The Ministry of Health may, within the consent to a specific therapeutic programme (hereinafter referred to as “STP”), impose an obligation on the applicant of STP to perform pharmacovigilance activities for the detection, reporting and evaluation of adverse reactions (hereinafter “AR”).
The Institute therefore publishes the following list of pharmacovigilance activities:
- The applicant of STP appoints and trains a person responsible for monitoring of STP with general pharmacovigilance training focused mainly on the transmission of suspected AR reports (according to GVP Module VI) and in the context of STP according to the article How to report an adverse reaction within a specific therapeutic programme? This person is also trained in the procedure of informing the Institute about the eventual death of a patient in connection with the administration of a medicinal product within STP. The report of suspicion of AR is submitted to the Institute by the applicant. In case the applicant is registered in EudraVigilance, it sends the report directly to the EudraVigilance system.
- The applicant shall train its employees for the receipt and transmission of AR reports related to the STP within the applicant's company – who reports what and to whom in what time frame within the company; this procedure is documented in the form of a standard operating procedure (SOP), resp. working instructions.
- The applicant sets up cooperation with distributors and centres to which the medicinal product in STP is delivered by the applicant and documents it- including procedures for transmission of intercepted AR reports to the medicinal product in STP - if relevant (ie applicant and centre where medicinal product is distributed, they are not the same company).
- The applicant shall keep in one place a clear record of received AR reports for the product in the STP, this record may be a part of the pharmacovigilance database of the applicant, if it is also the marketing authorization holder for other authorised medicinal products or if it operates the pharmacovigilance database. The applicant archives the source documentation for AR reports received directly by the submitter.
- In the case of a report with a missing minimum of information for a valid report (reporter, patient reaction, product - according to the reporting rules given in the GVP Module VI), in case of conflicting data or in case of missing information relevant to the overall assessment of the case, the applicant must make an attempt (attempts) to gather supplement information to the report (so-called follow-up), the attempts will be documented / recorded.
- In the case of such STP setting, in which there is a real possibility of reporting of ARs by healthcare professionals or patients directly to the Institute, the STP applicant shall request a summary of suspected ARs related to the product in STP, which were applicant directly to the Institute (request on the address farmakovigilance@suklcz). The applicant will then include the reports obtained this way into the safety assessment of the medicinal product for the given period in the regular program progress report.
- The applicant's person responsible for STP monitoring regularly monitors the information on the safety of the active substance within the STP published on the Institute, HMA and EMA websites.
- Medical literature monitoring to search for published adverse reactions of active substances within STP is not required, it is recommended only for an eventual evaluation of the safety of the product in STP in the program progress report.
Expert activity coordination department
27. 8. 2021