Pesticides Registration

1. Application  for  registration  in  Georgian,  Russian  or  English  languages(accompanied with  Special  Form  on Technical  Reglament- “Regulations of  Examines,  expertise  and registration  of  Pesticides  and  Agrochemicals in Georgia”, Decree  of  Government of Georgia #443 from 31 December 2013).

2. Full description (dossier)  of  pesticide  (active  ingredients  and  preparation  form)  that country where they are already registered (in the case of new active ingredients)

3. Document issued by the Applicant/producer that confirms the right of registration of active substance, preparation form of pesticide.

4. Short  Resume  according  to  the  accompanied  Application  (in  Georgian  language)- 4 copies.

5. Original packing label and Sample of label in Georgian language -4 copies (inclusive Risk phrases and Safety phrases); promotional material.

6. Safety  passport  (Material  Safety  Data  of  Substance -MSDS)  on  active  substances  and preparation forms.  

7. Required  analytical  methods  for  determining  active  ingredients  of  pesticides  (including channel implants, additions).

8. Determining methods of pesticides residues in agricultural products, water, soil, air and in biomaterials.

9. Analytical Standards of active ingredients (not less than 1 gr).

10.Product  examples  for registration field  examinations  in  two  climate  zones  (according  at the rate of use on hectares and quantities of treatment –about 2hectares for each plant) for new active ingredients.

11.Certificate  of  quality  or  analysis  (and  conformity,  hygiene  certificate or hygiene Conclusion when such exists).

12. Recommendations   about   storage, transportation of product and the methods of neutralization and liquidation.

13. Official Information from country of origin on regulated use of pesticides (Purpose of use, use   rate,   processing   methods,   time   of   application,   number   of   treatments   and   other requirements, pre-harvest period and limits on use). Recommendations on use of pesticide for those agricultural plants and against harmful organisms that are applied for registration.

14.  Official data of the country, which confirms that the active substance at the moment of registration  is  in  the  first  attachment  of  the  ECC  91/414  regulation/  regulation  (EC)No 1107/2009–in  the  Allowed  List  of  active  substances  for  EU  countries  or  in  EPA  List  of active  substances  in  USA – for  the  member  countries  of  the  Organization  of  Economic Cooperation and Development; product is in the List of Registered Pesticides of the country.

15. Confirmation profiles of plant protection products registration (name of country, registration certificate No, registration date and period, crops, harmful object, regulated use of pesticides) .

16. Information about the results of research of pesticide active substances and field research of pesticide preparation form, performed in the countries, which have equivalent climate and ecological conditions.  Plant  health  conditions  (specific  structure  of  harmful  organisms  and their   diffusion,   numbers,   intensity   of   development,   and   other   biological feature)   and agricultural  crop spices  are  equivalent;  Field  of  pesticide  use  is  equivalent;  Pesticide destruction  dynamic  and  customers  feeding  circumstances  are  equivalent.  Agricultural production  conditions  (agro technical    rules,  crop  growing  technologies,  plant protection systems,  pesticide  use  techniques)  are  equivalent  to  Georgia   -minimum  two  years  results (list of equivalent climate zone countries are attached).

17. Profiles from EU countries and USEPA: a) About classification of active substances and formulations in the dangerous class of Human Health.

b) About danger to the environmental organisms and recommendations for protection.

c) About  hygiene  requirements  for  active  substances  and  formulations      (ADI, maximum residue  level  (MRL)  in  food  products  and  agricultural  raw  materials, maximum  allowable concentration (MAC) in the water of community reservoirs; MAC in the air of the working zone, TSEL in the air of the working zone for the rest of the products; tentative safe effect level (TSEL) in atmospheric air (if appropriate);  MAC (for products manufactured in Georgia),      MAC in  the  soil  (for  stable  products  able  to  translocate  within  the  plant and migrate into neighboring media),  tentative allowable concentration (TAC) in the soil for the rest of products).

d) About destruction dynamics of the active substances and formulations (terms of destruction in the equivalent climate zones, in the agricultural products).

18. Profiles on the commercial secret documents.

19. Manufacturers standard on products manufactured in Georgia.

20. Report of registration tests for products manufactured in Georgia.

21. Information on patent validity for the active substance and preparation form (when such exists).

22. List of countries were active substances are registered if the patent validity is expired and List of countries were pesticide is registered for the equivalent purpose that is written in the registration form in Georgia.

23. Data protection request (when such exists).The period of data protection in Georgia is at list 10 year from pesticides first  registration (authorization) date.

24. Official assent of the first applicant for Pesticides registration (letter of access) that test and study reports those hi represent, may be used for benefit of next applicant (when such exists).

25. Official reports of their own test and study on active substance  of Pesticides and preparation form may be submitted if those are certified as compliant with the principles of good laboratory practice or of good experimental practice, or assessments of laboratories accredited in accordance with the rules set by Georgian legislation, or by laboratories that have international accreditation.

26. Confirmation profiles that Applicant/producers activities is allowed (certified, licensed, granted permission)

27. Demonstrative show of pesticide use in Georgia (when such exists).

28.Informationabout  history  of  registration  of  active  substance  and  preparation  form of pesticides in the other country,  and about  experience of pesticide use(Results of Biological and economic effectiveness of pesticides in the countries were they are already registered and use  (Sowing,  whether  registered active  substances or  not  more  than  5  year,  and registered pesticide or not more than 3 year; what share it has on the country market).