Communication to industry on Clones and Replicas

Communication to industry on Clones and Replicas

A clone is defined as an application submitted by the Innovator as a copy of its own product under a different proprietary name at any stage during the product life cycle. A replica is defined as a copy of an already registered generic product, submitted by the same or by another applicant at any stage during the product life cycle.

2020 Nov

Download latest version
File Type: pdf
Category: Communication to industry
Unit: General ECTD & human medicines