1, medical institutions are added to the hospital procurement catalogue.
2. Medical institutions edit purchasing information and generate purchase orders.
3. The distribution enterprise maintains the inventory (uploads the bill from the production enterprise to the distribution enterprise) and confirms the purchase order.
4. Distribution enterprise distribution (the distribution enterprise uploads the bill to the medical institution)
5. Receiving goods by medical institutions
Provisions on the administration of drug sales filing?
All pharmaceutical trading enterprises shall handle drug procurement and sales personnel filing with the local drug supervision department.
The filing system of drug sales personnel in operating enterprises refers to: (taking Taizhou, Jiangsu Province as an example)
Check the power of attorney, labor contract, ID card and other materials of the sales staff of pharmaceutical trading enterprises, and establish the basic database of the sales staff of enterprises.
Sales personnel who engage in illegal activities without registration, beyond the scope of authorization, forging business qualifications, etc. Once found, it will be recorded in the "blacklist of drug sales personnel" and punished according to law; If the case constitutes a crime, it shall be transferred to judicial organs for investigation according to law. At the same time, the relevant enterprises that illegally sell drugs and their legal representatives, quality leaders, etc. Will be included in the "blacklist of pharmaceutical trading enterprises" and announced to the public.
All pharmaceutical trading enterprises are required to conduct a comprehensive inventory of sales personnel, and all sales personnel who have not signed employment contracts with the enterprises are not allowed to provide business licenses, pharmaceutical trading licenses, GSP certification certificates and other relevant qualification certificates.
What is the filing process of drugs in the medical insurance bureau?
Go to the public hospital designated by medical insurance first. Within three working days of hospitalization, go to the hospital medical insurance office to register. When leaving the hospital, go to the medical insurance office to open the hospitalization approval form, hospitalization invoice, detailed list and case.
If it is a trauma, you should also go to the hospital medical insurance office, fill in the trauma form and affix the official seal of the hospital and the official seal of the insured unit, make a personal statement, and then submit the statement or certificate of the insured unit to the Social Labor and Social Security Bureau for reimbursement.
What is the declaration process of the Food and Drug Administration?
Taking the filing of drug packaging label instructions as an example, the procedures are as follows:
(a) the applicant shall submit the application materials to the administrative department of the Provincial Bureau. The administrative acceptance department of the provincial bureau shall conduct a review within 5 working days, and issue a notice of acceptance if it meets the specified requirements, and hand over the materials to the evaluation and certification center;
(two) the evaluation and certification center shall issue an audit opinion after completing the audit work within 15 working days, and hand over the materials to the drug and cosmetic registration management office;
(3) The Drug and Cosmetic Registration Office shall complete the examination within 10 working days, make an electronic version of the supplementary application case or the notice of approval, and hand it over to the Government Affairs Acceptance Office of the Provincial Bureau;
(4) The Drug and Cosmetic Registration Office will upload the electronic version of the supplementary application to the database of the General Administration within 5 working days; The administrative acceptance department of the Provincial Bureau shall issue a notice of examination and approval opinions to the applicant within 5 working days;
(five) shall be submitted to the the State Council for approval, in accordance with the provisions of the "measures" for the administration of drug registration;
(6) If it is really difficult to print the general name, specification, production batch number and expiration date of the internal labels of individual varieties due to special circumstances such as equipment and technology, it shall be accepted by the Provincial Bureau and reported to the National Bureau for examination and approval, and the labeling content may be reduced after approval.
What is the filing process of drug clinical trial institutions?
Application procedures for clinical trials of medical devices
I. Legal basis
1. Regulations on the Supervision and Administration of Medical Devices (Order No.650th of the State Council);
2. Measures for the Administration of Registration of in vitro Diagnostic Reagents (Order No.5 of China Food and Drug Administration);
3. Announcement of China Food and Drug Administration on Relevant Matters Concerning the Declaration of Clinical Trials of Medical Devices (Announcement No.87 of China Food and Drug Administration No.2015).
Second, the bidding conditions
1. The applicant is the relevant unit or agent within the jurisdiction of Liaoning Province;
2. The applicant shall obtain the business license and organization code certificate of the enterprise;
3 clinical trial products have been registered and tested and the conclusion is qualified;
4. The clinical trial project has passed the ethical review and signed an agreement or contract with the clinical trial institution.
Third, the application materials
1. medical device clinical trial record form (see annex) in duplicate;
2. A copy of the business license of the applicant or agent;
3. A copy of the opinions of the Ethics Committee;
4. A copy of the clinical trial agreement or contract between the applicant and the clinical trial institution;
Five copies of approval documents for clinical trials of medical devices (Category III medical devices that need to be approved for clinical trials).
The above application materials shall be true, complete, clear and tidy; Print on A4 paper, make cover and catalogue, arrange them in the above order, and bind them into a book; The copy should be clear and stamped with the official seal (multiple pages should be stamped with the riding seal) to check with the original; The same item in the application materials should be filled in the same way.
Four. Procedures and time limit for handling
1. The applicant shall submit the filing materials for clinical trials of medical devices to the Medical Device Registration Office of the US Food and Drug Administration in Liaoning.
2. Review and archiving. If the clinical trial filing form is complete, the submitted materials are complete and meet the formal requirements, it shall be filed on the spot, and the filing number shall be filled in the clinical trial filing form, stamped with the special seal for filing, and the applicant shall keep one copy; Not for the record, inform the applicant and explain the reasons.
After the applicant completes the clinical trial filing, if there is any change in the start and end date of the trial project, it should inform the original filing management department within 10 working days after the change, and keep the information change record.
Verb (abbreviation of verb) charging standard
It's free.