The publication of the new version of the
French Good Pharmacovigilance Practices in February 2018 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 earlier (link to our June2018 post here), 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 a Questions & Answers
Document to address the need for clarification. The wait was short and the ANSM
has now published this Q&A Document, 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 assessed in the corresponding PSUR and taken
into account in the evaluation of benefits and risks of Medicinal Products.
In the same way, the Q&A Document
clarifies 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&A Document also
clarifies the expectations regarding additional aspects of the local
Pharmacovigilance System including the responsibilities of the local contact
person for Pharmacovigilance, local PSMF, local Signal Detection activities and
Risk Management, etc.
___________________________
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 bulletin Safety Observer with regards
to the French announcements.
