Bhutan Medicines Board

Registration Guidelines

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Drug Regulatory Authority

Ensuring safety, efficacy and quality of medicinal products .

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List of Registered Drugs

Registered Drugs with Drug Regulatory Authority

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WHO Pharmaceuticals Newsletter

The aim of the Newsletter is to disseminate information on the safety and efficacy of pharmaceutical products

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Announcements

Announcements by Drug Regulatory Authority

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Drug Regulatory Authority
Vacancy Re-Announcement PDF Print E-mail
Written by Administrator   
Monday, 30 January 2012 00:00

Office of the Drug Controller, Drug Regulatory Authority (DRA), Thimphu is pleased to announce vacancy as follows:

Sl. No.

Position Title

Position Level

Slot

Minimum Qualification

Remarks

 

1

Chief Regulatory Officer

 

P1 A

 

3

Bachelors in Pharmacy/Pharmacology with training in relevant fields/Mgt & pharmaceutical research & policy

For Registration, Inspection and Post Marketing Control Division

Interested in-service civil servants who meet the eligibility criteria (section 7.3.2 of the Promotion Rules and Regulation) as per BCSR 2010 may apply to Drug Controller. Applications should reach DRA latest by 9th February, 2012 with the following documents.

i. Curriculum Vitae

ii. Academic/technical/professional testimonials

iii. No objection certificate from the employer and

iv. Citizenship identity card copy

For further information contact DRA at 337074/337075

Last Updated on Monday, 30 January 2012 15:23
 
Recommendations made by the medicine wholesalers during the workshop. PDF Print E-mail
Written by Administrator   
Thursday, 15 December 2011 11:58

Drug Regulatory Authority is pleased to inform that the recommendations made during the consultative workshop with the medicine wholesalers for three days w.e.f 17th November, 2011 has been endorsed by the Hon’ble chairperson of the Bhutan Medicines Board vide note sheet no. 10/DRA/DC/2011-12/947 dated November 24th, 2011. Accordingly, following notifications are served for strict compliance by the medicine wholesalers:

  1. One time renewal of the registration of the medicinal product will be done with minimal documents as laid by the DRA and agreed by the medicine wholesaler. However, subsequent renewal shall be done as initial registration. For such renewal, the application for renewal must be submitted before the expiry of the registration. After the expiry, one month grace period will be provided and maximum of two months. With a daily fine of Nu. 100 will be considered for renewal.
  2. To encourage more registration of the medicines while ensuring accountability of the medicinal product, recall and withdrawal of the medicines, if necessary; only Market Authorization Holder will be permitted to import medicines registered by him/her. However, to ensure availability, the Market Authorization Holder shall retain minimum of 30% stock balance supplied to the private at all times.

As approved, these notifications shall be implemented effectively by DRA from 1st January 2012.

Last Updated on Wednesday, 04 January 2012 12:11
 
Requisition for Pharmacy Technicians PDF Print E-mail
Written by Administrator   
Friday, 18 November 2011 15:49

Drug Regulatory Authority in collaboration with the Department of Human Resources, Ministry of Labour and Human Resources and the Royal Institute of Health Sciences has signed on an agreement to train five candidates in the field of pharmacy. Therefore, DRA would like to notify all the registered wholesalers/retailers to put requisition on or before 15th Dec 2011.

To view the notification please: Click here

Last Updated on Friday, 18 November 2011 16:00
 
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