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

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

doi:10.33988/auvfd.1693413

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

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

References

ANSES (2022): Post-MA surveillance of veterinary medicinal products 2021 annual report, French Agency for Food, Environmental and Occupational Health & Safety. Available at https://www.anses.fr/en/system/files/ANMV-Ra-Pharmacovigilance2021EN.pdf (Accessed Apr 25, 2025).
ANSES (2023): Post-MA surveillance of veterinary medicinal products 2022 annual report, French Agency for Food, Environmental and Occupational Health & Safety. Available at https://www.anses.fr/fr/system/files/ANMV-Ra-Pharmacovigilance2022EN.pdf (Accessed Apr 25, 2025).
Bebek M (2022): Veteriner sağlık ürünleri sektörü faaliyetlerine ilişkin genel değerlendirme, TC-TOB. In: 2022 Yılı Veteriner Sağlık Ürünleri Değerlendirme Toplantısı. Antalya, Türkiye.
Capen R, Christopher D, Forenzo P, et al (2012): On the shelf life of pharmaceutical products. AAPS Pharm Sci Tech, 13, 911-918.
Chae HY, Lee CY, Park HC, et al (2022): National post-market surveillance assessment of veterinary medicines in Korea during 2018-2021. Prev Vet Med, 46, 206-211.
EDQM (2022): Working together to protect public health in Europe every day, European Directorate for the Quality of Medicines & HealthCare. Available at https://www.edqm.eu/documents/52006/71923/brochure-omcl-double-page-web.pdf/1b2e1f8a-17ce-49e4-5173-9390855c081b?t=1629096465234 (Accessed Apr 19, 2024).
EDQM (2025): 1.1.2 Compliance with the Ph. Eur., European Pharmacopoeia, 11th Edition, European Directorate for the Quality of Medicines & HealthCare. Available at https://pharmeuropa.edqm.eu/home (Accessed Apr 19, 2024).
EMA (1992): 3AQ11A, Specifications and control tests on the finished product, scientific guideline, European Medicines Agency. Available at https://www.ema.europa.eu/en/specifications-control-tests-finished-product-scientific-guideline#current-effective-version-8898 (Accessed Apr 25, 2025).

EMA (2003): ICH Topic Q 1 E evaluation of stability data, European Medicines Agency. Available at https://www.ema.europa.eu/en/documents/scientific- guideline/ich-q-1-e-evaluation-stability-data-step-5_en.pdf (Accessed Apr 25, 2025).
Fimbo AM, Maganda BA, Mwamwitwa KW, et al (2022): Post-marketing surveillance of selected veterinary medicines in Tanzania mainland. BMC Vet Res, 18, 1-8.
Kang J, Park HC, Jang YH, et al (2017): National post-market surveillance assessment of veterinary medicines in Korea during the past decade. BMC Vet Res, 13, 1-8.
Lee KJ, Kang J, Park SW, et al (2013): Post-market surveillance assay of veterinary medicines in Korea during 2009∼2012. Prev Vet Med, 37, 120-124.
TC-TOB (2010): 5996 sayılı veteriner hizmetleri, bitki sağlığı, gıda ve yem kanunu, Türkiye Cumhuriyeti Tarım ve Orman Bakanlığı. Available at https://www.mevzuat. gov.tr/mevzuat?MevzuatNo=5996&MevzuatTur=1&MevzuatTertip=5 (Accessed Apr 25, 2025).
TC-TOB (2011): Veteriner tibbi ürünler hakkında yönetmelik, Türkiye Cumhuriyeti Tarım ve Orman Bakanlığı. Available at https://www.mevzuat.gov.tr/ mevzuat?MevzuatNo=15651&MevzuatTur=7&MevzuatTertip=5 (Accessed Apr 25, 2025).
TC-TOB (2017): Veteriner tıbbi ürünler için iyi üretim uygulamaları (GMP) kılavuzu, Türkiye Cumhuriyeti Tarım ve Orman Bakanlığı. Available at https://www.tarimorman. gov.tr/GKGM/Belgeler/DB_Vet_Ilac/VTU_icin_GMP_Klavuzu.pdf (Accessed Apr 25, 2025).
TC-TOB (2024): Faaliyet raporları 2019-2023, Türkiye Cumhuriyeti Tarım ve Orman Bakanlığı. Available at https://www.tarimorman.gov.tr/Konular/Plan-Program-Ve-Faaliyet-Raporlari/faaliyet-raporlar%C4%B1 (Accessed Apr 19, 2024).
TC-TOB (2025): Bakanlığımızdan izinli veteriner tıbbi ürünler listesi, Türkiye Cumhuriyeti Tarım ve Orman Bakanlığı. Available at https://www.tarimorman.gov.tr/ Konu/979/Bakanligimizdan_izinli_veteriner_tibbi_urunler (Accessed Apr 25, 2025).
Tefera B, Bacha B, Belew S, et al (2022): Correction to: Study on identification, assay and organoleptic quality of veterinary medicines in Ethiopia. JoPPP, 15, 1-7.
VİSAD (2024): VİSAD hakkında, Veteriner Sağlık Ürünleri Sanayicileri Derneği (VİSAD). Available at http://www.visad.org.tr/sayfa/visad-hakkinda/3 (Accessed Apr 25, 2025).
Vidhamaly V, Bellingham K, Newton PN, et al (2022): The quality of veterinary medicines and their implications for One Health. BMJ Glob Health, 7, 1-18.
WHO (2017): Global surveillance and monitoring system substandard and falsified medical products, World Health Organization. Available at https://iris.who.int/bitstream/ handle/10665/326708/9789241513425-eng.pdf?sequence=1 (Accessed Apr 25, 2025).

