CMDh updates best practice for PSUR work sharing

The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) has revised its best practice guidance for transitional arrangements for PSUR work sharing. The guide is intended to facilitate the completion of the informal European Work Sharing of PSURs for Nationally Authorised Products (NAPs).

The principles for submissions and evaluation have also been updated to specify the required process for submitting PSURs to National Competent Authorities (NCAs) for products authorised via National Procedure, MRP and DCP. Assessment reports will now be published on the CMDh website and therefore additional steps have been added to ensure compliance.

For more information visit the CMDh website

If you are planning PSUR submissions and would like our expert input into the preparation and/or submissions of the reports, please contact us on info@revipharm.es