Data Exclusivity
Data exclusivity refers to the protection of the clinical and pharmacological data submitted by original drug manufacturer during the marketing authorization application process, for a certain period of time. During the term of this protection, generic drug manufacturers are not permitted to access or use these data directly in their own marketing authorization applications.
Data exclusivity is a significant regulatory measure aimed at safeguarding innovative products and encouraging investment in research and development.
SIMAJ is able to provide consultancy services to its clients in relation to the legal and administrative procedures that may arise in this area.
End-To-End Services
Our patent and trademark attorneys, each highly qualified in their respective fields, will guide you through every stage of the process, from application to registration, ensuring you take the most appropriate steps.