# The Human Medicines (Amendment etc.) (EU Exit) (No. 2) Regulations 2021, 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
”.

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Source: https://www.legislation.gov.uk/ukdsi/2021/9780348228755/regulation/28 (the official version)
Page: https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-no-2-regulations-2021/regulation-28
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.

