NON-MEDICAL VETERINARY HEALTH PRODUCTS

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NON-MEDICAL VETERINARY HEALTH PRODUCTS SERVICE

Non-medical veterinary health products are products prepared to be applied to the external parts such as skin, nails, teats, ears, or oral cavity of animals. These products are used for purposes such as cleaning, giving fragrance, altering appearance, protection, or maintaining good condition. They are non-drug products that have been made ready for use by passing through all production stages.

 

Our consultancy services regarding non-medical veterinary health products include:

  • Preparation of notification file in compliance with the Regulation for Non-Medical Veterinary Health Products
  • Label review or preparation of draft label within the scope of legislation
  • Preparation of SDS
  • Literature reviews
  • Finished product tests (mandatory and related to claims)
  • Free sale certificate

 

Notifications regarding non-medical veterinary health products are made to the Directorate of Veterinary Health Products and Public Health of the General Directorate of Food and Control of the Turkish Ministry of Agriculture and Forestry. Any changes made in the product or production site must be reported to the authority.

For the notification of non-medical veterinary health products, a code such as "production of non-medical veterinary health products, import, etc." related to the company's field of activity should be added first. In addition, a notification file must be prepared to make the notification.

 

What are the necessary documents in the notification file?

  • 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

 

How long does the Ministry review take?

After the application for notification of non-medical veterinary health products is made, the Ministry examines the application in terms of the above documents and within one month at the latest from the application date, informs the notifier whether the notification has been registered or rejected for reasons. If registered, the notifier can produce, have produced, import, and market their products with this document.

 

Who Can Be Responsible Personnel?

Notification holders appoint a person from the professional groups of veterinarian, pharmacist, chemist, or chemical engineer as responsible personnel. The responsible person is responsible for implementing production standards.

Notification holders must inform the Ministry when the responsible personnel leave their position and appoint a new responsible person. Until a new responsible person is appointed, the activities within the scope of this Regulation of the notification holders who do not appoint a new responsible person are stopped, and they are not allowed to produce new products, import, and market their products.

 

How Should Label Information Be?

Label information regarding non-medical veterinary health products must be in Turkish and in an easily readable and non-erasable manner. Information may be provided in different languages as well, as long as at least one of them is Turkish. In this case, the Turkish label is placed on the product in a non-removable manner.

Information that cannot fit in the inner packaging may be placed on the outer packaging. At least the following information must be included in the product label or usage instructions.

  • Trade name,
  • Name and surname, address, title, and production site address of the notifier,
  • Usage purpose of the product, types to be used, and method of use,
  • Information about storage conditions and shelf life of the product,
  • Production date, and serial number of the product.

 

What are the Inspection and Administrative Penalties?

There are certain inspections and administrative penalties related to non-medical veterinary health products. If a product does not comply with the provisions of the Regulation, the Ministry is authorized to collect or have them collected, to analyse them if necessary, to destroy them, or to have them destroyed.

Products that do not comply with the provisions of the Regulation are considered faulty. Products found to be faulty in inspections, of which the faults can be corrected, are collected from the market by the notifier. And after the improvement process, they can be put back on the market with the permission of the Ministry. Products that cannot be corrected or whose harms to human, animal, and environmental health have been definitively established are collected from the market and their ownership is transferred to the public for destruction. All expenses related to the destruction of products belong to the notifier.

Sanctions specified in the first paragraph of Article 37 (f) of the Law are applied to those who import, produce, or market products without notifying the Ministry, or who market the product differently from the notification and do not comply with the promotion of the products.

The Ministry may prevent notification holders who do not comply with the instructions for collecting, improving, or destroying products from operating activities related to non-medical products. Products that have been put on the market incorrectly twice are banned from production, import, and marketing for two years.

The General Directorate announces products that do not comply with the provisions of the Regulation on its website.

 

Registration Certificate (Notification fee) for Non-Medical Veterinary Health Products is 7723 TL for the year 2024.

For the List of Authorized Non-Medical Veterinary Health Products, click here.

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