Dossier Compilation & National Registration
Agrochemicals
Dossier Compilation and
National Registration
APC provides a complete range of dossier compilation
services to enable you to achieve active substance and
product registrations in all EU Member States:
SERVICES
Sector
• Conducting new EU risk assessments to evaluate what uses can
potentially be registered
• Data Gap Analysis (DGA)
• Data Matching evaluations
• Technical Equivalence submissions
• Literature searches
• Managing regulatory studies and field trials
• Preparing and submitting active substance and product
dossiers
• Co-ordinating multi-company Task Forces
• Post submission follow-up with regulators
• MRL/Import tolerance applications
A product registration dossier should include:
Physical chemical properties
Validated methods of analysis
Acute toxicology studies and human risk assessment
Environmental fate and behaviour data with predicted environmental concentrations
Ecotoxicology studies and environmental risk assessment
Efficacy and selectivity trials
Classification and labelling
National Registration
APC’s network of national consultants can assist you with the
preparation of your Member State dossiers. Our experts are
experienced in the presentation of dossiers in dRR format, and
can advise where specific requirements apply to each Member
State, such as in the areas of environmental fate modelling and
risk assessment/mitigation.
We can also prepare labels and Material Safety Data Sheets
(MSDS) in the local language to comply with national
requirements. By having local experts in a wide range of EU
Member States, we can assist you at each step of the
submission process.
In addition to offices in the UK, France and Poland,
APC has offices in Brazil and Australia to help you
register your products in international markets.
APC . Cromwell Office Park . York Road . Wetherby . LS22 7SU . United Kingdom
Tel: +44 (0)1937 587962
Email: [email protected]
www.apc.eu.com