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.
Please click on the link below to view and download the regulatory notification:
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