Frequently asked questions about the packaging lab

Frequently asked questions about drug packaging, labels and instructions

1. For the varieties with less than twelve flavors in the prescription, the instructions should list all the ingredients in the prescription. For the varieties with more than twelve flavors in the prescription, the instructions can only list the main ingredients of ten to twelve flavors, and indicate the total number of flavors in the prescription. The item name should be changed to [main ingredients] accordingly

2. Outer label, large package. The central government and the government of the Hong Kong Special Administrative Region and people from all walks of life must list the label of the inner package of the manufacturer. Because of the size, except that [drug name], [Specification] and [product batch number] must be marked, and [manufacturer] can decide according to the size

3. Due to the size of the package, if [adverse reactions], [contraindications] and [precautions] cannot be indicated, the words "see the instructions for details" should be indicated

4. The text trademark used as a trade name without the approval of the State Drug Administration can be printed on the upper left or right corner of the packaging label, and its font shall not be larger than that of the common name

5. The drug name indicated in the drug instructions and labels shall be consistent with the drug approval certificate

6. A registered trademark used as a trade name without the approval of the State Food and drug administration can be printed on the upper left or right corner of the packaging label, and its font shall not be larger than the common name

7. The format and color of the packaging labels of the same enterprise and the same drug of the same specification and variety must be consistent, and different trademarks must not be used

8. If the same variety of the same enterprise has different specifications, the packaging and label of the smallest sales unit should be significantly different or the specification items should be clearly marked

9. The contents of [storage] should be based on quality standards, and the contents of instructions and packaging labels should be consistent

10. The term of validity of the package label is expressed as "valid until mm/DD/yyyy"; The term of validity in the specification is expressed as "month of validity" or "year of validity"

11. The item [packaging] in the manual should be completely noted, and the parts in the equipment have not been welded to indicate the packaging specification and packaging material

12. The unit of measurement cannot be omitted after the quantity in the package, label and instructions

13. The drug name, specification and product batch number shall be completely marked on the inner package label

14 [medication for pregnant women and lactating women] and [drug interaction] listed in the "format of chemical instructions" are indispensable and should be filled in truthfully. If there is no reliable experimental or literature basis, it should be noted that "not clear"

15. The [indications] or [functional indications] listed in the package, label and instructions shall be written according to the contents approved by the original national drug administration department, and shall not be added or modified without authorization

16. For drugs whose original local standards have been upgraded to national standards, the names have been changed due to reasons such as the original names do not conform to the naming principles, and the common names in the national standards should be used

17. Narcotic drugs, psychotropic drugs and other drugs under special management and drugs for external use must be printed with marks that conform to the regulations on their packages, labels and instructions

18. The manufacturer, production address, packaging specification, packaging material, packaging style and other contents of drugs shall be consistent with those approved by the State Food and drug administration

19. After the change of the packaging style of drugs is submitted to the supplementary application for approval, the originally filed packaging and label style should be stopped, and the varieties that have been produced can continue to circulate and use within the period of validity

20. For the varieties of Chinese patent medicine containing relevant Mutong in the national standard prescription, it is necessary to replace Mutong with Mutong within the specified time

21. For the drugs containing bezoar or its substitutes, the name of bezoar or its substitutes must be indicated under [ingredient] or [main ingredient] in the package label and instructions

22. The State Drug Administration publishes the sample manual of chemical drugs and the contents of the order of [main ingredients] in the manual of traditional Chinese medicine on the station, and all drug manufacturers should check it before printing the manual

23, [production batch number] is revised to [product batch number], [contraindication] is revised to [taboo], [function and indications] is revised to [function and indications], [usage and dosage] is revised to [usage and dosage]

24. In order to facilitate enterprises to handle drug packaging, labeling and pressurization devices, generally adopt hydraulic or pneumatic pressurization instructions for filing, the drug registration office of our Bureau specially provides packaging Labels and instructions the United States has developed shale oil on a large scale and China has implemented a special mailbox for the filing and examination of electric vehicles on a large scale

25. The filing materials are in duplicate, and the enterprise should carefully check the packaging labels and instructions