Licensing of Veterinary Medicinal Products
Licensing of veterinary medicinal products is a mandatory procedure as per a regulation issued by the Ministry of Food, Agriculture and Livestock in 2011. In accordance with the Regulation on Veterinary Medicinal Products, which entered into force after being published in the Official Gazette No. 28152 by the Ministry on 24 December 2011, a license is required for many products to be placed on the market. The sale of products that do not have a veterinary medicinal product license, that is, without a marketing authorization, is not allowed. For this reason, manufacturers / importers that need to obtain a license must apply to the Ministry for the licensing of veterinary medicinal products with the application file they prepare.
How to Get a Veterinary Medical Products License?
We can summarize the licensing stages as follows:
? Real or legal persons who want to obtain a product license submit the file they have prepared to the Ministry.
? After a maximum of 30 days of preliminary examination, the files found suitable for the application file are sent to the relevant commission for the actual evaluation.
? In case of a possible non-compliance, the application is rejected and the applicant is notified of the refusal with the reasons.
? After the deficiencies and nonconformities are eliminated, the applicant company makes a new application and the process continues.
? The commission that examines the application file makes a comprehensive evaluation by considering many parameters. At this stage, issues such as the product´s safety, effectiveness, usefulness, pharmaceutical suitability, quality, whether it is healthy, whether the dossier is prepared according to the determined guideline, etc. are analyzed.
? The Ministry may request additional information the applicant during the evaluation phase or may wish to visit the facilities where the product is produced, tested or subject to control.
? As a result of all these stages, companies that fully meet the requirements of the Regulation on Veterinary Medical Products are granted a license.
Veterinary Medical Products License Application Documents
The main documents required when applying for a veterinary medicinal product license are:
? Diploma, identity card information and passport photo of the marketing authorization officer
? If the application is made on behalf of a responsible legal entity, the employment contract with the relevant institution
? Contact information of marketing authorization officer
? If an application is made on behalf of a legal entity, a trade registry document
? Plans to be followed in case of possible product recall and those responsible for this process
? Quality management system documents
Who Can Get Veterinary Medicinal Products License?
Natural persons who are chemical engineers, chemists, veterinarians and pharmacists and legal entities employing these persons in their institutions can apply for veterinary medicinal product licensing. According to the product characteristics, the professions of the people and the competencies of the personnel that the institutions should employ may change. Public institutions or other legal entities designate persons belonging to these professions as marketing authorization holders. Marketing authorization holders can offer their products to the market after receiving the sales authorization document.
Veterinary Medical Products Licensing Consultancy Service
Organizations that want to obtain a veterinary medicinal product license should definitely get support a consultancy firm in this process. Because consultancy firms guide companies in all steps of the application and certification process and can follow the process on their behalf. If companies want their sales activities to be carried out smoothly, quickly and safely, they should carry out the veterinary medical product licensing process with a consultancy firm that provides quality services.
