Pre- and post-marketing quality surveillance of non-immunological veterinary medicinal products in Türkiye, 2018-2023

Year 2026, Accepted Papers, 1 - 8

Onur Demir , Farah Tatar Muhammet Artan Mustafa Ekiz Gizem Karagülle Acet Mustafa Kesmen , Erdim Ozan Çakır , Tülay Çam Pınar Ersan Mevlüt Demirbaş

https://doi.org/10.33988/auvfd.1693413

Abstract

Pharmaceutical quality studies of veterinary medicinal products at the pre- and post-marketing authorization stages are important for the pharmacoepidemiological assessment of product quality determining risk factors for non-compliance and the necessary measures. This study aimed to conduct a pharmacoepidemiological assessment of the results of quality control studies performed on non-immunological veterinary medicinal products pre- and post-marketing authorization. For this study, 1827 products were collected at pre-marketing authorization stage and 692 samples were collected at post-marketing stage. Non-compliance rates between pharmacological groups and between pre- and post-marketing stages were statistically evaluated with a 95% confidence level and a 0.05 margin of error. Significant differences were found the level of non-compliance between pre- and post-marketing authorization stages. Significant differences were found in terms of the level of non-compliance, between pharmacological groups. No statistically significant trend has been observed in the level of non-compliance over the years at the pre-marketing, post-marketing stages, combined non-compliance rates, and pharmacological groups' trends. Although the overall non-compliance rate is low, there have been notable increases in certain years for vitamins, minerals and antiparasitics. The non-compliance rates in Türkiye are at low levels thanks to the international harmonization of legislation of veterinary medicinal products, good manufacturing and distribution practices in the sector, and the operation of quality assurance, quality control and pharmacovigilance systems. However, non-compliant products may always exist in the market. This control and surveillance system should be continuously updated and maintained to reduce the risk and address problems.

Keywords

Non- immunological veterinary medicinal products , One Health , Pharmacoepidemiology , Quality control , Türkiye

Project Number

-

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