How to file a Chinese medicine agreement prescription for prescription drug filing

Chapter V of the Drug Administration Law that took effect on December 1, 2019?

Chapter V Drug Operation

Article 51 Engaged in pharmaceutical wholesale activities shall be approved by the drug supervision and management department of the people's government of the province, autonomous region, or municipality directly under the central government where it is located, and obtain a license for the operation of drugs. Engaged in pharmaceutical retail activities, shall be approved by the local people's government at or above the county level, drug supervision and management department, to obtain a drug license. Without a drug license, shall not operate drugs.

The drug license shall indicate the validity period and scope of business, the expiration of the re-examination of the license.

Drug supervision and management departments to implement the drug license, in addition to the conditions set out in Article 52 of this Law, should also follow the principle of facilitating the public purchase of drugs.

Article 52 to engage in pharmaceutical business activities shall have the following conditions:

(a) a pharmacist or other pharmacy technicians certified in accordance with the law;

(b) with the management of pharmaceutical products suitable for the business premises, equipment, warehousing facilities and sanitation;

(c) with the management of pharmaceutical products compatible with the quality management organizations or personnel;

(d) have regulations to ensure the quality of drugs, and in line with the State Council drug supervision and management department in accordance with the requirements of this Law formulated by the quality management standard of drug business.

Interpretation: emphasizes the need to engage in manufacturing activities in line with GSP requirements.

Article 53 of the drug business activities, should comply with the drug business quality management standards, establish and improve the drug business quality management system, to ensure that the whole process of drug business continues to meet the statutory requirements.

The state encourages and guides drug retail chain operations. The headquarters of enterprises engaged in retail chain operation of drugs shall establish a unified quality management system and fulfill the management responsibility for the business activities of the retail enterprises under them.

The legal representatives and principals of pharmaceutical enterprises are fully responsible for the pharmaceutical business activities of their enterprises.

Interpretation: GSP certification is no longer required! Establish and improve the quality management system of drug business, to encourage and guide the drug retail chain operation.

Article 54 of the State of the implementation of prescription drugs and non-prescription drugs classification and management system. Specific measures shall be formulated by the drug supervision and management department of the State Council in conjunction with the competent health department of the State Council.

Article 55 The holder of a listed drug license, drug manufacturers, drug business enterprises and medical institutions shall purchase drugs from the holder of a listed drug license or from an enterprise qualified to manufacture or operate drugs; however, the purchase of Chinese herbal medicines that have not been subject to approval and management is excluded.

Article 56 of the drug business enterprises to purchase drugs, shall establish and implement the purchase inspection and acceptance system, inspection of drug certificates and other identification; does not meet the prescribed requirements, shall not be purchased and sold.

Article 57 of the drug business enterprises purchase and sale of drugs, there should be true and complete purchase and sale records. Purchase and sale records should indicate the generic name of the drug, dosage form, specifications, product lot number, expiration date, marketing license holder, manufacturer, purchase and sale of units, purchase and sale of quantities, purchase and sale of prices, purchase and sale of the date and the State Council drug supervision and management department of the provisions of the other content.

Article 58 of the drug business enterprises should be accurate retail drugs, and correctly explain the usage, dosage and precautions; prescription allocation should be checked, the drugs listed on the prescription shall not be changed without authorization or substitution. There are contraindications or excessive dosage of prescriptions, should be refused to deploy; if necessary, by the prescribing physician to correct or re-signature, can be deployed.

Pharmaceutical companies selling Chinese herbal medicines, should be labeled with the place of origin.

According to law, the pharmacist or other pharmacy technicians who have been recognized by the qualification is responsible for the enterprise's drug management, prescription review and dispensing, rational use of medication guidance.

Article 59 of the drug business enterprises shall formulate and implement the drug storage system, to take the necessary refrigeration, anti-freezing, moisture-proof, insect-proof, rodent-proof and other measures to ensure the quality of drugs.

The entry and exit of drugs should be implemented inspection system.

Article 60 of the urban and rural fairs and trade markets can sell Chinese herbal medicines, except as otherwise provided by the State Council.

Article 61 of the drug listing license holder, drug business enterprises through the network sales of drugs, shall comply with the relevant provisions of this law drug business. Specific management measures shall be formulated by the drug supervision and administration department of the State Council in conjunction with the competent health department of the State Council and other departments.

Vaccines, blood products, narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, drug-type easy-to-use chemicals, and other drugs under special management by the state shall not be sold on the network.

Article 62 of the third-party platform providers of pharmaceutical network transactions shall, in accordance with the provisions of the State Council Drug Administration, to the local provincial, autonomous regions and municipalities directly under the Central People's Government Drug Administration for the record.

The third-party platform provider shall, in accordance with the law, apply for access to the platform business of drug listing license holders, the qualifications of drug business enterprises, etc., to audit, to ensure that it meets the statutory requirements, and the occurrence of the platform of the drug business behavior management.

