Post-Authorisation Safety

They must concern regulatory approved products used in approved indications and can include, but not only, non-interventional trials, observational trials, post-marketing surveillance and post-authorisation safety studies. 

A lack of proactive and proportionate monitoring including a lack of risk management and structured data collection in the form of post authorisation safety studies. 

Note for Guidance on the Electronic Data Interchange (EDI) of Individual Case Safety Reports (ICSRS) and Medicinal Product Reports (MPRS) in Pharmacovigilance during the Pre-and Post-Authorisation Phase in the EEA (EMEA/115735/2004) (Eudra Vigilance TIG adopted September 2004)... 

There should be a clear starting point or specification of what is already known at the time of licensing a medicine and what is required to extend safety knowledge post-authorisation. 

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