Regulatory Notification

August 10th, 2017

19/DRA/DC/Notification/2016-2017/84

Notification on reduction in number of product samples requested during submission of dossiers

DRA notifies all the Market Authorization Holders (MAH) that the number of product sample requested during submission of dossiers for registration of medicinal products has been reduced to one unit of sample. However, samples will be asked as and when deemed necessary by the Authority. This notification shall come in force retrospectively from 1 August 2017.

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