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SAM substantially shortens the time of review of applications for change of marketing authorisation holder


The State Agency of Medicines (SAM) has been able to halve the time of expertise in case of change of marketing authorisation holder (MAH) to allow companies to change the MAH of medicines in a timely manner, thus, being more flexible in work planning and reducing the bureaucratic burden.

Starting from 1st of December SAM will provide this service to clients within 30 days after a positive primary expertise, instead of 60 days as it was previously.

In order to change the MAH, the company has to submit to SAM an application for a type II (A.z) variation.

More information about change of MAH is available on SAM’s website section “Industry > Marketing authorisation holders > Post-authorisation > Transfer of Marketing Authorisation Holder” (click here).