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Paragraph 18 Decentralised procedure where the United Kingdom is the reference member State

Original text. Later amendments are not shown.

(1)

Where an application is submitted using the decentralised procedure the following fees are payable if the United Kingdom is the reference member State—

Fee for the decentralised procedure where the United Kingdom is the reference member State

Type of applicationFee(£)
Standard application10,400
Application for a new active substance29,510
Complex application18,800
Application for a pharmacologically equivalent product where the reference product is authorised in the United Kingdom9,000
Application for a pharmacologically equivalent product where reference product is not authorised in the United Kingdom10,400 plus any translation costs
Application using identical data4,075
(2)

In each case the fee includes the provision of information to one member State in the application; there is a further fee of £500 for each additional member State included in the application.