VISAD & Ministry rolled up their sleeves for sustainable cooperation

Turkiye VHP market is open to development

Burc Kunter

Veterinary Health Products Manufacturers Association (VISAD) Board of Directors Chair Burc Kunter made a comprehensive presentation to the participants, including the global and Turkish market status of the veterinary health products sector and the association's future goals. Kunter, by examining the current dynamics and priorities of the sector in detail, evaluated the growth and development opportunities in the Turkish market with global trends. In the presentation, it was stated that the global veterinary health products market will grow by 5% nominally and 6.4% in real terms in 2023. In the distribution by treatment areas, biological products are the leaders with a share of 30%, while anti-parasitic products account for 26%, anti-infectives for 14%, medicated feed additives for 10% and other products for 20%. Within the scope of regional market analysis, North America has the largest market share with 33%, while the Far East stands out as a notable region with 25%. While the annual compound growth rate (CAGR) in Turkiye's VHP market was stated as 1.3% in foreign exchange, it was reported that high growth rates were recorded in Turkish lira. The total market size reached 8 billion TL in 2023, and it was underlined that biological products were at the forefront with a share of 35% in the distribution by treatment areas in Turkiye, while antiparasitic products had a market share of 26% and anti-infectives had a market share of 24%.

We have priority areas to work on

Burc Kunter also detailed the work carried out by VISAD for sectoral development and the topics it focused on. She stated that issues such as GMP (Good Manufacturing Practices), DTS/BTS (Pharmaceuticals Tracking Systems), marketing permits and counterfeit/illegal product sales were priority areas in the sector. She particularly drew attention to the need to strengthen GMP practices with risk-based inspections and the importance of mutual recognition agreements to increase exports.

VISAD’s role is undeniable

Kunter emphasized that in order for the Turkish VSU market to realize its growth potential, it is critical to accelerate the entry of innovative products into the market, optimize legislative regulations and take steps to support exports. He stated that VISAD's role in this process is to direct improvement efforts in the sector and ensure compliance with global standards.

Burc Kunter’s presentation provided important information in order to understand the current status of the veterinary health products sector and to determine the priorities of the sector in light of global and local market analyses. The presentation provided a valuable perspective to the participants by revealing the steps that need to be taken to strengthen Turkiye’s position in the sector and create a more effective market structure.

We are not closed to the demands of the sector regarding improvements

Recep Tolga Kivanc

Dr. Recep Tolga Kivanc, Head of the Veterinary Health Products and Public Health Department of the Ministry of Agriculture and Forestry, provided information about the regulations, inspection practices and new legislative developments regarding the production and distribution processes of veterinary health products. He emphasized that the inspection processes are carried out with a risk-based approach with the improvements made within the scope of Good Manufacturing and Distribution Practices (GMP and GDP). He stated that GMP inspections are optimized according to factors such as the past scores of the facilities, personnel changes and product defects. He also stated that quality and traceability standards have been increased with updates made to legislations such as the GMP Inspection Instruction for Veterinary Medical Products and the Veterinary Pharmaceutical Warehouses Instruction, and that the physical and operational processes of veterinary pharmaceutical warehouses are subject to higher standards.

Sustainable growth and global competition

Dr. Kivanc, who also touched on the cost elements of inspection processes, detailed the impact of travel and logistics expenses on the budget and made comparisons with European and US examples. He stated that exports will be supported with GMP compliance and recognition agreements to increase Turkiye's global competitiveness in the veterinary health products sector, regular training will be provided to increase quality standards in the sector, and more effective data management systems will be developed in inspection processes. Finally, he emphasized that new regulations are of critical importance for the sustainable growth and global competitiveness of the veterinary health products sector, and expressed that cooperation with sector stakeholders will play a decisive role in Turkiye's achievement of its strategic goals.

