BIOLOGICAL EFFICACY TRIALS

Fitomed conduct biological efficacy trials and report by following standard trail methods published by General Directorate of Agricultural Research And Policies (TAGEM), an organization of Republic of Türki̇ye Ministry of Agriculture And Forestry.

The registration trials of plant protection products are divided by formulation types in Türkiey. There are 3 types of registration of plant protection products on the basis of Regulation of registration and market placement:

Types of registration:

 

  • Registration of new pesticides according to new actives.
  • Label extension: registration of registered pesticides on different crops and/or pests.
  • Registration of generic pesticides

 

*Registration of new pesticides according to new actives.

The registration of new active in Türkiye requires to submit 2 Biological Assessment Dossiers (BAD) for each crops and pests and in 2 geographical locations at least for open field or greenhouse uses and 2 in open field and 1 in greenhouse for both open field and greenhouse uses along with residue analysis reports to Republic of Türki̇ye Ministry of Agriculture And Forestry. The registration process also requires submission of toxicologic and eco-toxicologic properties, environmental impact, residue on food and water, effect on beneficial fauna., mutagenic, teratogenic, and oncological properties., biological properties., chemical and physio-chemical properties. The new active gets registration on the basis of all of these reports.

 

*Label extension: registration of registered pesticides on different crops and/or pests.

The label extension of registered product requires to submit Biological Assessment Dossier (BAD) on different crops or on same crop but different pests. The residue analysis report also requires if the product has different formulations.

*Registration of generic pesticides

Registration of generic pesticides is possible for the actives and different formulations of the actives after the expiration of patent of that active. It is not possible to register a product without the permission of the patent owner if the patent is not expired. Generic products are the same as the original products containing the same actives and have same formulations. They have the same properties, mode of actions, and efficacy of the original products. They do not have any negative impact on targeted crops and the environment. In general, the local companies registered generic products. The registration of generic products occurred after the expiration of patented products and production of the product legally by any other companies. It is illegal to register a patented product as a generic product and is not possible.