The pharmacovigilance system (collection, evaluation, and reporting of adverse reactions) should be set out by the applicant in the specific therapeutic programme (hereinafter referred to as “STP”) plan.
If the applicant is a marketing authorization holder for the product in another EU country, then it follows the GVP Module VI - reports from SpTP are so-called solicited reports (study reports). Reports are sent electronically by the applicant / holder directly to the EudraVigilance database in the standard time mode: serious within 15 days, non-serious within 90 days.
If the applicant is an entity that is not registered in the EudraVigilance system, the AR reporting takes place via State Institute for Drug Control (hereinafter “Institute”). The following system is recommended:
The person responsible for monitoring SpTP reports serious or unexpected adverse reactions within 15 days, non-serious within 90 days.
- by filling the CIOMS form and sending it by e-mail to farmakovigilance@suklcz or by post, or
- via the electronic web form for reporting the adverse reactions (hereinafter “AR”) to Institute.
In the electronic form as well as in the CIOMS form, it is necessary to state "medicine in STP" in the note.
If the applicant is an entity registered in the EudraVigilance system but does not hold a product with the same active substance as that in the STP, as a registered user of EudraVigilance, it reports electronically directly to the EudraVigilance database or use the reporting system via Institute, see above, both alternatives are possible.
We remind you that this concerns the adverse drug reactions reporting only - ie the reporter suspects a possible causal link between the administered suspect product and the adverse reaction. Adverse events from STP are not reported to Institute. The applicant records and evaluates them within the Interim / Final Report.
In the event of death or threat of the patient's life while using the product within the STP it is (apart from the actual reporting to EudraVigilance or Institute) necessary to inform Institute immediately by e-mail to farmakovigilance@suklcz within 7 calendar days.
Physicians, pharmacists, and other healthcare professionals are obliged to report suspicions of serious or unexpected side effects or other facts related to the use of a medicinal product, which they also encountered within the STP, immediately to the Institute pursuant to Section 93b of the Pharmaceuticals Act.