Medicines Act of the Kingdom of Bhutan 2003.
Country
Type of law
Legislation
Abstract
This Act is enacted to regulate the import, export, manufacture, sale, transportation and distribution of medicinal raw materials & products, and to safeguard the human and animal health to safeguard the human and animal health against harm resulting from the poor quality of medicinal products available in the Kingdom.
“Animal” mentioned in this Act means all ruminants and monogastric animals except man; any kind of mammals except man; any kind of four-footed beast which is not a mammal; fish, reptiles, crustaceans or other cold-blooded creatures of any species.
The Government shall constitute a Board known as Bhutan Medicines Board to advise the Government on technical matters (Sec.4). The Government shall also establish a Drug Regulatory Authority to be managed by an appropriate number of technical people with adequate qualifications and experience (Sec.10). All medicinal products, manufactured, sold, distributed and imported /exported from Bhutan shall be registered under the provisions of this Act (Sec. 16.2). The Ministry of Trade and Industry shall issue licenses for manufacture, import, export, and sale of medicinal products by retail or wholesale based on the approval of the Authority (Sec. 20.1). The manufacture of medicinal products shall be carried out under the supervision of a Competent Person approved for the purpose; The drugs to be manufactured shall be those which are registered and of standard quality (Sec.21). No person other than those authorised by the Board shall import, manufacture or sell any medicinal products, which are listed under the restricted and controlled items by the Board (Sec. 25).
The Act further makes provisions, inter alia, for: establishment of the Drug Testing Laboratory, drug inspectors, drug advertisement, storage and disposal of the expired medicines offences and penalties.
“Animal” mentioned in this Act means all ruminants and monogastric animals except man; any kind of mammals except man; any kind of four-footed beast which is not a mammal; fish, reptiles, crustaceans or other cold-blooded creatures of any species.
The Government shall constitute a Board known as Bhutan Medicines Board to advise the Government on technical matters (Sec.4). The Government shall also establish a Drug Regulatory Authority to be managed by an appropriate number of technical people with adequate qualifications and experience (Sec.10). All medicinal products, manufactured, sold, distributed and imported /exported from Bhutan shall be registered under the provisions of this Act (Sec. 16.2). The Ministry of Trade and Industry shall issue licenses for manufacture, import, export, and sale of medicinal products by retail or wholesale based on the approval of the Authority (Sec. 20.1). The manufacture of medicinal products shall be carried out under the supervision of a Competent Person approved for the purpose; The drugs to be manufactured shall be those which are registered and of standard quality (Sec.21). No person other than those authorised by the Board shall import, manufacture or sell any medicinal products, which are listed under the restricted and controlled items by the Board (Sec. 25).
The Act further makes provisions, inter alia, for: establishment of the Drug Testing Laboratory, drug inspectors, drug advertisement, storage and disposal of the expired medicines offences and penalties.
Attached files
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Long title of text
An Act to regulate the import, export, manufacture, sale, transportation and distribution of medicinal raw materials & products and for other matters connected therewith.
Date of text
Repealed
No
Source language
English
Legislation Amendment
No
Implemented by