Article 49 prohibits the production and sale of inferior medicines.
The content of pharmaceutical ingredients does not comply with the national drug standards, as inferior drugs.
Drugs with one of the following circumstances shall be punished as substandard drugs:
(a) failure to indicate the expiration date or change the expiration date;
(b) failure to indicate or change the production lot number;
(c) exceeding the expiration date;
(d) unauthorized packaging materials and containers that are in direct contact with the drugs;
(e) Unauthorized addition of coloring agents, preservatives, spices, flavoring agents and excipients;
(vi) other non-compliance with the provisions of the drug standard.
Article 50 The name of the drug included in the national drug standard is the generic name of the drug. Has been used as a generic name of drugs, the name shall not be used as a pharmaceutical trademark.
Article 51 of the drug manufacturers, drug companies and medical institutions in direct contact with the staff of the drug, must be annual health checks. Those who suffer from infectious diseases or other diseases that may contaminate medicines shall not engage in work that directly contacts medicines.
Chapter VI Management of Drug Packaging
Article 52 Packaging materials and containers that are in direct contact with drugs must meet the requirements for medicinal use, and conform to the standards for safeguarding human health and safety, and shall be approved by the drug supervision and management department together with the approval of drugs.
Drug manufacturers shall not use unapproved packaging materials and containers that come into direct contact with drugs.
The unqualified packaging materials and containers in direct contact with medicines shall be ordered by the drug supervision and management department to stop using them.
Article 53 The packaging of medicines must be suitable for the requirements of the quality of medicines and convenient for storage, transportation and medical use.
Shipping Chinese herbal medicines must be packaged. On each package, the name, place of origin, date, and unit of dispatch must be indicated, and accompanied by a mark of satisfactory quality.
Article 54 The packaging of medicines must be printed or labeled with instructions in accordance with the provisions.
The label or instructions must indicate the generic name of the drug, ingredients, specifications, manufacturer, approval number, product batch number, date of manufacture, expiration date, indications or functions, usage, dosage, contraindications, adverse reactions and precautions.
The labels of narcotic drugs, psychotropic drugs, toxic drugs for medical use, radiopharmaceuticals, medicines for external use and over-the-counter medicines must bear the required symbols