Change of Product Registration Holder

Product Registration Holder can be defined as the company or corporate or legal entity in the field of pharmaceuticals whose name the marketing authorization has been granted. Product Registration Holder is responsible to all aspects of the product, including quality and compliance with the conditions of marketing authorization. The authorized holder must be subjected to legislation in the country that issued the marketing authorization, which normally means being physically located in that country. (Source: Glossary used in ACTD and ACTR).

Owing to the marketing reason, the product registration holder might need to transfer the holdership of their registered product. The holdership of a registered product can be transferred from existing product registration holder to a new product registration holder through a transfer procedure that allows the registered product to maintain the same registration number.

In JasCal Management & Consultancy, we are providing the service of applying abovementioned services in amending the particulars of registered products.