As from Jan. 10, 2013 the format was unified in accordance with the recommendation of the EMA Guidance on GVP – in the CZ it applies for all safety studies initiated after the effective date of the Amendment to AoP. On the basis of this recommendation an ENCePP checklist should be attached to the protocol. It is recommended to state all the chapters in accordance to EMA Guidance (and indicate N/A for parts which are not applicable to the specific study) and the order/numbers of the chapters pursuant to the GVP. The protocol should include the EU PAS register number of the study or be stated as “the study not registered in the EU PAS”.
In order to ensure compliance of the MAH with its pharmacovigilance obligations, the QPPV or his/her delegate should be involved in the review and sign-off of study protocols conducted in the EU. When applicable, the MAH´s pharmacovigilance contact person at national level should be informed of any study sponsored or conducted by the MAH in the Czech Republic and have access to the protocol. A copy of the protocol signed by the QPPV is to be archived for the reason of audits and inspections..
The reduced format of the protocol/abstract/final study report is also available at: COMMISSION IMPLEMENTING REGULATION (EU) No 520/2012 - Annex III
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