Hebei Food and Drug Administration, within the scope of this province, the current registered capital of enterprises belongs to the general.
View more information and information of the US Food and Drug Administration in Hebei through online corporate credit.
B. Hebei Province Drug Filing Process Department
Supplementary matters such as drug instructions, packaging materials, packaging specifications, and drug re-registration need to be filed with the provincial drug administration. You can call the local drug supervision department.
C. Hebei pharmacies apply for medical insurance
I'll buy insurance for you. More questions can be answered online.
Apply every two years, but the application must meet certain qualifications and conditions:
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You should first understand the relevant regulations and have certain qualifications according to the regulations, and then fill in> with the approval of the local medical insurance management department, it is ok!
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Article 1 In order to strengthen and standardize the management of designated retail pharmacies for urban workers' basic medical insurance, these Measures are formulated in accordance with the Decision of the State Council on Establishing the Basic Medical Insurance System for Urban Workers (Guo Fa [1998] No.44).
Article 2 The term "designated retail pharmacies" as mentioned in these Measures refers to retail pharmacies that provide prescription dispensing services for the insured persons of basic medical insurance for urban workers, which have been audited by the administrative department of labor and social security in the overall planning area and determined by social insurance agencies. Prescription adjustment refers to the behavior of the insured to purchase drugs from designated retail pharmacies with prescriptions from designated medical institutions.
Article 3 The principles for examining and determining designated retail pharmacies are as follows: ensuring the variety and quality of drugs used in basic medical insurance; Introducing competition mechanism to control the cost of drug service reasonably; It is convenient for the insured to purchase drugs and manage after seeing a doctor.
Article 4 Designated retail pharmacies shall meet the following qualifications and conditions:
(1) Holding a Pharmaceutical Trading Enterprise License, a Pharmaceutical Trading Enterprise Certificate and a Business License, and passing the annual inspection by the pharmaceutical supervisory and administrative department;
(2) Abide by the Drug Administration Law of People's Republic of China (PRC) and relevant laws and regulations, and have a sound drug quality assurance system to ensure the safety, effectiveness and service quality of drug supply;
(three) strictly implement the drug price policies stipulated by the state and provinces (autonomous regions and municipalities directly under the central government), and pass the supervision and inspection of the price department.
(four) have the ability to supply basic medical insurance drugs in time and provide 24-hour service;
(five) to ensure that at least/kloc-0 pharmacists are on duty during business hours, and the business personnel must be trained and qualified by the drug supervision and administration department at or above the prefecture level;
(six) strictly implement the relevant policies and regulations of the basic medical insurance system for urban workers, have a standardized internal management system, and be equipped with necessary management personnel and equipment.
Fifth retail pharmacies willing to undertake the designated service of basic medical insurance for urban workers shall submit a written application to the administrative department of labor and social security in the overall planning area, and provide the following materials:
A copy of the license, certificate and business license of the pharmaceutical trading enterprise;
(2) Certificate of professional title of pharmaceutical technicians above pharmacist;
(3) List of drug varieties and business income and expenditure of the previous year;
(4) Certification materials of drug supervision and administration and supervision and inspection by the price department;
(five) other materials prescribed by the administrative department of labor security.
Article 6 The administrative department of labor security shall examine the qualifications of retail pharmacies according to their applications and materials provided.
Seventh overall regional social insurance agencies in the retail pharmacies with designated qualifications to determine the designated retail pharmacies, unified distribution of designated retail pharmacies signs, and announced to the public, for the insured to choose medication.
Article 8 A social insurance agency shall sign an agreement with a designated retail drugstore, which includes the service scope, service content, service quality, drug expense settlement method, drug expense audit and control, etc. , to clarify the responsibilities, rights and obligations of both parties. The validity period of the agreement is generally 1 year. If either party violates the agreement, the other party has the right to terminate the agreement, but it must notify the other party and the insured in advance and report to the administrative department of labor security for the record.
Article 9 Prescriptions for external use must be issued by doctors in designated medical institutions, signed by doctors and sealed by designated medical institutions. Prescriptions must be examined and signed by pharmacists and kept for more than 2 years for verification.
Tenth designated retail pharmacies should be equipped with full-time (part-time) management personnel, and cooperate with social insurance agencies to do a good job in various management work. Prescriptions for external use should be managed separately, and separate accounts should be established. Designated retail pharmacies should regularly report the occurrence of prescription dispensing services and expenses to the social insurance agencies in the overall planning area.
