Definition of counterfeit drugs and inferior drugs

Legal analysis: the definition of counterfeit drugs is:

First, the ingredients contained in the drug are inconsistent with those stipulated in the national drug standards.

The second is to pass off non-drugs as drugs or pass off other drugs as drugs.

Three, one of the following circumstances, drugs shall be punished as counterfeit drugs. Where the use is prohibited by the drug supervision and administration department of the State Council, it must be approved according to this law, but it is produced or imported without approval, or it must be inspected according to this law and sold without inspection. There is deterioration or pollution, and the approval number must be obtained according to this law, but the approval number has not been obtained, and the raw materials without the approval number are produced. Indications or functional indications are beyond the prescribed scope.

Definition of inferior drug: the content of drug components does not meet the national drug standards. Drugs under any of the following circumstances shall be treated as inferior drugs:

First, the validity period is not marked or changed.

Second, the production batch number is not marked or changed.

Third, beyond the validity period.

Fourth, direct contact with packaging materials and windows of drugs is not allowed.

Legal basis: Drug Administration Law of People's Republic of China (PRC).

Article 48 The production (including preparation, the same below) and sale of counterfeit drugs are prohibited.

In any of the following circumstances, it is a counterfeit drug:

(a) the ingredients contained in the drug are inconsistent with the provisions of the national drug standards;

(2) passing off non-drugs as drugs or passing off other drugs as drugs.

Drugs under any of the following circumstances shall be treated as counterfeit drugs:

(a) prohibited by the drug supervision and administration department of the State Council;

(2) Producing, importing or selling without the approval of this Law;

(3) deterioration;

(4) being polluted;

(five) the use of raw materials that must obtain the approval number in accordance with this law, but have not obtained the approval number;

(six) the indications or functional indications are beyond the prescribed scope.

Article 49 The production and sale of inferior drugs are prohibited.

If the content of drug ingredients does not meet the national drug standards, it is inferior.

Drugs under any of the following circumstances shall be punished as inferior drugs:

(1) Failure to indicate the validity period or change the validity period;

(two) the production batch number is not marked or changed;

(three) beyond the validity period;

(4) The packaging materials and containers that come into direct contact with drugs are not approved;

(5) Adding colorants, preservatives, spices, correctants and auxiliary materials without authorization;

(six) other do not meet the requirements of drug standards.