Notification for Non-Medical Veterinary Health Products

What are Non-Medical Veterinary Health Products?

Non-medical veterinary health products are products used to protect animal health, provide care, and ensure general hygiene, but they do not have the status of medicinal products. These products are primarily used for purposes such as cleaning, deodorizing, and protection.

Notification Obligations for Non-Medical Veterinary Health Products

According to the Regulation on Non-Medical Veterinary Health Products published in the Official Gazette of the Republic of Türkiye, any person wishing to manufacture, have manufactured, import, export, or place such a product on the market must notify the General Directorate. Products that have not been notified cannot be manufactured, imported, exported, marketed, or packaged.

Chemleg is ready to assist you in your notification procedures to ensure your non-medical veterinary health products can safely enter to the Turkish market.

What Should the Notification dossier Contain?

A notification dossier for a non-medical veterinary health product must include the following information:

• Address information of the person making the notification, trade registry gazette, signature circular,
• Qualitative and quantitative full structure of the product,
• Information on the physical, chemical, and microbiological properties of raw materials and finished products and their control,
• Information about the production site of the product, if subcontracted production is involved, subcontracting agreement (In addition to imported products, production site certificate and translation)
• Production method of the product,
• Scientific documents proving that the substances in the composition of the product are harmless or that the harms are negligible,
• Scientific documents claiming that the product can be used in the claimed area,
• Information about equivalent and similar products, ğ) Label and/or usage instructions of the product,
• Information about the inner and/or outer packaging of the product,
• Information about the shelf life and storage conditions of the product,
• Authorization certificate given by the authorization holder abroad for imported products,
• Commitment letter stating that the product falls within the scope of this Regulation, the documents provided are correct, and in case of the opposite, all responsibility is accepted.
• Information about responsible personnel; Diploma, Employment Contract, Activity Certificate (if any)
• Analyses if deemed necessary for the product

Key Points to Consider When Preparing a Notification dossier

Preparing the notification dossier correctly is essential for legally entering the market and avoiding potential issues. Compliance with the Regulation on Non-Medical Veterinary Health Products is mandatory.

Summary of points to consider when preparing the file:

1. Company and Responsible Person Information: Ensure the company’s activities are in line with the relevant sector and a qualified person is appointed as responsible.
2. Product Formulation and Production: All components of the product (quantitative and qualitative) and the production method should be specified in detail.
3. Proof of Safety and Efficacy: Scientific documents must demonstrate that the product is safe for animals, humans, and the environment and that it is suitable for the intended purpose (cleaning, care, etc.).
4. Turkish Label and Instructions for Use: The label and/or user instructions must be in Turkish and include all necessary information.
5. Legal Documents: For imported products, documents such as certificates of free sale and authorization from the country of origin must be included. A declaration of accuracy and acceptance of responsibility must also be attached.

Notification Process with Chemleg

The notification process for your non-medical veterinary products with Chemleg can be outlined as follows:

1. Preparation and Planning: First, it is confirmed whether the product falls under the category of non-medical veterinary health products. It is also checked whether the relevant activity field is registered in the company’s trade registry.
2. Dossier Compilation: Basic documents such as the company’s trade registry gazette and signature circular are prepared. Responsible person details are added, and the dossier is completed according to the regulation.
3. Application and Evaluation: The completed dossier and the receipt for the notification fee are submitted to the Ministry of Agriculture and Forestry, General Directorate of Food and Control. If there are deficiencies or non-compliances, time is granted to revise the dossier.
4. Notification Approval: If the dossier is found complete and compliant, the notification is approved. Afterwards, it must be ensured that compliance is maintained even after the product is placed on the market.

Chemleg, with its experienced team and sectoral know-how, prepares your notification dossiers and facilitates your legal compliance process.

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