# The Medicines (Products for Human Use) (Fees) Regulations 2016, Paragraph 8: Decentralised procedure application


A decentralised procedure application is a major application, a complex application, a standard application or a simple application for a marketing authorisation for a medicinal product in respect of which at the time of the application—
(a) a marketing authorisation has not been granted in any EEA State; and
(b) an application for a marketing authorisation has been made in more than one EEA State under the procedure in Title III, Chapter 4 of the 2001 Directive.

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Source: https://www.legislation.gov.uk/uksi/2016/190/schedule/2/paragraph/8 (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-8
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.