Compliance with the EU will carry the sector forward

Dr. Taner Oncel

Dr. Taner Oncel, in his presentation titled VISAD Working Groups and Sectoral Assessments, addressed the fundamental issues of the veterinary health products sector such as marketing permits, GMP standards, DTS/BTS systems and combating smuggled/counterfeit products. Stating that the regulations made by the Ministry in the past years regarding marketing permits contributed to the sector, Dr. Oncel emphasized the importance of continuing compliance with the EU 2019/6 regulation and simultaneously introducing innovative products to the Turkish market. He said that the sector made large-cost investments in GMP inspections and that communication between the inspection team and facility quality units should be increased. He also stated that the sector expected that risk assessments based on scientific data should be taken into account in inspections and that different inspection models should be developed for low-risk facilities. He underlined that the inclusion of the Ministry of Agriculture in the PIC/S membership is a strategic goal for the sector in order to increase Turkiye's international recognition.

Fighting smuggled products and technological compliance

Stating that the sector provided great support in the monitoring of veterinary health products regarding DTS/BTS systems, Dr. Oncel touched on the importance of updates made for the system to work more efficiently. He stated that manual transfer of data from the systems used by companies increases the error rate and that they are working on more user-friendly solutions. Emphasizing that sales made especially over the internet pose a major threat to the sector in the fight against smuggled and counterfeit products, Dr. Oncel stated that the Ministry has developed measures such as an emergency reporting line by working in coordination with other public institutions. He said that joint studies are being carried out with the Ministry of Trade and other relevant institutions to prevent VTU sales over the internet and that completely blocking online sales of veterinary products, as is the case with human drugs, will be a critical step for the sector. At the end of the presentation, he stated that the process of harmonization with EU legislation supports the growth of the sector and that he is sure that it will adapt to future technological developments in the same way. It was emphasized that Turkiye's efforts to harmonize with international standards are critical in terms of sustainable growth and the introduction of innovative products to the market.

Marketing Permits can be made indefinite; but!

Mustafa Yıkılmaz

He comprehensively addressed the activities of the Marketing Permits Group within the General Directorate of Food and Control of the Ministry of Agriculture and Forestry in the 2023-2024 period. The content focused particularly on marketing permit processes, updates and process improvement targets.

Within the scope of 2023-2024 Activities, 265 files were examined in drug and immunological product applications, and it was emphasized that adaptation to the changing needs of the sector was achieved by focusing particularly on update requests. 550 files were evaluated in the commissions, 75% of which belonged to drug applications. In the non-medical products category, 130 new products were registered in 2023 and 158 in 2024, reaching a total of 1.560 products.

Within the framework of indefinite permit applications, it was aimed to make marketing permits indefinite, and it was stated that they would be canceled if no application was made. The planned regulations and improvements include preparation of new guidelines for good clinical practices, transfer of marketing authorization applications to electronic environment and regulations compatible with EU legislation. Mustafa Yikilmaz emphasized that the aim is to increase the competitiveness of the sector with electronicization, international harmonization and process optimization.

Good clinical practices will gain importance in veterinary medical products

Emre Paksoy

Ministry official Emre Paksoy, in his presentation, discussed in detail the importance of Good Clinical Practices (GCP) in the development process of veterinary medical products. Emphasizing that clinical studies should be conducted in accordance with ethical, scientific and regulatory standards, Paksoy stated that GCP aims to protect animal welfare as well as minimize negative effects on human and environmental health. The presentation highlighted basic principles such as ethical and scientific principles, protocol monitoring, education and competence, and animal welfare. In addition, the responsibilities of stakeholders involved in clinical studies, the work process, and application steps were detailed. Finally, the contributions of GCP to the sector were emphasized, and it was stated that it increased the reliability of veterinary medical products and ensured their compliance with ethical standards.

Pharmacovigilance and Veterinary Medical Product Tracking Systems

Ilyas Akbas, Asli Korel Turan

Ilyas Akbas discussed the systems aimed at increasing the traceability of veterinary health products within the Ministry of Agriculture and Forestry, and detailed processes such as E-Prescription, Drug Tracking System (DTS) and Biological Product Tracking System (BTS). Within the scope of “traceability systems”, it was stated that E-Prescription prevents drug residues with digital prescription and more than 15 million prescriptions have been issued as of 2023. DTS and BTS were emphasized as monitoring mechanisms that prevent the circulation of counterfeit and unlicensed products. It was stated that there are 10,686 retail points in Turkiye regarding the sale of “veterinary medical products”, and that special regulations have been made for wholesale and public enterprises. “In terms of usage statistics”, it was stated that 43.8% of prescriptions in 2023 belonged to antibiotics and 37.8% to antiparasitic drugs, with the Central Anatolia Region having the highest usage rate at 23%. Under the heading “Challenges and problems”, difficulties experienced in issues such as unlicensed product applications, raw material transfers and user changes were discussed; solution suggestions were shared. While Akbas emphasized that these systems play a critical role in increasing product safety and transparency of the sector, Asli Kortel Turan provided up-to-date information on pharmacovigilance regulations.

