Reporting of adverse reactions to medicinal products in the post-registration period is important for pharmacovigilance carried out by the applicant/registration certificate holder and by the State Expert Center of the Ministry of Health of Ukraine, as the authorized body for pharmacovigilance at the national level.
With the aim of developing the pharmacovigilance system of Ukraine, starting from January 2017, medicinal product safety data, namely information on adverse reactions to a medicinal product, vaccines, tuberculin and/or an adverse event following immunization/tuberculin diagnostics, as well as on lack of efficacy of a medicinal product, is entered through the Automated Pharmacovigilance Information System (APIS).
From anywhere in Ukraine at any time, healthcare professionals, applicants, and patients can use the link https://aisf.dec.gov.ua to visit the AISF website, fill in the required fields to enter information on a case of an adverse reaction or lack of efficacy of a medicinal product, and send it to the Center. AISF is simple, fast, and free.
Following the example of many years of experience in European countries and taking into account national pharmacovigilance requirements, to enable the submission of reports of adverse reactions and lack of efficacy of medicinal products, we recommend including in the package leaflet of the medicinal product information on the importance of reporting adverse reactions and lack of efficacy of the medicinal product, with a link to the AISF and, if desired, the applicant's contact details through which adverse reactions and lack of efficacy of the medicinal product can be reported.
It is advisable to state the information in a separate paragraph at the end of the “Adverse reactions” section of the instructions for medical use of the medicinal product.
For example:
“Reporting of adverse reactions after registration of a medicinal product is important. It allows continued monitoring of the benefit/risk balance of the use of this medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of the medicinal product through the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua .”
Since in Ukraine the information on a medicinal product is presented in a single document – the instruction for medical use of the medicinal product, intended for both healthcare professionals and patients – the template of the proposed text combines the text format of the summary of product characteristics and the package leaflet.
