6. Processes for handling and investigating alerts

Almost all prescription medicines are within scope of the medicines verification system. All their batches released after February 9, 2019, must be labeled in accordance with the requirements of Delegated Regulation (EU) 2016/161 and any system alerts related to them must be considered suspected falsified medicinal products and resolved in accordance with regulatory guidelines and the users’ own approved procedures. See also Roles & Responsibilities in chapter 7.

The Finnish Medicines Agency Fimea has published information on the safety features of medicines on their website.

The following paragraphs describe alerts, their possible root causes, and procedures for handling alerts. The measures are grouped according to the different actors in the distribution chain. Note that the root cause of the alert is not necessarily connected to the actor that triggers the alert (for example, the root cause of an alert in the pharmacy might be the fact that the batch data has not been uploaded to the system by the pharmaceutical company).

Alert processing and investigations proceed according to a three-tiered classification:

  • possible suspected falsification: an alert to be investigated with the MAH and / or FiMVO
  • suspected falsification: an alert for which any technical or process-related reason has been ruled out indicating a suspected falsification or product defect, which is to be handled and reported by the MAH in accordance with the Fimea regulation on reporting of product defects and suspected falsifications
  • confirmed falsification, whereby the MAH acts in accordance with a class 1 product defect process.

This guideline is based on the knowledge and experience gathered by FiMVO as well as similar experiences and insights gained through European cooperation.