1
According to the Measures for the Supervision and Administration of Drug Online Sales, drug online sellers should be pharmaceutical production enterprises, pharmaceutical wholesale enterprises and pharmaceutical retail chain enterprises that have obtained the qualifications for drug production and operation. So there is no online sales license. Next, the process of handling the license of pharmaceutical retail enterprises is introduced.
2
Log in to the district-level government service website where the enterprise as a legal person is registered.
3. In the department navigation bar, select the business acceptance department "District Market Supervision Bureau".
four
Select "drug supervision" in the business keywords accepted by this department.
five
In the specific drop-down business list, select "Pharmaceutical Products for Pharmaceutical Trading (Retail) Enterprises (Chain Stores and Monomer Drugstores)" and click "Online Handling" on the right.
6. In the jump business, check the conditions required to handle the business.
seven
In the declaration system, the relevant information registration and data uploading can be completed according to the instructions, and the corresponding application can be completed after submission.
How to negotiate the drug reimbursement process?
A: The National Medical Insurance Bureau and Ministry of Human Resources and Social Security organized experts to negotiate the access to the national medical insurance drug list according to procedures. The drugs successfully negotiated are highly recognized, newly marketed and of high clinical value, involving tumors, rare diseases, hepatitis, diabetes, multidrug-resistant tuberculosis, rheumatism immunity, cardiovascular and cerebrovascular diseases, digestion and so on 10. The national unified payment standard and some "expensive drugs" are provided at civilian prices. Shandong negotiation drugs (special drugs for serious diseases) are included in the payment of serious illness insurance, and the commercial insurance company will review and pay for them.
Consultation: How to negotiate drug reimbursement?
When the insured uses 103 kinds of national negotiated drugs managed by "dual channels" (including 16 kinds of Class B drugs managed by reference to negotiated drugs), the responsible doctor of the "Sanding" medical institution shall fill in the Yantai City Negotiated Drug Use Audit Form (hereinafter referred to as the Audit Form) according to the insured's medical needs and the limited payment scope stipulated in the national drug list, and after being audited and filed by the medical insurance department of the medical institution. Insured persons purchase and use drugs in designated medical institutions or "dual-channel" designated retail pharmacies with the Audit Form and the prescription of responsible doctors. The validity period of each drug filing is half a year. If the insured still needs to use the drug after the expiration of the validity period and meets the conditions of medical insurance payment, he may continue to apply; If the payment conditions are not met, the expenses shall be borne by the individual. The medical insurance fund will not pay the expenses incurred by the insured who is included in the charitable donation.
Outpatient medication for chronic diseases: according to the reimbursement policy related to chronic diseases. The insured person negotiates outpatient drug expenses in non-personal designated "Sanding" medical institutions and specialized drug retail pharmacies, and the individual pays the full amount to the designated medical institutions for reimbursement of chronic diseases. Follow-up will gradually open special drug retail pharmacies for direct settlement.
Outpatient Medication Security Mechanism Medication: When the insured employees use it in outpatient service, the part of the compliance drug fee paid by individuals according to the prescribed proportion will be paid by the medical insurance fund according to the proportion of 80%. When the insured residents use the outpatient service, the individual shall pay the compliance drug fee according to the prescribed proportion, and the first file and the second file shall be paid by the residents' medical insurance fund according to the proportion of 40% and 60% respectively. The expenses incurred by the insured in the outpatient service of "Sanding" medical institutions and specialized drug retail pharmacies will be reimbursed by medical institutions temporarily, and the designated specialized drug retail pharmacies will be gradually opened for direct settlement.
Insured persons who use negotiation drugs in hospitals shall be settled according to relevant hospitalization policies after being audited and put on record. During hospitalization, if the medical institution is short of medicine, the medical institution shall be responsible for merging the hospitalization expenses, which shall be settled together with the consent and registration of the medical insurance department of the hospital, and the "double channel" negotiation of drug expenses occurred in other "three-set" medical institutions and specialized drug retail pharmacies.
What does the drug filing price mean?
The drug record price is the drug price recorded by the drug regulatory authorities, which usually refers to the retail price.
Drug destruction filing process?
1, destroy the declaration
After the approval of the financial department, the unqualified drugs that have been confirmed to be expired and the damaged drugs and their packages that have been reported to be damaged shall be cleaned up regularly and destroyed centrally. Before centralized destruction, the quality control department shall supervise the warehouse management department to fill in the Declaration Form for Drug Destruction and attach the List of Abandoned Drugs. After the approval of the general manager, the two forms shall be reported to the Food and Drug Administration and the Tax Bureau. Without approval, it shall not be destroyed by itself.
2. Failure cycle
In order to clean up the warehouse in time, so as not to cause waste accumulation and occupy the site, waste drugs are destroyed at least once a year. During this period, when the Food and Drug Administration has a unified action requirement, it will implement it according to the unified deployment.
3. Destroy monitoring
Before the drugs are destroyed, they should be counted under the supervision of the quality control department to prevent the loss of unqualified drugs from causing adverse consequences such as safety accidents; Under the guidance and supervision of the Food and Drug Administration, the destruction treatment must consider preventing environmental pollution, and stay away from urban areas and densely populated areas, as well as the upper reaches of wind and water; Take effective measures such as mashing, burning and deep burial for destruction. The quality control department monitors the whole process from delivery to destruction.
4. Destroy records
In the process of destroying the above-mentioned waste drugs, the quality control department should supervise all links to accurately record and sign. The original documents reviewed and submitted for approval shall be submitted to the financial department for review; The quality control department is responsible for filing the documents and materials in duplicate within three days after the event, and the retention period is not less than three years.
What is the record number of drug supervision machinery production?
It is the record number of medical devices that are allowed to be produced, not the record number of drugs. Medical devices refer to instruments, equipment, appliances, in-vitro diagnostic reagents and calibrations, materials and other similar or related items directly or indirectly used in human body, including required computer software.
Medical instruments include medical equipment and medical consumables. Utility is mainly obtained by physical means, not by pharmacology, immunology or metabolism, or although these means are involved, they only play an auxiliary role.
The medical device industry involves many industries, such as medicine, machinery, electronics, plastics and so on. It is a multi-disciplinary, knowledge-intensive and capital-intensive high-tech industry. The basic characteristics of high-tech medical equipment are digitalization and computerization, which is the crystallization of modern high-tech interdisciplinary.