19/DRA/DC/Notification/2016-17/ 2970
Regulatory Notification
Conditions and requirement for product registration through multinational companies and Expedited Registration Process
In the efforts towards encouraging registration of medicines to promote availability of medicines in the country, the Authority is pleased to announce the following expedited route and conditions for registration of medicinal products effective from 15 May 2017:
1. 1 Definition of multinational companies:
A company having one establishment in one of the developed countries OR the product which is at least registered by two referenced National Regulatory Authorities as per Bhutan Medicines Rules and Regulation 2012.
1.2 Conditions/Documentation for multinational companies:
2.1 Definition of ER Companies:
Any manufacturing company fulfilling the following conditions:
2.2 Documentation for ER companies:
The application fee and certification charge will remain same as other routes of registration.
Drug Controller
Please click on the link below to view and download the regulatory notification:
November 3rd, 2023
October 13th, 2023
May 29th, 2023
March 29th, 2023
March 8th, 2023
February 7th, 2023