Application for Marketing Authorisation ( MA )
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- Best Practice Guide on the Assessment Report for Mutual Recognition and Decentralised Procedures (July 2011) [Track version]
- Best Practice Guide on Break-out Sessions/Hearings (April 2016) [Track version]
- Mock-ups, Specimens and Samples for new applications (October 2016) [Track version]
- Member state agreement upon conditions under which the RMS can start the MRP/DCP (April 2016) Corrected [Track version]
Introduction to Published Papers on Validation has been taken off the website as it was considered to be obsolete.