2. Label of Chinese herbal pieces: product name, specification, place of origin, manufacturer, product batch number and production date. Chinese herbal pieces subject to approval number management must be marked with drug approval number. (Note: period of validity) (Articles P67 and 45 of the Regulations for the Implementation of the Drug Administration Law)
3. Labels or instructions
The Drug Administration Law stipulates: generic name, ingredients, specifications, manufacturer, approval number, product batch number, production date, expiration date, indications or functional indications, usage, dosage, contraindications, adverse reactions and precautions. (Articles 56 and 54 of the Drug Administration Law)
4. Internal label of drugs: generic name, indications or functional indications, specifications, usage and dosage, production date, product batch number, expiration date, manufacturer, etc. Because the package size is too small, the internal label should be marked with at least P220, 17 items such as generic name, specification, product batch number and expiration date.
External label of drugs: generic name, composition, nature, indications or functional indications, specifications, usage and dosage, adverse reactions, contraindications, precautions, storage, production date, product batch number, expiration date, approval number, manufacturer, etc. P220, 18
5. Packaging label for transportation and storage: generic name, specification, storage, production date, product batch number, expiration date, approval number and manufacturer of the drug. According to the need, the number of packages, transportation precautions or other signs can be marked. P220, 19
Comparison of transportation, storage, packaging and API label contents (P220,19,20)
①? Specifications? It is marked in the labels of transportation, storage and packaging, but not in the labels of APIs.
②? Professional standards? Not on the labels of transportation, storage and packaging, but on the labels of raw materials.
(3) What are the labels for transportation, storage and packaging? Generic name of drug? ; What is the label of the API? Drug name? .
6. API label: drug name, storage, production date, product batch number, expiration date, implementation standard, approval number, manufacturer, and also need to indicate packaging quantity and transportation precautions.