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morning of August 26, the newly revised Drug Administration Law of the People's Republic of China was voted on by the 12th session of the Standing Committee of the 13th National People's Congress. The revised Drug Administration Law, with a total of 12 chapters and 155 articles, increases the penalties for drug violations.
This Law shall apply to the development, production, operation, use and supervision and management of pharmaceuticals within the territory of the People's Republic of China.
The law will come into force on 1 December 2019.
The newly revised Drug Administration Law of the People's Republic of China redefines what is a counterfeit drug. Article 98 clearly stipulates that counterfeit drugs include: drugs containing contents that do not conform to the contents stipulated in the National Drug Standards, drugs that are counterfeited as drugs with non-drugs or counterfeited as such drugs with other kinds of drugs, and drugs that have gone bad, and drugs marked as adaptive or functionally treated beyond the prescribed scope.
Inferior drugs include: drugs with contents that do not meet the national drug standards, contaminated drugs, drugs that do not indicate or change the validity period, drugs that do not indicate or change the batch number of the product, drugs that exceed the validity period, drugs that add preservatives and accessories without authorization, and other drugs that do not meet the drug standards.It is prohibited to produce or import drugs without obtaining proof of drug approval documents, and to produce drugs using raw materials, packaging materials and containers that have not been reviewed and approved in accordance with the provisions.
Article 124 of the newly amended Drug Administration Law of the People's Republic of China also makes it clear that the sale and use of certain drugs is liable under certain circumstances.
These include: the production and import of drugs without obtaining the certificate of drug approval, the production of drugs using raw materials approved without examination and approval, etc., if the selling or using unit uses the above-mentioned drugs in violation of the provisions of the previous paragraph, the legal representative of the drug-using unit, the principal person in charge, the person in charge directly responsible and other responsible personnel shall also revoke the practising certificate.
If a small number of drugs that have been legally listed abroad are imported without approval, if the circumstances are less serious, they may be reduced or exempted from punishment according to law.
(People's Daily)