Bhutan Medicines Rules and Regulation 2019.
Country
Type of law
Regulation
Abstract
This Bhutan Medicines Rules and Regulation 2019 is enacted in accordance with the Medicines Act of the Kingdom of Bhutan 2003. The objective of this Regulation shall be to: (1) regulate all medicinal products to ensure quality, safety and efficacy; (2) promote access and availability of medicinal products; and (3) promote transparency and efficiency in the services provided by the Drug Regulatory Authority.
The Text of the Bhutan Medicines Rules and Regulation 2019 consists of 288 Sections divided into 17 Chapters. Chapter II provides for the functions of the Bhutan Medicines Board, and functions and procedure of the Drugs Technical Advisory Committee. Chapter III gives the details on the powers and functions of the Drug Regulatory Authority, which mainly include: (1) regulate manufacture, import and export, storage, sales, dispensing and distribution of medicinal product, health supplements and feed supplements; (2) register medicinal product for manufacture, import, export, stocking, sales and distribution; (3) register Competent Person for manufacture, sale, distribution and dispensing of medicinal products; (4) develop standards, guidelines and conditions required for implementation of this Regulation; (5) develop and prescribe the formats for application, certification and Technical Authorizations for the purpose of carrying out functions under this Regulation; (6) maintain national registry of medicinal products and Competent Person; etc. Chapter IV deals with the functions of the Drug Testing Laboratory, and the Government Analyst.
According to the Chapter V Clinical Trial Oversight, the Authority shall maintain a registry of approved clinical trial and shall make it available for the public (Sec.17). All stakeholders shall comply with the Good Clinical Practice Guidelines prescribed by the Authority (Sec.18). Chapter VI and VII provid for the Technical Authorization for Manufacture, Sale and Distribution. The Technical Authorization for Manufacture shall be a prerequisite for obtaining a license from the Ministry of Economic Affairs for manufacturing any medicinal products. Any individual or firm shall obtain approval from the Authority prior to sale and distribution of medicinal products. According to Chapter VIII Competent Person, the Authority shall register the key personnel involved in manufacturing as Competent Person. Chapter IX provides for marketing authorization of medicinal products. Any manufacturer both within or outside the country or firm authorized for the purpose of sale and distribution or government agencies shall be eligible to apply for registration of medicinal product.
In addition, the Bhutan Medicines Rules and Regulation 2019 makes provisions, inter alia, for: import and export authorization, inspection, surveillance of medicinal products, advertisement of medicinal products, lot release of vaccines and biologicals, offences and penalties.
The Text of the Bhutan Medicines Rules and Regulation 2019 consists of 288 Sections divided into 17 Chapters. Chapter II provides for the functions of the Bhutan Medicines Board, and functions and procedure of the Drugs Technical Advisory Committee. Chapter III gives the details on the powers and functions of the Drug Regulatory Authority, which mainly include: (1) regulate manufacture, import and export, storage, sales, dispensing and distribution of medicinal product, health supplements and feed supplements; (2) register medicinal product for manufacture, import, export, stocking, sales and distribution; (3) register Competent Person for manufacture, sale, distribution and dispensing of medicinal products; (4) develop standards, guidelines and conditions required for implementation of this Regulation; (5) develop and prescribe the formats for application, certification and Technical Authorizations for the purpose of carrying out functions under this Regulation; (6) maintain national registry of medicinal products and Competent Person; etc. Chapter IV deals with the functions of the Drug Testing Laboratory, and the Government Analyst.
According to the Chapter V Clinical Trial Oversight, the Authority shall maintain a registry of approved clinical trial and shall make it available for the public (Sec.17). All stakeholders shall comply with the Good Clinical Practice Guidelines prescribed by the Authority (Sec.18). Chapter VI and VII provid for the Technical Authorization for Manufacture, Sale and Distribution. The Technical Authorization for Manufacture shall be a prerequisite for obtaining a license from the Ministry of Economic Affairs for manufacturing any medicinal products. Any individual or firm shall obtain approval from the Authority prior to sale and distribution of medicinal products. According to Chapter VIII Competent Person, the Authority shall register the key personnel involved in manufacturing as Competent Person. Chapter IX provides for marketing authorization of medicinal products. Any manufacturer both within or outside the country or firm authorized for the purpose of sale and distribution or government agencies shall be eligible to apply for registration of medicinal product.
In addition, the Bhutan Medicines Rules and Regulation 2019 makes provisions, inter alia, for: import and export authorization, inspection, surveillance of medicinal products, advertisement of medicinal products, lot release of vaccines and biologicals, offences and penalties.
Attached files
Web site
Date of text
Repealed
No
Source language
English
Legislation Amendment
No
Implements