Details

Primary Language

English

Subjects

Veterinary Pharmacology

Journal Section

Research Article

Authors

Onur Demir ^*
0000-0001-9076-3455
Türkiye

Farah Tatar
0000-0002-2701-5259
Türkiye

Muhammet Artan This is me
0000-0001-7136-1768
Türkiye

Mustafa Ekiz This is me
0009-0007-9520-125X
Türkiye

Gizem Karagülle Acet This is me
0009-0001-9291-0348
Türkiye

Mustafa Kesmen
0000-0002-6934-0463
Türkiye

Erdim Ozan Çakır
0000-0003-2816-1466
Türkiye

Tülay Çam This is me
0009-0004-2843-4748
Türkiye

Pınar Ersan This is me
0009-0005-0008-4368
Türkiye

Mevlüt Demirbaş This is me
0000-0002-0780-9545
Türkiye

Early Pub Date

November 4, 2025

Publication Date

January 1, 2026

Submission Date

May 27, 2025

Acceptance Date

October 23, 2025

Published in Issue

Year 2026 Volume: 73 Number: 1

DOI

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

IZ

https://izlik.org/JA29ES39UP

Cite

RIS / Bibtex

APA

Demir, O., Tatar, F., Artan, M., Ekiz, M., Karagülle Acet, G., Kesmen, M., Çakır, E. O., Çam, T., Ersan, P., & Demirbaş, M. (2026). Pre- and post-marketing quality surveillance of non-immunological veterinary medicinal products in Türkiye, 2018-2023. Ankara Üniversitesi Veteriner Fakültesi Dergisi, 73(1), 57-64. https://doi.org/10.33988/auvfd.1693413

AMA

1.Demir O, Tatar F, Artan M, et al. Pre- and post-marketing quality surveillance of non-immunological veterinary medicinal products in Türkiye, 2018-2023. Ankara Univ Vet Fak Derg. 2026;73(1):57-64. doi:10.33988/auvfd.1693413

Chicago

Demir, Onur, Farah Tatar, Muhammet Artan, et al. 2026. “Pre- and Post-Marketing Quality Surveillance of Non-Immunological Veterinary Medicinal Products in Türkiye, 2018-2023”. Ankara Üniversitesi Veteriner Fakültesi Dergisi 73 (1): 57-64. https://doi.org/10.33988/auvfd.1693413.

EndNote

Demir O, Tatar F, Artan M, Ekiz M, Karagülle Acet G, Kesmen M, Çakır EO, Çam T, Ersan P, Demirbaş M (January 1, 2026) Pre- and post-marketing quality surveillance of non-immunological veterinary medicinal products in Türkiye, 2018-2023. Ankara Üniversitesi Veteriner Fakültesi Dergisi 73 1 57–64.

IEEE

[1]O. Demir et al., “Pre- and post-marketing quality surveillance of non-immunological veterinary medicinal products in Türkiye, 2018-2023”, Ankara Univ Vet Fak Derg, vol. 73, no. 1, pp. 57–64, Jan. 2026, doi: 10.33988/auvfd.1693413.

ISNAD

Demir, Onur - Tatar, Farah - Artan, Muhammet - Ekiz, Mustafa - Karagülle Acet, Gizem - Kesmen, Mustafa - Çakır, Erdim Ozan - Çam, Tülay - Ersan, Pınar - Demirbaş, Mevlüt. “Pre- and Post-Marketing Quality Surveillance of Non-Immunological Veterinary Medicinal Products in Türkiye, 2018-2023”. Ankara Üniversitesi Veteriner Fakültesi Dergisi 73/1 (January 1, 2026): 57-64. https://doi.org/10.33988/auvfd.1693413.

JAMA

1.Demir O, Tatar F, Artan M, Ekiz M, Karagülle Acet G, Kesmen M, Çakır EO, Çam T, Ersan P, Demirbaş M. Pre- and post-marketing quality surveillance of non-immunological veterinary medicinal products in Türkiye, 2018-2023. Ankara Univ Vet Fak Derg. 2026;73:57–64.

MLA

Demir, Onur, et al. “Pre- and Post-Marketing Quality Surveillance of Non-Immunological Veterinary Medicinal Products in Türkiye, 2018-2023”. Ankara Üniversitesi Veteriner Fakültesi Dergisi, vol. 73, no. 1, Jan. 2026, pp. 57-64, doi:10.33988/auvfd.1693413.

Vancouver

1.Onur Demir, Farah Tatar, Muhammet Artan, Mustafa Ekiz, Gizem Karagülle Acet, Mustafa Kesmen, Erdim Ozan Çakır, Tülay Çam, Pınar Ersan, Mevlüt Demirbaş. Pre- and post-marketing quality surveillance of non-immunological veterinary medicinal products in Türkiye, 2018-2023. Ankara Univ Vet Fak Derg. 2026 Jan. 1;73(1):57-64. doi:10.33988/auvfd.1693413