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

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Version: 1
Date Updated: 26/11/2020
File Type: pdf
Category: Communication to industry
Unit: General ECTD & human medicines