Technical criteria
Ensure that the product meets the general protection goals established by national legislation.
Registration tools
Registration criteria
Verify that the product meets general protection goals and applicable scientific and legislative criteria.
Registration criteria translate general protection goals for human health, animal health and the environment into technical and scientific requirements applicable to the dossier.
Evidence-based approach
Align the dossier with statutory requirements that must be met before legal registration.
Legislative compliance
Bridge high-level legislative goals and the detailed technical principles applied during assessment.
Other tools
Continue exploring the regulatory framework
01
Registration strategies
Select an approach suited to available resources, evidence and the regulatory framework of the target country.
Open this section02Registration process
From pre-registration through review, every step supports a structured assessment of the application.
Open this section03Data requirements & testing
Define the studies needed to demonstrate product efficacy and safety through internationally accepted protocols.
Open this section04Assessment methods
Apply procedures and models suited to each scientific component of the dossier.
Open this section05Risk mitigation
Define effective, practical and communicable measures to reduce health and environmental risks.
Open this section06Decision making
Connect risks, values, alternatives and management measures to reach a regulatory decision.
Open this section07Registration criteria
Verify that the product meets general protection goals and applicable scientific and legislative criteria.
Open this section08Assessment of alternatives
Compare available options when a product is highly hazardous or its risks are difficult to manage.
Open this section