药品包装说明书-en

Article 8 Pharmaceutical packages include inner packages and outer packages.

(I) Inner packages refer to packages in immediate contact with drug products (e.g. ampoules, injection bottles, aluminium foils, etc.). Inner packages shall be able to ensure quality of drug products in manufacture, transportation, storage and use and be convenient to use for medical purposes.

For changes of inner package materials and containers (pharmaceutical container closure systems) of drug products, stability testing shall be performed depending on material of the used container closure system to investigate compatibility of the container closure system with the pharmaceutical product.

(II) Outer packages refer to packages other than inner packages and include middle packages and large packages from the inside to the outside. Rugged packages shall be selected depending on properties of drug products to ensure quality of products in transportation, storage and use.

Article 9 Pharmaceutical labels include inner package labels and outer package labels.

(I) Contents of inner package labels and outer package labels shall be restricted to those specified in the pharmaceutical directions approved by State Food and Drug Administration; literal expressions shall correspond to the directions.

(II) The inner package label shall, depending on the size, address, as far as possible, the drug name, indications or functions, dosage and administration, strength, manufacturing date, lot number, shelf life, manufacturer, etc. The drug name, strength and lot number are items that must be covered.

(III) The middle package label shall address the drug name, main ingredients, description, indications or functions, dosage and administration, contraindications, strength, storage, manufacturing date, lot number, shelf life, approval number, manufacturer, etc.

(IV) The large package label shall address the drug name, strength, storage, manufacturing date, lot number, shelf life, approval number, manufacturer and other necessary information beyond the description such as quantity in the package, announcements about transportation or other marks. (V) The shelf life on the labels shall be expressed as: Valid to: (year) (month)

(VI) Where all adverse reactions, contraindications and announcements cannot be indicated in the middle package label due to size restriction, words “See the description for details”shall be indicated.

Article 10 For packages of drug substances, paragraph (I) of Article 8 shall be referred to for implementation and labels shall be made as per provisions for large package labels of drug products.

Article 11 The package of each minimum marketing unit of drug products shall be printed or pasted with the label according to the requirements and attached with the direction.

Article 12 Pharmaceutical directions shall cover basic scientific information about the drug products such as safety and efficacy.

Pharmaceutical directions shall address the following items: drug names (generic name, English name, Chinese pinyin, chemical name), chemical formula, molecular weight, structure formulae (ingredients shall be specified for compound products and biological products) ), description,