All Centralised Procedure articles
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Journal
European regulatory fees – complexity, concerns and solutions for efficiency
Regulatory authorities charge fees for the services they provide related to marketing authorisations. This research aimed to understand the complexity and concerns around the fee calculation and payment process for EU procedures used for market approval of a drug and proposes potential solutions to improve efficiency.
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Journal
Key steps and considerations of the EU centralised procedure
This continuing professional development article aims to provide some of the background and key steps and considerations when using and navigating the EU centralised procedure for a new marketing authorisation application (MAA).