Annex I. Legal Definitions of Medicines from the Quality Perspective-by country
p. 76-79
Texte intégral
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Category/country |
WHO |
Cambodia |
Lao PDR |
|
Name of law in year of enactment |
The 1996 Law on the Management of Pharmaceuticals |
Law on Drugs and Medical Products promulgated in 2000 |
|
|
Substandard |
Substandard medicines are products of which the composition and ingredients do not meet the correct scientific specifications and that are consequently ineffective and often dangerous to the patient. Substandard products may occur as a result of negligence, human error, insufficient human and financial resources or counterfeiting. |
A substandard drug is defined as a registered product of which the specifications are out of defined pharmacopoeias or accepted standards. |
A substandard drug is termed in this law as a “non-standard” drug, and is defined as any modern or traditional medicine, the composition of which is inconsistent with the drug’s registered formula. |
1This Annex provides brief descriptions of legal definitions related to medicine quality, with special focus on substandard and counterfeit medicines, in the five countries—Cambodia, China, Lao PDR, Thailand and Vietnam.
|
Thailand |
Vietnam |
Yunnan of China |
|
Drug Act of 1967 (BE 2510) |
Pharmaceutical Law was adopted in 2005 |
The Drug Administration Law of the People’s Republic of China, revised in 2001 |
|
A sub-standard drug as a drug: |
A substandard drug as a drug that has failed to meet the quality standards registered with the competent authorities. |
Any drug with content not up to the national drug standards is a substandard drug. In addition, the law specifies that any drug shall be treated as a substandard drug in any of the following cases: |
2 ANNEX I - Legal Definitions of Medicines from the Quality Perspective-by country
|
Category/country |
WHO |
Cambodia |
Lao PDR |
|
Counterfeit |
A counterfeit medicine is one that is “deliberately and fraudulently mislabelled with respect to identity and/or sources.” Counterfeiting can apply to both branded and generic products. These products may contain correct ingredients or wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging. (WHO 2003) |
as a drug: |
as any modern or traditional medicine that is a fake or is an imitation of a drug that is produced, distributed and legally registered |
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Thailand |
Vietnam |
Yunnan of China |
|
The definition of counterfeit or fake drug is clearly specified in the law (Article 73) as any drug or substance: |
A counterfeit drug is a product deliberately and fraudulently made in drug forms, including the followings: |
A counterfeit medicine is considered as a drug in any of the following cases: |
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