Licensing - TISIT

In Turkey, any plant protection product (PPP) considered for use in the plant health system must first be approved by the Ministry of Agriculture and Forestry in accordance with the Veterinary Services, Plant Health, Food and Feed Law No. 5996. No PPP that has not been approved by the Ministry can be used in plant health services! This approval process is referred to as licensing. The procedures and principles for the licensing of PPPs are outlined in the Regulation on the Licensing and Market Supply of Plant Protection Products, which is implemented based on this law. A PPP and its active ingredients can only be imported, produced, sold, distributed, and used once they have been approved by the Ministry in accordance with the regulations.

According to this regulation, there are four types of licensing in Turkey:

  1. Licensing of a PPP containing an active ingredient that is being used in Turkey for the first time.
  2. Licensing of a PPP that contains the same active ingredient already licensed under the first category, but in a different concentration, with the same formulation type.
  3. Licensing of a PPP that contains the same active ingredient in the same concentration as a previously licensed product, but with a different formulation type.
  4. Licensing based on a previously licensed PPP, also known as licensing by reference (EMSALDEN RUHSATLANDIRMA).

The active ingredients used in the PPPs must comply with FAO, WHO, and EU specifications.

The licensing documents for importation or production are issued for a validity period of 10 years. After this period, the PPP licenses can either be renewed by the Ministry for another 10 years, suspended, or canceled.

  1. Import licenses are issued for PPPs imported as finished products (ready-made) that meet the aforementioned conditions.
  2. Manufacturing licenses are issued for PPPs produced in Turkey (including contract manufacturing). The active ingredients used in their production, as long as they comply with FAO, WHO, and EU specifications, are usually imported from abroad.

Detailed information can be found in the PPP licensing regulation section of our website.

Companies operating in Turkey’s domestic and national PPP industry generally engage in commercial activities by obtaining licenses through the EMSELDEN RUHSATLANDIRMA (licensing by reference) system. It is therefore useful to touch on licensing by reference.

Licensing by Reference

A reference PPP is one that has already been licensed in Turkey and contains the same active ingredient in the same concentration with the same formulation type. Licensing by reference typically applies to PPP formulations that contain active ingredients whose patents have expired. It is illegal under the Industrial Property Law to produce, sell, or use PPPs containing patented active ingredients without permission from the patent holder. However, as long as no commercial activity is involved, this law does not prevent work aimed at obtaining a PPP license.