Hubei Provincial Food and Drug Administration issued the implementation measures for the registration management of licensed pharmacists

On January 7, the Hubei Provincial Food and Drug Administration issued the "Implementation Measures for the Registration and Management of Licensed Pharmacists in Hubei Province".
The full text is divided into 5 chapters and a total of 26 articles
.
The original text is as follows: Notice of the Provincial Drug Administration on Printing and Distributing the Implementation Measures for the Registration and Administration of Licensed Pharmacists in Hubei Province All cities, prefectures, municipalities directly under the control of Shennongjia Forest District Market Supervision Administration, various offices, branches and directly affiliated units of the provincial bureau: The "Implementation Measures for the Registration and Administration of Licensed Pharmacists in Hubei Province" has been reviewed and approved by the Office of the Provincial Bureau Chief, and is hereby issued to you.
Please follow the implementation of Hubei Provincial Drug Administration January 5, 2022 (public attribute: active disclosure) Hubei Province Licensed Pharmacists Chapter 1 General Provisions of the Implementation Measures for Registration Management Article 1 In order to further standardize the registration management of licensed pharmacists and their practice activities, these measures are formulated in accordance with the Administrative Measures for the Registration of Licensed Pharmacists (Guoyao Jianren [2021] No.
36)
.
Article 2 The Provincial Drug Administration is responsible for the supervision and administration of the registration of licensed pharmacists within its administrative region
.
The city (state) drug administration department shall specifically undertake the registration of licensed pharmacists
.
The Provincial Licensed Pharmacists Association is entrusted by the Provincial Drug Administration to undertake the continuing education and management duties of licensed pharmacists, and consciously accepts the supervision and guidance of the Provincial Drug Administration
.
Provincial and municipal (prefecture) drug regulatory departments shall set up provincial administrators, registration approval administrators, continuing education credit administrators and market supervision administrators, with specific responsibilities as follows: (1) Provincial registration system administrators: responsible for the identity of licensed pharmacists Maintenance of basic card number and registration information, and review of user operation logs in the province
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(2) Registration Approval Administrator: Responsible for registration approval processing in the jurisdiction, printing of relevant materials, consultation and processing, maintenance of basic information such as the year, province, registration unit, and professional category of the licensed pharmacist examination
.
The city (prefecture) registration approval administrator is entrusted by the provincial drug regulatory department to be responsible for the registration approval processing in its jurisdiction, and the specific responsibilities are the same as the provincial registration approval administrator
.
(3) Continuing education credit administrator: responsible for the introduction of continuing education credits, credit inquiry, and statistical analysis
.
(4) Market supervision administrator: responsible for entering records of licensed pharmacists’ inspections and rewards and punishments
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The staffing and changes of licensed pharmacists can be inquired through the registration system for on-site inspection
.
Article 3 To practice, a licensed pharmacist shall obtain a Licensed Pharmacist Registration Certificate after registration
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Those who have not obtained the Licensed Pharmacist Registration Certificate shall not engage in pharmaceutical service activities as a licensed pharmacist
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Article 4 The state establishes a registration management information system for licensed pharmacists
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Provincial and municipal (prefecture) drug supervision and administration departments implement the registration management of licensed pharmacists in accordance with the "National Licensed Pharmacist Registration Management Information System Management Specification"
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Article 5 The electronic certificate issuance system of the Licensed Pharmacist Registration Certificate shall be implemented
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The format of the electronic certificate is the same as that of the State Drug Administration
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Electronic certificates have the same effect as paper certificates
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If a licensed pharmacist needs a paper certificate for renewal of registration or change of registration in another province, the city (state) drug regulatory department shall issue it in accordance with the regulations
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Chapter II Registration Management Article 6 When a licensed pharmacist applies for registration, the scope of its practice activities and the practice unit shall comply with the following provisions: (1) If the practice unit is the holder of the drug marketing license, the practice scope is drug production
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(2) Where the practice unit is a third-party logistics enterprise for pharmaceuticals or a third-party platform for online drug sales, the scope of practice is pharmaceutical business
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(3) If the practice unit is a third-party platform for remote review, the scope of practice is the use of drugs
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Article 7 The applicant shall submit the corresponding licensed pharmacist registration application form and materials online in accordance with the requirements for initial registration, change registration or renewal registration
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(1) The drug regulatory department shall formulate requirements and upload procedures for electronic materials, and publish guidelines for handling matters
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Among them, the legal business operation certificate of the practice unit refers to the drug production license, drug business license, medical institution practice license or third-party platform qualification certificate,
etc.
(2) If it is due to the national licensed pharmacist registration management information system (hereinafter referred to as the information system), rather than the authenticity and compliance of the submitted materials, the drug regulatory department shall, after verifying the licensed pharmacist qualification certificate information, follow the "First Processing, and reporting after the principle of acceptance and registration license approval
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(3) Regarding the problem that the information system is not compatible with the registration management, the registration and approval administrator of the drug regulatory department undertook may directly report to the registration system administrator of the State Drug Administration
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(4) The administrator of the provincial registration system regularly collects opinions and suggestions on the registration management of licensed pharmacists, and reports to the licensed pharmacist center of the State Drug Administration
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Article 8 In addition to the provisions of Article 8 of the "Administrative Measures for the Registration of Licensed Pharmacists", if any of the following circumstances occurs, the registration shall not be granted within the prescribed time limit: (1) The registration unit of the licensee is inconsistent with the actual work unit, and it is verified that it belongs to " Those who are affiliated with the Licensed Pharmacist Registration Certificate, or are subject to the administrative penalty of revocation of the Licensed Pharmacist Registration Certificate, within three years from the date of the penalty decision to the date of application for registration
.
(2) Those who obtain the Licensed Pharmacist Registration Certificate by fraud, bribery or other improper means and are revoked in accordance with the law, will not be registered within three years
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(3) For those who buy, sell, or lease the Licensed Pharmacist Professional Qualification Certificate or Licensed Pharmacist Registration Certificate, the relevant Licensed Licensed Pharmacist Registration Certificate shall be cancelled and registration shall not be granted within two years
.
(4) Those who forge the Professional Qualification Certificate for Licensed Pharmacists or the Registration Certificate for Licensed Pharmacists are found to be confiscated in accordance with the regulations, and they will not be registered within five years if they are licensed pharmacists
.
(5) For those who violate the "Drug Administration Law", such as giving licensed pharmacists ten years or even lifelong bans from engaging in drug production and business activities, they will not be registered during the industry ban period. .
Article 9 Where the same practice unit has multiple practice locations in the province, licensed pharmacists may apply for registration at the drug regulatory department where the practice unit (such as the headquarters of a drug retail chain enterprise, the holder of a drug marketing license, or the headquarters of a drug manufacturer) is located.
And within 15 working days, it should be filed with the drug supervision and administration department where the practice location is located, indicating the name of the practice location (such as chain stores, drug marketing license holders, or branch companies of drug manufacturers, etc.
)
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(1) The "Registration and Filing Information Form of the Practice Site of Licensed Pharmacists" (see the attachment) shall be retained by the practice unit for future reference
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(2) When renewing the registration or changing the registration, the drug supervision and administration department shall regard the practice place and the name of the practice unit as the same as the "Registration and Recordation Information Form of the Practice Site of Licensed Pharmacists"
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(3) The time interval for changing the name of a licensed pharmacist's practice location by a practice unit is not less than 2 months
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If a licensed pharmacist finds that the practice unit violates the provisions of these measures, it is responsible for advising, stopping, refusing to implement and reporting to the drug supervision and administration department
.
Otherwise, it will be dealt with in accordance with the relevant provisions of this method
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Article 10 A licensed pharmacist in a hospital pharmacy on duty can provide pharmaceutical services such as drug consultation, prescription review, and prescription review for social pharmacies, but does not have the right to sign the prescription review
.
If a licensed pharmacist in a hospital pharmacy on duty is engaged in related pharmacy service activities part-time in a social pharmacy, he or she shall report to the local drug supervision and administration department, and the social pharmacy shall assume the main responsibility for the pharmacy service activities provided
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Article 11 For those that meet the registration application, the drug regulatory department shall make a registration license decision within 2 working days; for a registration application that needs to be corrected or filed, a registration license decision shall be made on the same day
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Within 3 working days after the drug supervision and administration department makes the decision on registration license, the "licensed pharmacist registration certificate" or the "licensed pharmacist's practice location registration information form" shall be issued to the practicing unit or the applicant
.
Article 12 If the registration or filing conditions are not met, the drug regulatory department shall notify the practice unit and the applicant in writing within 20 working days from the date of receipt of the registration or filing application, and explain the reasons. .
If the applicant has any objection, he may apply to the provincial drug regulatory department for administrative reconsideration or file an administrative lawsuit in the people's court
.
Article 13 If the Provincial Drug Administration finds that the registration of licensed pharmacists does not meet the prescribed conditions, it has the right to order the city (state) drug administration to review and make corrections
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Article 14 A licensed pharmacist shall properly keep the Licensed Pharmacist Registration Certificate, and shall not buy, sell, lease or alter
.
If the paper "License Pharmacist Registration Certificate" is damaged, the party concerned shall apply to the original issuing department for a replacement with the damaged certificate in time
.
In the event of loss of the paper Licensed Pharmacist Registration Certificate, the party concerned shall apply to the original certificate-issuing department for a replacement
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The issuing department shall publish the statement of loss on the website
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Chapter III Registration Change Article 15 After a licensed pharmacist is registered, in addition to the provisions of Article 24 of the Measures, if any act of lending, leasing, mortgage, transfer, or altering the Licensed Pharmacist Registration Certificate occurs, the practicing unit where he works shall Report to the drug supervision and administration department that undertakes the registration within 30 days from the date of knowing or should know, and cancel the registration
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Article 16 If a licensed pharmacist resigns from a drug production, distribution or user unit after registration, the practice unit where he works shall report to the drug regulatory department that undertakes the registration within 30 days from the date of going through the relevant formalities
.
If 2 years have passed since the report and the licensed pharmacist has not continued to practice, the Licensed Pharmacist Registration Certificate will be cancelled
.
Article 17 If a licensed pharmacist changes registration matters such as practice location, practice category, practice scope, etc.
across provinces, he or she shall go through the registration modification formalities again at the local drug regulatory department in accordance with the provisions of the Measures
.
If a licensed pharmacist undertakes pharmaceutical service activities in a relevant practice unit due to emergencies such as epidemics, disasters, etc.
, there is no need to go through the procedures for changing the practice unit or filing the practice location
.
Article 18 For those who meet the application for registration change or registration renewal, the drug regulatory department shall make a decision on registration change permission within 2 working days, and issue the Licensed Pharmacist Registration Certificate to the practicing unit or applicant within 3 working days.
Or the "Registration and Filing Information Form for the Practice Site of Licensed Pharmacists"
.
Chapter IV Continuing Education Article 19 The Provincial Association of Licensed Pharmacists shall establish a management system for the continuing education of licensed pharmacists, which shall at least include the development plan and guidelines for the continuing education of licensed pharmacists, the organization and management of training, the filing of teaching institutions and the management of teacher appointments, The content and form of training, the construction of training materials, the annual training plan, the evaluation of teaching quality, the management of credits, and the management of information and credit, etc.
, ensure the quality of continuing education for licensed pharmacists
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Article 20 Continuing education for licensed pharmacists may be appropriately charged according to relevant state regulations, with the principle of cost compensation and not for profit
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The practicing unit shall bear the expenses required for the continuing education of licensed pharmacists
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Licensed pharmacists are treated as on-the-job during continuing education
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The Provincial Drug Administration shall strengthen the supervision and inspection of the continuing education activities of the Provincial Licensed Pharmacists Association, and the Provincial Licensed Pharmacists Association shall be regularly audited by the auditing department
.
Article 21 The continuing education of licensed pharmacists shall implement an annual plan management system
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The annual continuing education plan should focus on scientificity, pertinence, practicality and advancement, and the educational form should reflect the principles of effectiveness, convenience and economy
.
(1) The annual continuing education plan is formulated by the Provincial Association of Licensed Pharmacists and reported to the Provincial Drug Administration for review and recordation
.
(2) The Provincial Drug Administration may organize industry experts and industry representatives to review, evaluate and record the annual continuing education plan
.
(3) The Provincial Association of Licensed Pharmacists shall carefully organize the implementation of the filed annual continuing education plan, and generally shall not change it without authorization
.
If it is really necessary to change, it should be reported to the filing department
.
(4) Implement the annual continuing education plan statistics and teaching quality review and analysis system, and the provincial licensed pharmacists association submits relevant statistics and analysis reports to the filing department every year
.
Article 22 The drug regulatory authorities of each city (state) confirm or verify the continuing education credits of licensed pharmacists according to the relevant rules for the granting of continuing education credits for licensed pharmacists, and the Provincial Association of Licensed Pharmacists shall actively cooperate
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Article 23 The Provincial Association of Licensed Pharmacists shall establish and improve a system for the collection, registration and inquiry of the confirmation information of the continuing education credits of licensed pharmacists, and exchange data with the information of the licensed pharmacist registration information system, when handling registration and licensing matters for the drug supervision and administration department The basis for verifying continuing education credits for licensed pharmacists
.
(1) It can be automatically identified and confirmed according to the relevant rules for the granting of continuing education credits for licensed pharmacists, and audit tracking can be realized
.
(2) Data exchange can be achieved with the registration and management systems of continuing education credits such as the Chinese Pharmaceutical Association and the Chinese Pharmacists Association
.
(3) Realize data exchange with the continuing education credit registration management system for licensed pharmacists in other provinces, and can query through the licensed pharmacist registration management information system
.
Chapter V Supplementary Provisions Article 24 The drug supervision and administration department is encouraged to establish a management system for bad information records of licensed pharmacists in combination with drug supervision, inspection and audit work.
The bad information records shall be kept for five years and verified at the time of registration
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Article 25 The electronic registration management of licensed pharmacists shall be gradually promoted throughout the province
.
Explore the construction of a licensed pharmacist registration card in the China (Hubei) Pilot Free Trade Zone
.
(1) The registered practice scope of the free trade zone marked on the licensed pharmacist's electronic registration certificate; (2) The practicing unit reports the licensed pharmacist's practice location, and the drug supervision and management department records it on the licensed pharmacist's registration card; (3) Realize the practice of practice Pharmacist registration, credit information resource sharing and dynamic update
.
Article 26 These Measures shall come into force on the date of promulgation
.