Report form
Due to significant changes in EU legislation on the conduct of pharmacovigilance, the need to regulate relationships between entities involved in the circulation of medicines in order to adequately use the personnel and technical capacity of each of them, avoid duplication of functions, and include all participants in the process of using medicines in the reporting of adverse reactions to medicines, amendments and additions were made to the current legislation of Ukraine on the conduct of pharmacovigilance by MoH order of 29.12.2011 No. 1005 "On Amendments to the MoH Order of 27.12.2006 No. 898".
From 02.04.2012, after the entry into force of MoH order No. 1005, information on cases of adverse reactions and/or lack of efficacy of medicinal products must be submitted not only by doctors, but also by nurses, feldshers, midwives, pharmacists and pharmacy specialists. Patients, their representatives and patients' rights organizations will also be involved in this process.
Modern approaches to drug safety surveillance in Ukraine provide for collecting information on all medicinal products, including medical immunobiological preparations. In this connection, the form of the report card has been changed. The updated card includes fields that make it possible to fully collect information, with subsequent analysis, on adverse reactions to vaccines, toxoids and tuberculin allergen.
- Adverse reaction (AR) report form for patients or their representatives and requirements for completing it, in accordance with Annex 2 to the Procedure for pharmacovigilance.
- Adverse reaction (AR) report form for medical and pharmaceutical professionals in accordance with Annex 6 to the Pharmacovigilance Procedure.
