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The Medicines (Products for Human Use) (Fees) Regulations 2012

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Regulation 42(1) and (2)

SCHEDULE 5FEES FOR CERTIFICATES OF REGISTRATION

Column (1)Column 2Column 3
Type of applicationFees for applications in respect of products prepared from not more than 5 homoeopathic stocksFees for other applications
1An application in respect of a product which is both prepared solely from repeat stocks and is of a repeat formulation.£172£425
2An application in respect of a product which is either—£517£761
(a)prepared solely from repeat stocks; or
(b)is of a repeat formulation.
3A mutual recognition procedure incoming application.£542£690
4A mutual recognition outgoing application (regulatory assistance).£310£405
5A decentralised procedure application where the UK is a concerned Member State.£465£608
6A decentralised procedure application where the UK is the reference Member State.£930£1,217
7Any other application.£854£1,118

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