Home
Notification to Market Authorization Holders.
- Details
- Published on Wednesday, 09 May 2012 13:33
All the Market Authorization Holders who have registered the medicines with the Authority are requested to check the validity status of the products registered.
As agreed by the medicine wholesalers in November 2011, the renewal with minimal documents will be considered for 3 months after expiry of registration. If the application for the renewal with specified documents is not submitted within specified time, the renewal will then be considered upon submission of all the documents as submitted during initial registration.
Furthermore, please note that as informed earlier, if the registration has expired after your products are imported into the country, they will be considered not valid and shall be treated as unregistered products.
This notification is issued for strict compliance by the Market Authorization Holders.
Chief Regulatory Officer
Registration Division, DRA
Draft Regulation for Blood and Blood Products
- Details
- Published on Wednesday, 09 May 2012 13:32
Draft Regulation for Blood and Blood Products As Human Blood and Blood Products, due to their therapeutic nature shall be declared as medicinal product by the Bhutan Medicines Board, its regulation becomes necessary under the Medicines Act of the Kingdom of Bhutan 2003, mandating Drug Regulatory Authority to institute a Regulation for the same.
Revised Bhutan Medicines Rules and Regulation 2012
- Details
- Published on Wednesday, 09 May 2012 13:33
Drug Regulatory Authority of Bhutan is pleased to announce that the revised Bhutan Medicines Rules and Regulations will be implemented from 1st August 2012.
Prior to enforcement, sensitization on the revised and new sections will be carried out to all the stakeholders.