Eleventh social insurance agencies should strengthen the inspection and cost audit of prescription dispensing services in designated retail pharmacies. Designated retail pharmacies are obliged to provide materials and account lists related to cost audit.
Twelfth social insurance agencies shall, in accordance with the relevant policies and regulations of basic medical insurance and the agreement signed with designated retail pharmacies, settle the expenses in full and on time. In violation of the provisions of the fees, social insurance agencies will not pay.
Thirteenth labor and social security administrative departments shall organize relevant departments such as drug supervision and management, price and pharmaceutical industry, and strengthen supervision and inspection of prescription dispensing services and management of designated retail pharmacies. Annual review of the qualifications of designated retail pharmacies. Designated retail pharmacies in violation of regulations, the labor and social security department may, according to different situations, order them to correct or cancel their designated qualifications within a time limit.
Article 14 The application form for designated retail pharmacies shall be uniformly formulated by the Ministry of Labor and Social Security.
Fifteenth provinces (autonomous regions and municipalities directly under the central government) administrative departments of labor security may formulate detailed rules for implementation according to these measures.
Article 16 These Measures shall come into force as of the date of promulgation.
D. can Hebei province centralized drug procurement network go up these two days?
I checked here, and the website can be opened, and all interfaces are normal. ...
E. Main responsibilities of the US Food and Drug Administration in Hebei
(a) to formulate policies, plans and supervise the implementation of food safety supervision and management of drugs, medical devices and consumption and health supervision and management of health food and cosmetics in the province; Participate in drafting relevant local regulations.
(two) responsible for food hygiene licensing and food safety supervision and management in the process of consumption.
(three) to supervise the implementation of food safety management norms in consumption; Carry out food safety investigation and monitoring in the field of consumption, and release relevant information on food safety supervision in the field of consumption.
(four) in accordance with the provisions of the cosmetics hygiene license, hygiene supervision and management and cosmetics approval.
(five) responsible for the administrative supervision and technical supervision of drugs and medical devices, and supervise the implementation of quality management standards for the development, production, circulation and use of drugs and medical devices.
(six) responsible for the registration, supervision and management of drugs and medical devices, and supervise the implementation of national standards for drugs and medical devices; Organize and monitor adverse drug reactions, medical device adverse events and drug abuse; Re-evaluation and elimination of drugs and medical devices; Cooperate with relevant departments to implement the national essential drug system; Organize the implementation of the national classified management system for prescription drugs and over-the-counter drugs.
(seven) to organize the implementation of Chinese medicine and ethnic medicine supervision and management norms, and supervise the implementation of Chinese herbal medicine production quality management norms and Chinese herbal medicine processing norms; Implement the protection system of traditional Chinese medicine varieties according to law.
(eight) to issue licenses for pharmaceutical and medical device manufacturing enterprises, trading enterprises and medical units according to law.
(nine) to supervise and inspect the quality of drugs and medical devices produced and operated by enterprises and medical institutions; Supervise and manage toxic drugs for medical use, * * products, * *, radioactive drugs, pharmaceutical precursor chemicals and drug-induced stimulants; Release information on the quality and safety of drugs and medical devices.
(ten) to investigate and deal with food safety and illegal acts in the research and development, production, circulation and use of drugs, medical devices and cosmetics.
(eleven) to organize, guide and supervise the supervision and management of food safety and cosmetic hygiene in the province.
(twelve) to carry out exchanges and cooperation related to food and drug supervision and management.
(thirteen) responsible for the examination and approval of drugs and medical devices; Responsible for the examination of health food advertisements.
(fourteen) to organize the implementation of the qualification system for licensed pharmacists; Responsible for the training of relevant personnel of food and drug supervision and management in the province; Organize the implementation of the food and drug-related professional and technical post evaluation and the professional qualification access system for employees.
(fifteen) to undertake other tasks assigned by the provincial * * * and the provincial health department.
F. List of medical insurance drugs for employees in Hebei Province
I'll buy insurance for you. More questions can be answered online.
Enter the medical insurance catalogue for drug approval.
Project Name: Medical Insurance Catalogue Drug Approval
Category: Non-administrative license approval
Scope of jurisdiction: drugs listed in People's Republic of China (PRC) Pharmacopoeia (current edition); Drugs that meet the standards issued by the state drug supervision and administration department; Drugs officially imported and other drugs that meet the requirements approved by the state drug supervision and administration department.
