Guidelines for Application for Registration of Medicinal Products - Kingdom of Bhutan
(2006; 10 pages)


The guidelines outlined in this document are primarily drawn up in accordance to the legal requirements of the Medicines Act of the Kingdom of Bhutan 2003 and Bhutan Medicines Rules & Regulation 2005.

All medicinal products, manufactured, sold, and distributed and imported/ exported from Bhutan should be registered under the provisions of the act. The pharmaceutical industry within or outside Bhutan intending to sell or distribute their products in Bhutan should register their products.

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