1. The labels of narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, drugs for external use and over-the-counter drugs must bear the prescribed marks. (drug administration law)
OTC labels, instructions for use, inner packaging and outer packaging must be printed with OTC proprietary logo (integrated printing, upper right corner). Red: Class A; Green: Class B, the guiding sign of enterprises. (regulations on the management of proprietary labels of over-the-counter drugs)
2. The minimum outer packaging of vaccines included in the national immunization program supplied by vaccine production enterprises and wholesale enterprises is prominently marked with the word "free" and the special label of "immunization program" specified by the health administrative department of the State Council. (Regulations on the Administration of Vaccine Circulation and Vaccination)
3. Labeling of Internet websites:
(1) The homepage of enterprises providing Internet drug trading services is marked with the qualification certificate number of Internet drug trading service institutions. (Interim Provisions on the Examination and Approval of Internet Drug Trading Services)
(2) Websites providing Internet drug information services shall mark the certificate number of the Qualification Certificate for Internet Drug Information Services in a prominent position on the homepage of their websites. (Measures for the Administration of Drug Information Services on the Internet)
4. Unilateral preparations made from medicinal materials and their decoction pieces under the administration of toxic drugs for medical use must be marked with the label of toxic drugs for medical use.
5. Requirements for external drug labeling:
A The word "external" is marked in the background color of the red box
B It should be printed in color;
C in the drug label can be printed in monochrome;
D in the instruction manual needs to be marked with external drug labeling; it is stipulated in the national standard that it can only be used for external use, and it is not allowed to be taken orally, injected, dripped or inhaled. Liquid, semi-solid or solid traditional Chinese medicine and natural medicine
E which are only used on body surface or some specific mucous membrane parts need not be marked with external drug label: traditional Chinese medicine and natural medicine which can be taken orally and used externally
6. Summary of labeling position:
upper right corner:
A. OTC proprietary label is in the upper right corner of label, instruction manual, inner packaging and outer packaging. (Provisions on the Administration of Unique Labels of Over-the-counter Drugs)
B. For emergency prescriptions, mark "Emergency" (Prescription Management Measures, P129)
C. For pediatric prescriptions, mark "Pediatric" (Prescription Management Measures, P129)
D. Anesthesia and Essence I, and mark "Anesthesia" and Essence I "in the upper right corner. (P223) The special requirements for prescription adjustment and decoction of Chinese herbal pieces are indicated in the upper right of the medicine (Prescription Management Measures, Article 6)
The upper left corner: the date of approval and modification of the drug instructions, which is below the approval date, and written line by line in chronological order (note that Chinese medicine, natural medicine, chemical medicine and biological medicine are slightly different, and the date is modified several times, Only for the last time)
Above the drug instructions: "Please read the instructions carefully and use them under the guidance of a doctor" (P223)
7. Color summary:
White: ordinary and refined prescription printing paper
Light yellow: emergency prescription printing paper
Yellow: drug wholesale and retail chain drug warehouses (areas) and returned drugs. Guiding signs of enterprises dealing in over-the-counter drugs, qualified drug warehouses (districts) of drug wholesale and retail chains, drug warehouses (districts) of zero-goods weighing and taking, and drug warehouses (districts) to be sent
Pale red: paper for anesthesia and precision printing
Red: unqualified drug warehouses (districts) of drug wholesale and retail chains
8. Contents of relevant symbol formats: < X drug serial number H(Z)+4-digit year number +4-digit serial number
(2) drug approval number: 8 digits, national medicine standard word H(Z, s, J)+4-digit year number +4-digit serial number (171 articles)
(3) import drug registration certificate: 8 digits, H(Z) H(Z, S)C+4-digit year number +4-digit serial number (p155,171)
(5) new drug certificate: 8 digits, Chinese medicine certificate H(Z, S)+4-digit year number +4-digit serial number (p155,171)
(6) drug advertisement. (2) valid until XXXX, XX month, XX day; (3) valid until XXXX.XX.；; (4) valid until xxxx/xx/xx; (The year is four digits, and the monthly and daily figures are two digits) (23)
(8) National drug code: the number * * * is 14 digits, which is divided into standard code, supervision code and classification code. Standard code (the first two digits are the country code of the drug, and the third digit is the drug category code "9", which represents the drug; 4-13 is the standard code (4-8 is the identification code of pharmaceutical enterprises; 9-13 for drug product identification); The last digit is the check code
Note: (1) What is the difference between imported drugs and domestic drugs? Whether it has the production approval of the State Food and Drug Administration shall prevail, that is, the varieties of national medicine with quasi-brand names are treated as domestic drugs, and the products of domestic packaging of imported drugs are treated as domestic drugs. Imported drugs should hold a legal registration certificate for imported drugs.
(2) Sub-packaging of imported drugs: Sub-packaging of imported drugs means that the final preparation process of drugs has been completed overseas, and the specifications of large packaging have been changed to small packaging specifications in China, or the drugs that have been internally packaged are externally packaged, with instructions and labels attached. (96) Note that large packages for domestic repackaging do not belong to repackaging of imported drugs.
9. summary of warning words or advice words and prescribed signs
warning words refer to warnings about serious adverse drug reactions and their potential safety problems, and may also include drug taboos, precautions, overdose and other matters that need to be paid special attention to by drug users.
① prescription drugs: sold, purchased and used according to the doctor's prescription! (Interim Provisions on the Administration of the Circulation of Prescription Drugs and OTC Drugs, Article 7)
② Class A and Class B OTC: Please read the instructions carefully and use them according to the instructions or purchase and use them under the guidance of pharmacists! (article 7)
③ medical institution preparation, which needs to be marked: this preparation is only used by this medical institution. (Measures for the Administration of Preparation Registration in Medical Institutions (Trial), Article 13)