The publication of the new version of the French Good Pharmacovigilance Practices in February 2018 (1) brought some confusion regarding the obligation for Marketing Authorization Holders (MAHs) and “Exploitants” to submit specific reports to regulatory bodies outside of the EudraVigilance network.
As mentioned in our post from June 2018 (2), we questioned the French Agency about the apparent additional requirement to submit Reports of Medication Errors with no Adverse Reaction, as well as Reports of Abuse or Dependence to medicines containing psychoactive substances.
The response we received brought valuable information and announced the imminent release of additional guidance to address the need for clarification. The wait was short and the ANSM has now published this list of Questions & Answers (3), which provides additional information on the role and obligations of the MAH and “Exploitant”.
In line with the response shared earlier, it confirms that there is no obligation for Pharma Companies to submit Medication Errors without adverse reactions to the dedicated ANSM Medication Error Desk. As already mentioned, all confirmed Medication Errors (with or without Adverse Reactions) must be evaluated in the corresponding PSUR and taken into account in the evaluation of benefits and risks of Medicinal Products.
In the same way, the Q&As clarify that there is no obligation for MAHs and “Exploitants” to submit reports of abuse or dependence to medicines containing psychoactive substances to the Dependence Evaluation and Information Center (CEIP).
These clarifications will be reflected in the French Good Pharmacovigilance Practices, which should be revised accordingly in the near future.
Please note that the Q&As also clarify expectations for additional aspects of the local Pharmacovigilance System including the responsibilities of the local contact person for Pharmacovigilance, local PSMF, local Signal Detection activities, Risk Management, etc.
(1) French guidance document – Good Pharmacovigilance Practices, February 2018: Link here
(2) Safety Observer article – “About the reporting of Medication Errors in France…”, 06-Jun-2018: Link here
(3) French Medicines Agency (ANSM) – Q&As on role and obligations of the MAH and “Exploitant”: Link here
Raphaëlle Kuhn is a Pharmacist with over 9 years of experience in the pharmacovigilance and clinical trial safety area. She has been working as a Pharmacovigilance Consultant within SUNNIKAN Consulting for 6 years where she supports clients in quality management activities and has conducted over 80 audits internationally.
Raphaëlle also contributes to the monthly Pharmacovigilance Regulatory Intelligence service Safety Observer with regards to the French announcements.