Additional medicine monitoring


The Department of Pharmacovigilance and Monitoring of the Safety, Effectiveness and Quality of Medical Devices (hereinafter-DPMSEQ&MD) presents the "List of Medicines Requiring Additional Monitoring", medicines under additional monitoring have a black inverted triangle, which must be reflected in the instructions for medical use, together with a short phrase explaining what the triangle means "▼ This medication is subject to additional monitoring, which will quickly establish new information about the safety of the medicine. We ask health care professionals to report any suspected adverse reactions."

Holders of registration certificates for medicines on the List should also update the information about the medicine to include the new black symbol and make changes to the instructions for medical use using the latest version of the updated summary drug formulary (SmPC). If only the INN is indicated, registrants need to amend all medicinal products with the same INN according to the latest version of the summary of the original medicine.

Holders of registration certificates of medicinal products must apply for changes in the general characteristics of the medicinal product within 90 calendar days from the date of publication of the information on the website, otherwise a letter will be sent to the regulatory authority for appropriate regulatory action.

Post-authorization safety studies (PASS): A post-registration safety study of a drug conducted to identify, characterize a safety hazard assessment, confirm a drug's safety profile, or measure the effectiveness of risk management measures. PASS results, once completed, must be submitted to the DPMSEQ&MD.  

If a medication is marked with a black triangle, it means that it is more closely monitored than other medications. This is usually because the drug has less information available than the other drug, for example, it is new to the market or there is limited data on its long-term use.