PASS – Post-Authorisation Safety Studies

Since when have the new rules for the Post Authorisation Safety Studies (PASS) been in force?

Where, when and how to register PASS? Which PASS are to be registered?

In what format shall the protocol be submitted (to PRAC and to SÚKL)?

In what format shall the final study report be submitted (to PRAC and to SÚKL)?

What are the Member States´ requirements for submissions of study documentation?

The most frequent safety studies conducted in the Czech Republic: PASS initiated, managed or financed by the MAH voluntarily – summary of obligations: