1, the concept of drugs: drugs refer to substances used to prevent, treat and diagnose human diseases, purposefully regulate human physiological functions, and specify indications or functional indications, indications, usage and dosage.
2. Drug category:
Business scope of drug business license use
Including Chinese herbal medicines, Chinese herbal pieces, Chinese patent medicines, chemical raw materials and their preparations, antibiotic raw materials and their preparations, biochemical drugs, radioactive drugs, serum, vaccines, blood products and diagnostic drugs.
Refined and released drugs with special management, such as poisonous hemp, can only be operated with the relevant approval documents of the drug supervision department, otherwise it will be regarded as beyond the scope of operation.
3. Formula of medicine
The dosage forms of drugs mainly include: injections, tablets, capsules, pills, syrups and granules.
Preparation, powder, oral liquid, suspension, emulsion, tincture, suppository, ointment, eye ointment,
Eye drops, air (powder) mist and spray, film, ear drops, nose drops, lotion, liniment,
Gel, plaster, transdermal patch, etc.
4. Drug specifications
The specification of a drug refers to the pharmaceutical ingredients contained in a pharmaceutical preparation unit.
Quantity. Drug specifications are usually expressed by content, volume, concentration and quality (weight).
Quantity), quantity, etc. Or a combination of several ways.
5. The approval number of the drug
The drug approval number refers to the drug number approved by the state to produce drugs by pharmaceutical production enterprises, and is the name of the drug producer.
A sign of the legitimacy of production. The Drug Administration Law stipulates that the production of drugs "must be approved by the State Council Drug Administration.
The administrative department approved and issued a "drug approval number".
Drugs produced without approval number shall be treated as counterfeit drugs.
6. The US Food and Drug Administration basically completed the approval in 2003.
Unified serial number. At present, the unified format of drug approval number is:
Chinese medicine quasi-character+1 digit letter +8 digits.
Such as: National Medicine Zhunzi H20050089
Meaning of letters: H, Z, B, S, T, F, J.
H: chemistry z: Chinese patent medicine
B: health medicine s: biological products
F: pharmaceutical adjuvant T: in vitro chemical diagnostic reagent.
J: imported sub-packaged drugs
The approval number is valid for five years. Xinjiang completed local drugs in 2002. ※.
The document number was changed to quasi-Chinese name, and the quasi-Chinese name was re-injected on 20 10.
The number of the book and approval is consistent with the original change number.
6. Drug batch number
The production batch number of drugs generally refers to the homogeneous products obtained by the same batch of raw materials and the same processing equipment through the same processing.
Batch number is an important symbol of quality tracking.
7. Date of manufacture and expiry date of the drug
The production batch number of drugs is not necessarily expressed by the production time of drugs, so the packaging label of drugs should also indicate the production date of drugs.
The expiration date of a drug refers to the period when the drug is approved for use, that is, the quality of the drug can be guaranteed under certain storage conditions.
The expiration date of a drug is a sign related to the stability and safety of the drug, which must be marked in the drug instructions according to regulations. At present, the general method to indicate the expiration date on the drug packaging label is to use the expiration date to a certain year and month.