The third-party platform provider found into the platform operation of drug listing license holders, drug business enterprises in violation of the provisions of this Law, shall promptly stop and immediately report to the local county-level people's government drug supervision and management department; found that serious violations of the law, it should immediately stop to provide network trading platform services.

Is the Specialty Drug Filing Form electronic?

It is electronic.

When filing, insured patients should submit the following information to the designated medical institutions for special drugs:

1. Application form for special drug treatment (filing/planning) of basic medical insurance;

2. Documents such as social security card, Xi'an medical insurance card and ID card of insured persons;

3. Information on medical records: pathology diagnosis, genetic testing and mandatory tests in the limited scope of special drugs, imaging reports, medical records, medical records, and other documents. Medical records: Pathological diagnosis, genetic testing and compulsory testing within the limited scope of special drugs, imaging reports, medical records, diagnosis and other relevant medical confirmations that can prove compliance with the indications for the use of drugs. The insured patient submits the above materials to the medical insurance office of the designated medical institution for special drugs, and the medical insurance office of the hospital verifies the completeness of the insured patient's declaration materials for special drugs. The physician in charge of special drugs will formulate a medication plan for eligible insured patients, and the medical insurance office of the hospital designated for special drugs will operate the data in the system on the contents filled in by the physician in charge of special drugs, so that the filing of special drugs will be completed.

After the completion of the filing of special drugs, insured patients need to be prescribed in the special drug designated medical institutions, medical insurance office audit confirmation, in accordance with the settlement process of special drugs uploaded medication plan, the patient can voluntarily choose to settle in the special drug designated medical institutions or special drugs designated retail pharmacies.

In addition, if the insured patients are required to use special drugs for treatment by drug manufacturers or charitable organizations such as foundations and charitable associations, the medical insurance fund will no longer pay for the special drug costs during the period of gratuitous supply of drugs.

Drugs to resume production declaration information?

I. Process consistency

Because of the long absence of production, in order to verify the consistency of the process after resumption of production and the original process, the applicant should provide the original registration approvals, re-registration approvals, as well as supplemental applications for approvals and the necessary attachments, such as: the prescription process of the drug registration declaration, re-registration of the drug prescription process filing information sheet and other key process information content. It should also provide the current process protocols after the completion of process validation.

Second, involving changes

Resumption of production in the process of changes involved, the enterprise should be in accordance with the "listed chemical drugs pharmacy change research technical guidelines (for trial implementation)", "listed Chinese medicine pharmacy change research technical guidelines (for trial implementation)" and other changes in the guiding principles of the changes involved in the categorization, and to carry out the corresponding changes in the quality of drugs after the study. At the same time, it should comply with the relevant requirements of the Measures for the Administration of Drug Registration and the Implementing Rules for the Management of Post-market Changes of Drugs in Hubei Province (for trial implementation).

Three, process validation issues

The applicant should be based on the original registered process to prepare the corresponding draft process protocols, according to the draft process protocols to prepare process validation program, and ultimately according to the process validation program for three consecutive batches of commercial scale process validation and the formation of process validation report, in order to determine the detailed process parameters. The process validation of the three batches of samples for testing, should be in line with the provisions of the quality standard.

How many years are prescriptions kept in a pharmaceutical retailer?

1, how long is the preservation period of ordinary prescriptions

1, how long is the preservation period of ordinary prescriptions ordinary prescriptions, emergency prescriptions, pediatric prescriptions preservation period of one year, the preservation period of toxic drugs for medical use, the second category of psychotropic drugs prescriptions preservation period of two years, narcotic drugs and the first category of psychotropic drugs prescriptions preservation period of three years. Prescription retention period expires, the approval of the principal medical institutions, registration for the record, before destruction. Second, the rules for writing prescriptions is how (a) the patient's general condition, clinical diagnosis is filled out clearly, completely, and consistent with the medical records. (B) each prescription is limited to a patient's medication. (C) the handwriting is clear, not altered; if you need to modify, you should sign the modification and indicate the date of modification.

How does an intermediate practitioner get the right to prescribe?

The prescribing right of physicians is divided into three kinds: prescribing right of general drugs, prescribing right of antibacterial drugs, and prescribing right of essential drugs.

1. The prescribing right for general drugs is granted directly by the registered/recorded medical institutions.

2. Antimicrobial drug prescribing rights are granted:

(1) above the second level of medical institutions by the institutional training and assessment of the grant; other medical institutions by the county-level health administrative department of the training and assessment of the grant;

(2) according to the different titles of doctors, respectively, to limit their use of authority (senior title to grant the right to prescribe special-use-grade antimicrobial drugs; intermediate and above title). (senior title is granted the right to prescribe restricted use-grade antimicrobial drugs; intermediate and above title is granted the right to prescribe non-restricted use-grade antimicrobial drugs).

3. Acquisition of the right to prescribe narcotic drugs:

Medical institutions in accordance with the relevant provisions of the institution, the licensed physician for the use of narcotic drugs and psychotropic substances and the standardized management of knowledge and training. Licensed physicians after passing the examination to obtain narcotic drugs and psychotropic substances of the first class prescription authority.