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. Multinational companies

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:

1. No past record of product recall or withdrawal from Bhutan (Voluntarily recalls by Manufacturers do not apply);
2. Letter of Authorization from the manufacturer(against the list of the products);
3. Documentary evidence as per the definition for multinational company;
4. Product sample (specimen of package, label/insert); and
5. Price structure- If applicable for all products.

2. Expedited Registration(ER) Process

2.1 Definition of ER Companies:

Any manufacturing company fulfilling the following conditions:

1. Minimum of 5 products with valid registration status registered with DRA for minimum of 2 years at the time of application;
2. No past record of product recall or withdrawal from Bhutan (Voluntarily recalls by Manufacturers do not apply);
3. Not more than 2 post registration change applied for a single product in one year; and
4. For parenteral products, at least ONE parenteral product to be registered amongst the 5 valid products.

2.2 Documentation for ER companies:

1. Letter of authorization from the manufacturer(against the list of the products)
2. Product sample (specimen of package, label/insert)
3. Price structure- If applicable for all products

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:

• Conditions and requirement for product registration through multinational companies and Expedited Registration Process