Chapter 5 of the Drug Administration Law that took effect on December 1, 2019?
Chapter 5 Pharmaceutical Business
Article 51: To engage in pharmaceutical wholesale activities, one must obtain approval from the pharmaceutical regulatory department of the people’s government of the province, autonomous region, or municipality directly under the Central Government where the place is located, and obtain a pharmaceutical distribution license. . To engage in drug retail activities, one must obtain approval from the drug regulatory department of the local people's government at or above the county level and obtain a drug business license. Without a drug business license, no drug business is allowed.
The drug business license should indicate the validity period and business scope, and the license will be re-examined and issued upon expiration.
In addition to the conditions stipulated in Article 52 of this Law, the drug regulatory department shall also follow the principle of facilitating the public's purchase of drugs when implementing drug business licenses.
Article 52 Those engaged in pharmaceutical business activities must meet the following conditions:
(1) Have pharmacists or other pharmaceutical technicians who have been qualified in accordance with the law;
(2) Have business premises, equipment, storage facilities and sanitary environment suitable for the drugs being sold;
(3) Have quality management institutions or personnel suitable for the drugs being sold;
(4) Have rules and regulations to ensure drug quality, and comply with the requirements of the drug distribution quality management regulations formulated by the drug regulatory department of the State Council in accordance with this Law.
Interpretation: It is emphasized that production activities must comply with GSP requirements.
Article 53 Those engaged in pharmaceutical business activities shall abide by the pharmaceutical business quality management regulations, establish and improve the pharmaceutical business quality management system, and ensure that the entire pharmaceutical business process continues to comply with legal requirements.
The state encourages and guides pharmaceutical retail chain operations. Corporate headquarters engaged in pharmaceutical retail chain operations shall establish a unified quality management system and perform management responsibilities for the operating activities of its affiliated retail enterprises.
The legal representative and principal person in charge of a pharmaceutical operating enterprise shall be fully responsible for the pharmaceutical operating activities of the enterprise.
Interpretation: GSP certification is no longer required! Establish and improve the pharmaceutical operation quality management system, encourage and guide pharmaceutical retail chain operations.
Article 54: The state implements a classified management system for prescription drugs and non-prescription drugs. Specific measures shall be formulated by the drug regulatory department of the State Council in conjunction with the health authority of the State Council.
Article 55: Drug marketing license holders, drug manufacturing enterprises, drug operating enterprises and medical institutions shall purchase drugs from drug marketing license holders or enterprises with drug production and operation qualifications; However, this does not apply to the purchase of Chinese medicinal materials that have not been subject to approval management.
Article 56: When purchasing drugs, pharmaceutical operating enterprises shall establish and implement a purchasing inspection and acceptance system, and verify drug qualification certificates and other identifications; if they do not meet the prescribed requirements, they shall not be purchased or sold.
Article 57: Pharmaceutical business enterprises shall have true and complete purchase and sale records when purchasing and selling drugs. The purchase and sale records shall indicate the generic name, dosage form, specification, product batch number, validity period, marketing authorization holder, production enterprise, purchase and sale unit, purchase and sale quantity, purchase and sale price, purchase and sale date, and other contents specified by the drug regulatory department of the State Council.
Article 58: Drug retailing enterprises shall be accurate in retailing drugs, and correctly explain the usage, dosage and precautions; the prepared prescriptions shall be verified, and the drugs listed in the prescription shall not be changed or substituted without authorization. Prescriptions with incompatible or excessive dosages shall be refused to be dispensed; if necessary, they may be dispensed only after being corrected or re-signed by the prescribing physician.
Pharmaceutical business enterprises selling traditional Chinese medicinal materials must indicate the place of origin.
Pharmacists or other pharmaceutical technicians who have been qualified in accordance with the law are responsible for the company's drug management, prescription review and deployment, and guidance on rational drug use.
Article 59: Drug trading enterprises shall formulate and implement drug storage systems and take necessary measures such as refrigeration, anti-freeze, moisture-proof, insect-proof, and rodent-proof to ensure the quality of drugs.
An inspection system should be implemented for the entry and exit of medicines from the warehouse.
Article 60: Traditional Chinese medicinal materials may be sold in urban and rural fairs and trade markets, unless otherwise specified by the State Council.
Article 61 Drug marketing authorization holders and drug operating enterprises selling drugs through the Internet shall abide by the relevant provisions of this Law on drug operation. Specific management measures shall be formulated by the drug regulatory department of the State Council in conjunction with the health and health authorities of the State Council and other departments.
Vaccines, blood products, narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, pharmaceutical precursor chemicals and other drugs subject to special management by the country are not allowed to be sold online.
Article 62: Third-party platform providers for online drug transactions shall, in accordance with the provisions of the drug regulatory department of the State Council, register with the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government where they are located.
Third-party platform providers shall review the qualifications of drug marketing license holders and drug operating enterprises that apply to operate on the platform in accordance with the law to ensure that they comply with legal requirements, and conduct regulatory review of drug operations that occur on the platform. Behavior management.
