In July, ANSM (the French medicine safety Authority) sent a questionnaire to all pharmaceutical companies in France to help prioritize Pharmacovigilance inspections and a guide to facilitate their completion.
This questionnaire is intended for operators concerned by the scope of ANSM Pharmacovigilance inspections, in particular all non-operating MA holders, all “exploitant” subsidiaries, all “exploitant” companies such as Medipha Santé, all MA holders marketing medicinal specialities in France from another country of the European Economic Area.
The objective of this questionnaire is to gather data on the pharmacovigilance system of operators at the national French level (the reference period to be considered for this questionnaire being between 01/01/2017 and 31/12/2019).
The questionnaire is made up of 13 sections, on all regulatory and operational aspects (PSMF, AEDS, product information, benefit-risk balance, etc.) and all questions are mandatory.
– Section 1: General information at the date of completion of the questionnaire
– Section 2: active substances for which a marketing authorisation is marketed in France on 31/12/2019
– Section 3: PV activities between 01/01/2017 and 31/12/2019
– Section 4: safety profile of products marketed in France between 01/01/2019 and 31/12/2019
– Section 5: QPPV Europe and QPPV France (RPV)
– Section 6: subcontracting the responsibility of QPPV Europe and/or QPPV France
– Section 7: PV Database
– Section 8: PV system audit and significance for PV
– Section 9: PV partnerships as of 12/31/2019
– Section 10: reporting deadlines between 01/01/2017 and 31/12/2019
– Section 11: activity(ies) outsourced externally as of 31/12/2019
– Section 12: Inspections
– Section 13: non applicable answers
The Excel questionnaire must be completed and returned before September 30, 2020 to avoid the penalty of a maximum risk score.
Our expert pharmacovigilance team will help you fill in the questionnaire. Do not hesitate to contact us!