The Division has two internal Units viz., Product Registration Section and Licensing Unit.

Product Registration Unit:

Medicinal product registration involves technical evaluation of the documents on the safety, quality and efficacy parameters of the medicinal products prior to approval for import and sale in Bhutan. The product sample submitted at the time of registration is also scrutinized to ensure its safety, efficacy and quality. Each medicinal product evaluation takes about two to three days by an expert. However, to reduce professional brassiness, each dossier is evaluated by all the experts each focusing on particular technical section.

Besides product registration, the unit also looks after the post registration changes of the product.

The cost control of the Medicinal products which is manufactured/ imported is also mandated to this unit to ensure that right pricing is done by the medicine wholesalers and retailers.

 

Licensing Unit:

For a person to sell and distribute or manufacture medicinal products, he/she must possess minimum qualification as determined by the Medicines Act and Bhutan Medicines Rules and Regulation to be considered for registration as a Competent Person with DRA. The unit then focuses on determining his /her competency to deal effectively with the medicines. .

For business operation either by retail or wholesale of medicinal products, technical authorization should be obtained prior to obtaining trade license from Ministry of Economic Affairs. This unit also issues import authorization for import of medicinal products into the country even for registered medicinal products so that only right registered medicinal products from the registered manufacturer is imported into the country.