1. Regulatory Notification on mandatory submission of testing report for ethylene glycol and diethylene glycol in oral liquid preparations.

2. Regulatory Notification on amendment for requirement of registration certificates from 2 NRAs.


Notification Title
Regulatory Notification On Requirement Of Import Authorization For Prioritized List Of Medical Devices.
Regulatory Notification On Revised Document Requirement For Medical Devices Registration.
Regulatory Notification: Regulation of Drug of Abuse test kits.
Regulatory Notification: Cancellation of Marketing Authorization of Orphylline (Theophylline 69 mg+Etophylline 231 mg Tablets).
Regulatory Notification on rescheduling of clients visiting time for efficient service delivery.
Regulatory Notification on Substandard (contaminated) paediatric medicines identified in WHO region of Africa.
Regulatory Notification on Requirement of Technical Authorization for sales, distribution of Medical Devices and Registration of Medical Devices
Regulatory Notification for Mandatory Submission of e-dossiers and Sample Submission
Regulatory Notification on Requirement of Emergency Use Authorization (EUA) for Import, Sale and Distribution of COVID-19 self-test kits
Regulatory Notification on Sale, distribution and use of COVID-19 antigen self-test Kits
Regulatory Notification: List of Manufacturers Eligible for Product Registration via Company recognition
Regulatory Notification: Introduction of New route of registration for medicine via Company Recognition
Regulatory Notification: Amendment of Interim guidelines for regulating face masks (medical grade) to facilitate availability of medical grade face mask in Bhutan
Regulatory Notification: Sample exemption acceptance of dossiers in soft copy for the purpose of registration during pandemic
Regulatory Notification on Bioequivalence and Biowaiver Requirements for Generic Drugs
Regulatory Notification on Sale and Distribution of Health Supplement Products
Regulatory Notification on Import of Health Supplements for Personal Use
Regulatory Notification on Requirement of Import Authorization for medical syringes
Regulatory Notification on Regulation of Medical Masks
Regulatory Notification on Emergency Use Authorization procedure and conditions for Deployment of COVID-19 Vaccines
Notification DRA/D1/11-NS/20-21/168 Exemption from the requirement o Registration of Chemicals
Notification 19/DRA/D4b/12-NTF/19-20/1386 on Hand Sanitizers
Notification DRA/DC/Notifications/2019-20/1298 for importing hand sanitizer
Notification DRA/D4b/12-NTF/19-20/1207 for personal protective equipment and products
Revocation of suspension notification of Ranitidine
Regulatory Notification on H.pylori kits
Ranitidine - Potential Contamination with N-Nitrosodimethylamine
Regulatory Notification on Health Supplement: 19/DRA/DC/Notification/2018-19/117
Regulatory Notification on Health Supplement: 19/DRA/DC/Notification/2018-19/983
Regulatory Notification on Health Supplements: 19/DRA/DC/Notification/2018-19/984
Notification to remind the general public to refrain from purchasing medicines from unauthorized sources
Reminder notification on collection of pharmaceutical wastes.
Notification on collection of pharmaceutical wastes.
Notification on prescribing or dispensing medicines beyond the approved indication
Sale and Distribution of Health supplements and Controlled Drugs
Regulatory Notification on Fixed Dose Combinations (FDCs)
New Procedure for Import Authorization
CME Workshop with Competent Persons of Retail Pharmacies, Wholesale & clinics
Notification on commencement and acceptance of TTI test kits dossiers for registration
Notification on requirement of Orien products for DRA approval
Notification on collection of Pharmaceutical waste
Public Notification on the use of Oxy-99
Public notification on skin creams and ointments containing steroids
Notification on reduction in number of product samples requested during submission of dossiers
Notification on the change of Application fee for Product dossier assessment
Need for Medical Certification
Notification on the change in validity of the authorizations issued by Drug Regulatory Auditory
Conditions and requirement for product registration through multinational companies and Expedited Registration Process
Notification regarding the sale of Prescription Only Medicines (POM)
Notification to the Market Authorization Holders
Notification on the changes made in BMRR 2012
Notification For Pharmacy Competency Course
Pharmaceutical Waste Notification 09/10/2014
Pharmaceutical Waste Notification 09/10/2014