Source: http://esticon.com.pl/en/plant-protection-products-ppp/
Timestamp: 2020-06-03 06:09:24
Document Index: 66500886

Matched Legal Cases: ['art. 33', 'art. 43', 'art. 51', 'art. 40', 'Art. 52', 'art. 54']

Plant Protection Products (PPP) – Esticon
ApplicationsData gap analysis (DGA) & preliminary risk assessment (PRA)Planning and coordination od studiesPPP dossier (dRR)Comparative assessment
We prepare and submit on the behalf of client applications for PPP in accordance with Regulation 1107/2009:
zonal registration (art. 33) and renewal of authorisation (art. 43)
extension of authorisation for minor uses (art. 51)
mutual regognition (art. 40)
parallel trade (Art. 52)
research and development (art. 54)
transfer for authorisation (authorisation’s holder change)
Data gap analysis (DGA) & preliminary risk assessment (PRA)
ESTICON initially evaluates completeness of existing documents and studies by conducting data gap analysis (DGA) for plant protection product in accordance with Reg. 283/2013 and Reg. 284/2013. In case of data waiver, ESTICON determines additional trials to be conducted and possibility to use unprotected data or Letter of Access. ESTICON performs assessment of registration possibilities by preliminary risk assessment (PRA) in which we identify areas of concern.
Planning and coordination od studies
ESTICON supports its clients in selection of necessary data and studies necessary for positive evaluation of plant protection product during registration process. We oversee ongoing studies as well as review study plans and final reports in order to ensure studies are designed and met the specific requirements for which they are needed.
Additionally, on the behalf of our clients we choose facilities conducting studies and negotiate prices. We cooperate only with prestigious laboratories and facilities specializing in tests for plant protection products.
PPP dossier (dRR)
ESTICON prepares registration dossier (dRR) for plant protection products. We prepared zonal registration dossier as well as National Addenda including only specific national requirements or data that are provided at national level. Dossier is prepared in accordance with the current requirements concerning risk assessment for operator, bystander, resident, worker, consumer and NTO and latest versions of modelling tools for PEC calculations. Dossier is provided in Word/PDF or CADDY format.
For plant protection products containing active substances classified ac candidate for substitution (CfS), ESTICON prepared in accordance with Reg. 50 Reg. 1107/2009 Comparative Assessment (CA). Comparative Assessment for plant protection product is conducted at national level taking into account EU guidance SANCO/11507/201 and national requirements.
Do you need help registering plant protection chemicals, fertilizers or adjuvants, preparing registration dossiers, labels or Safety Data Sheets?