Frequently Encountered Problems and Solutions of the Veterinary Health Products and Public Health Department

Halim Kavak

In his presentation on frequently encountered problems and solutions of the Veterinary Health Products and Public Health Department, Halim Kavak addressed issues such as unlicensed product applications, raw material transfers and serial sales permits. While the integration of systems such as E-Prescription, DTS and BTS was emphasized for the tracking of veterinary health products, deficiencies in the market entry processes of unlicensed and R&D products, insufficient documentation in raw material transfers and delays in first series sales permits were stated as the main problems. While legislative updates, digitalization and training programs were suggested as solutions, Kavak stated that digital integration will enable the sector to achieve a safe and transparent structure.

We have carried out 440 GMP inspections in 11 years

Gencay Ergin, Husniye Dirican

Ministry official Gencay Ergin focused on inspection processes, costs, autovaccine production targets and planned legislative changes in his presentation where he discussed GMP and GDP regulations in the production and distribution processes of veterinary health products. Between 2013 and 2024, 440 GMP inspections were carried out and 19,443 findings were detected; 32% of these were major and 68% were minor. The highest number of findings was recorded in buildings and equipment (29%) and production processes (24%). Inspection processes can take between 7 and 720 days, and costs are 17,526 euros in Europe and 22,197 dollars in the USA. Autovaccine production sites are required to obtain GMP certification by the end of 2025, and more than 11 million doses have been produced as of 2024. GMP and GDP guidelines have been revised, and the digitalization of GMP applications via DTS aims to accelerate the process. Ergin emphasized that these regulations play a critical role in compliance with international standards and increasing the competitiveness of the sector, while drawing attention to the importance of providing more training and guidance to improve inspection processes. He also stated that the aim is to provide a more systematic and transparent structure for inspections with future regulations. Hüsniye Dirican shared the current developments at the Veterinary Medical Product Control Center.

Quality Agreements and Production Site Product Conformity Assessments

Mazlum Yoluk

Mazlum Yoluk detailed the legislative requirements and operational processes in his presentation on quality agreements and production site conformity assessments for outsourcing in the production of veterinary medical products. He emphasized that within the scope of “quality agreements”, contract quality agreements should determine the responsibilities between the parties in accordance with GMP standards. He stated that contract manufacturing processes should be organized with notary-approved agreements and be subject to Ministry inspection. He explained that in the “Manufacturing site and product conformity assessments” section, requests for adding new products or variations are made with tables submitted to the Ministry, and that physical environment requirements and GMP certificates are taken into consideration in this process. In the “General issues and annexes” section, he emphasized the importance of clearly defining the responsibilities of the parties in quality contracts, determining product release processes and regularly updating the annexes. As a result, quality contracts and conformity assessments play a critical role in ensuring compliance with GMP standards and traceability in the veterinary health sector.

New Regulations and Workflows in the Drug Tracking System (DTS)

Sadullah Fidan

In the presentation titled “New Regulations and Workflows in the Drug Tracking System (DTS)”, Sadullah Fidan conveyed innovations in the production, registration and sales processes of veterinary medical products. Within the scope of “production processes”, the conformity assessment of unlicensed and variation-subject products and approval processes of production instructions were discussed, and stock verification and validation steps were mentioned. “Downstream user identification processes” were managed with authorization processes on the DTS platform, while detailed post-production validations were carried out for the “sales approval process”. Thanks to “GMP and DTS compliance”, the traceability of the processes was increased, and production and variation processes were made faster. The presentation also shared information on how innovations in the system facilitate compliance with regulatory standards. The event concluded with a Q&A session and thank-you speeches.