If a third-party platform provider discovers that drug marketing license holders or drug operating enterprises operating on the platform have violated the provisions of this law, it shall promptly stop and immediately report to the drug regulatory department of the local county-level people's government. ; If serious violations of the law are discovered, the provision of online trading platform services should be immediately stopped.
Is the Special Drug Registration Form electronic?
It is electronic.
Insured patients must submit the following information to designated medical institutions for special drugs when filing:
1. Basic Medical Insurance Special Drug Treatment (Registration/Plan) Application Form;
2. Social security card, Xi'an medical insurance card, ID card and other documents of the insured person;
3. Medical records: pathological diagnosis, genetic testing and required items limited to special drugs, Imaging reports, medical records, diagnosis certificates and other relevant medical confirmation materials that can prove compliance with medication indications. Insured patients submit the above materials to the Medical Insurance Office of designated medical institutions for special drugs, and the medical insurance office of the hospital will check the completeness of the insured patients’ special drug application materials. The physician responsible for special drugs will formulate a medication plan for eligible insured patients, and the medical insurance office of the designated hospital for special drugs will perform data operations in the system on the relevant content filled in by the physician responsible for special drugs, so that the registration of special drugs is completed.
After the registration of special drugs is completed, insured patients need to issue prescriptions at designated medical institutions for special drugs. After review and confirmation by the Medical Insurance Office, the medication plan will be uploaded in accordance with the settlement process for special drugs. Patients can voluntarily choose to receive medical treatment at designated medical institutions for special drugs. Settlement by institutions or designated retail pharmacies for specialty drugs.
In addition, if the insured patient uses the special medicines provided by drug manufacturers or charitable organizations such as foundations and charity federations for free due to treatment needs, the medical insurance fund will no longer pay. .
Documents for drug production resumption?
1. Process consistency issues
Since production has not been carried out for a long time, in order to verify the consistency of the process after resuming production with the original process, the applicant should provide the original registration approval document and re-registration approval document As well as supplementary application approval documents and necessary attachments, such as: prescription process for drug registration application, drug re-registration prescription process filing information form and other key process information. At the same time, the current process procedures after completion of process verification should also be provided.
2. Issues involving changes
If changes are involved during the production resumption process, the company should follow the "Technical Guiding Principles for Research on Pharmaceutical Changes of Marketed Chemical Drugs (Trial)", Change guidelines such as the "Technical Guiding Principles for Research on Pharmaceutical Changes in Marketed Traditional Chinese Medicines (Trial)" classify the changes involved and conduct research on the quality of the drugs after the corresponding changes. At the same time, it should comply with the relevant requirements of the "Drug Registration Management Measures" and the "Hubei Province Drug Post-market Change Management Implementation Rules (Trial)".
3. Process verification issues
Applicants should prepare a corresponding draft process specification based on the original registered process, prepare a process verification plan based on the draft process specification, and finally conduct continuous testing according to the process verification plan. Three batches of commercial-scale process were validated and a process validation report was generated to determine detailed process parameters. Three batches of samples for process verification should be inspected and should meet the requirements of quality standards.
How many years do drug retail companies keep prescriptions?
1. How long is the shelf life of ordinary prescriptions?
1. How long is the shelf life of ordinary prescriptions? The shelf life of ordinary prescriptions, emergency prescriptions, and pediatric prescriptions is 1 year. Toxic drugs for medical use, etc. The retention period for prescriptions of Class II psychotropic drugs is 2 years, and the retention period for prescriptions of narcotic drugs and Class I psychotropic drugs is 3 years. After the prescription storage period expires, it can only be destroyed after approval and registration by the person in charge of the medical institution. 2. What are the rules for writing prescriptions? (1) The patient’s general condition and clinical diagnosis should be filled out clearly and completely, and consistent with the medical records. (2) Each prescription is limited to medication for one patient. (3) The handwriting must be clear and must not be altered; if modifications are required, signatures must be placed on the modifications and the date of modification must be noted.
How do you obtain the prescribing authority of a mid-level physician?
Doctors’ prescribing rights are divided into three types: general drug prescribing rights, antibacterial drug prescribing rights, and semen and anesthetic drug prescribing rights.
1. The right to prescribe general drugs is directly granted by registered/recorded medical institutions.
2. Obtaining the right to prescribe antibacterial drugs:
(1) Medical institutions above the second level shall be awarded by passing the training and assessment of the institution; other medical institutions shall be awarded by the county-level health administration department if they pass the training and assessment. Granted;
(2) Limit the use rights of doctors according to their different professional titles (senior professional titles grant the right to prescribe special-use antibacterial drugs; intermediate and above professional titles grant the right to prescribe restricted-use antibacterial drugs; junior and above The title confers the right to prescribe unrestricted-use antibacterial drugs).
3. Obtaining the right to prescribe narcotic drugs:
Medical institutions shall, in accordance with relevant regulations, conduct training on the use knowledge and standardized management of narcotic drugs and psychotropic drugs for their own practicing physicians. Practicing physicians shall obtain the right to prescribe narcotic drugs and Class I psychotropic drugs after passing the examination.