Update of the PHV-4 Guideline

Information on SUKL’s update of the PHV-4 Guideline.

From 20 December 2016 the updated guideline PHV-4 version 5. Electronic reporting of the adverse drug reactions has been in force. Amendments in this Guideline follow up on the revision of the Guideline KLH-21 – version 6 in which the obligation of clinical trial adverse drug reports (SUSAR) parallel submission to SÚKL has been cancelled.

Original source.

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