product which is either— £478 £704
(a) Prepared solely from repeat stocks; or
(b) Is of a repeat formulation.
3 A mutual recognition procedure incoming application in the case of a product for sale or supply in Northern Ireland, and the subsequent associate application under the unfettered access route for a COR(GB). £501 £638
4 A decentralised procedure application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for a COR(GB). £430 £563
5 Any other application. £790 £1,034

”.

Column 1 Type of application			Column 2 Fees for applications in respect of products prepared from not more than 5 homoeopathic stocks	Column 3 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.		£159	£393
2	An application in respect of a product which is either—		£478	£704
	(a)	Prepared solely from repeat stocks; or	£478	£704
	(b)	Is of a repeat formulation.
3	A mutual recognition procedure incoming application in the case of a product for sale or supply in Northern Ireland, and the subsequent associate application under the unfettered access route for a COR(GB).		£501	£638
4	A decentralised procedure application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for a COR(GB).		£430	£563
5	Any other application.		£790	£1,034