Implementation basis: Notice of the Labor and Social Security Department of Hebei Province on Printing and Distributing the Drug List of Basic Medical Insurance and Work Injury Insurance in Hebei Province (Ji Lao She [2005]18).
Acceptance conditions: Drugs that have obtained the drug registration approval of the State Pharmaceutical Products Administration, the trademark registration approval of the State Administration for Industry and Commerce (domestic or joint venture) or the import drug registration certificate of the State Pharmaceutical Products Administration can be included in the catalogue.
Application materials:
1 Hebei province basic medical insurance and industrial injury insurance drug registration form
2. Examination and approval of drug registration by the State Administration of Pharmaceutical Products and trademark registration by the State Administration for Industry and Commerce (domestic capital and joint venture).
3. Registration Certificate of Imported Drugs of the State Administration of Pharmaceutical Products (Import)
4. Instructions for use
5. External packaging box
Handler:
1, the unit is applicable;
2, the administrative department of labor security for preliminary examination and summary;
3, the provincial labor and social security departments for approval.
Undertaking department: Medical Insurance Department of Tangshan Labor and Social Security Bureau
Address: Tangshan Labor and Social Security Bureau
Review method: written review.
Authorized by: Director of Tangshan Labor and Social Security Bureau.
Organizer: Han Tel: 03 15—2802700.
Reviewer: Mo Huanyan Tel: 03 15—2802700
Time limit for processing: within 30 working days from the date of acceptance.
Charging standard: no charge.
Publicity scope: open to the public
Open form: network
Opening hours: Long-term opening
Service Commitment: Complete the preliminary review summary within 30 working days from the date of acceptance and report it to the provincial office.
Counterpart complaint channel: If you are not satisfied with the preliminary ruling result, you can complain to the supervision office of the Municipal Labor and Social Security Bureau through public telephone.
Work discipline: do not ask for or accept the applicant's finance, do not seek other benefits, do not change or change the handling procedures without authorization, and do not exceed authority or abuse power.
Supervision link: from the date of acceptance, by truthfully filling in the dynamic operation table of administrative power, accept the supervision of the supervision department.
Accountability: according to the provisions of relevant provincial and municipal documents.
G. What do you need to change the registration of licensed pharmacists in Hebei Province?
Hello, Xingheng Education will answer your questions.
1. Application form for change of registered pharmacist (in duplicate);
2. Licensed pharmacist qualification certificate;
3. The original registration certificate of licensed pharmacist (original and photocopy);
4. Certificate of continuing education for licensed pharmacists;
5. The original and photocopy (copy of A4 copy paper) of the health examination form issued by the hospital or medical examination center at or above the county level for the last 6 months shall be submitted together. After checking the original and its copy, the accepting personnel will return the original health check-up form to the applicant at that time and keep the copy on file.
6. Two one-inch photos of recent documents (the same as the bottom edition);
7. Certificate of legal operation of the registered entity:
Registered in a pharmaceutical production unit, a copy of the Pharmaceutical Production License (original) shall be provided, and the copy shall be copied on A4 paper and stamped with the official seal.
If registered in a pharmaceutical business entity, a copy (original) of the Pharmaceutical Business License shall be provided, and the copy shall be copied on A4 paper and stamped with the official seal.
If registered as a drug user, a copy (original) or (copy) of the Practice License of Medical Institution shall be provided, and the copy shall be copied on A4 paper and stamped with the official seal.
8. Original and photocopy of the formal employment contract of the labor department (on-the-job certificate provided by the registered personnel of the drug-using unit)
Matters needing attention in changing the registration of licensed pharmacists
When applying for registration outside the province, an Application Form for Registration Change of Licensed Pharmacists (in triplicate) shall be provided; There is no need to provide the original (original and copy) of the Licensed Pharmacist Registration Certificate.
The provinces may be slightly different, depending on the regulations of the local food and drug administration.
H. Off-site drug supervision system in Hebei Province
If there is an off-site drug supervision system in Hebei Province, you can inquire from official website.
First, how to query the records of the salesmen of Hebei Pharmaceutical Company?
//hebfdea/ Hebei American Food and Drug Administration Medicine Integrity Network
To query this, just click Public Query and enter what you want to query.