Legislation
Currently, the state registration of pesticides and agrochemicals in Moldova is regulated by:
- Law no. 119 of 22.06.2004 “About phyto-sanitary means and fertilizers”
- Law no. 228 of 23.09.2010 “About plant protection andphyto-sanitary quarantine”
- Government Decision no. 897 of 08.12.1994 “About approbation and use of phyto-sanitary means and fertilizersin agriculture”
- Government Decision no. 1307 of 12.12.2005 “About approbation of Regulation for state certification and approval of phyto-sanitary means and fertilizers using in agriculture and silviculture”
Currently, the state registration of pesticides and agrochemicals in Moldova is entrusted to the Ministry of Agriculture, Regional Development and Environment of the Republic of Moldova.
Registration types/terms:
There are 2 types of registration: State Registration and Registration under Recognition procedure (in case the product is registered in EU and in a similar climatic zone).
- Experimental registration is approved for 2 years. (in case of lack of studies).
- Permanent registrationis approved for 7 years. The registration time is from 1,5 up to 3,5 years from the moment of submitting the application until obtaining the Registration Certificate (depends on product).
Application Deadline:
February each year – for State Registration.
Any time – for Recognition procedure.
Though we highly recommend to start document preparation in Aug – Oct of the year previous to the registration year.
Basic documents required to start preparing the application:
- COA of the product (formulation)
- *COA of the active ingredient (TC)
- MSDS of the product
- *MSDS of the active ingredient
- Certificate of the composition of the formulation
- * Certificate of the composition of the active ingredient
- Letter from the producing company of the formulation declaring the production of the formulation and giving permission to register the product (if producer and registering company are not the same)
- *Letter from the producing company of the A.I. (TC) declaring the production of A.I. (TC) and giving permission to register the product (if producer and registering company are not the same)
- Scan copy of the Registration Certificates of the product (formulation) from the country of origin
- Product dossier: toxicological reports (GLP studies) for the formulation and *TC, eco-toxicological reports for the formulation, and TC. Depend on product (pesticide or fertilizer) the number of studies and studies themselves are different.
- Registration Report (parts A,B,C) for products registered in EU.
* for pesticides, not required for other types of products
Studies that must be done locally:
- Biological studies (field trials) – 2 seasons.
- Adaptation of the methods of a.i. determination (in air, water, soil, plants and formulation)
- Toxicological assessment of formulation and TC (for pesticides) and studies (if not provided, GLP only)
- Eco-toxicological assessment of the formulation and TC and studies (if not provided)
- Hygienic studies
- Residue studies (for pesticides)
Above studies are not required for Recognition procedure if the products are registered in EU in the similar climatic Zone.
Cost of registration
The cost of registration can vary depend on product, number of crops you want to register your product for and number of studies (toxicological GLP, eco-toxicological) that were already done and provided.
