Chapter I General Principles
Article 1 In order to strengthen the professional access management of pharmaceutical technicians, give full play to the role of licensed pharmacists in guiding rational drug use and strengthening drug quality management, and ensure the safety and effectiveness of public drug use, these Provisions are formulated in accordance with the Drug Administration Law of People's Republic of China (PRC), the Implementation Regulations of the Drug Administration Law of People's Republic of China (PRC) and the professional qualification system.
Article 2 The State implements the professional qualification system for licensed pharmacists and brings it into the unified planning of the professional qualification system for professional and technical personnel throughout the country.
Article 3 Licensed pharmacists refer to pharmaceutical technicians who have passed the national unified examination and obtained the Professional Qualification Certificate of Licensed Pharmacists in People's Republic of China (PRC) (hereinafter referred to as the Professional Qualification Certificate of Licensed Pharmacists) and are registered to practice in units that need to provide pharmaceutical services such as drug production, trading and use.
Licensed Pharmacist English Translation: Licensed Pharmacist.
Article 4 All units engaged in the production, marketing and use of drugs shall be equipped with corresponding licensed pharmacists, and the State Pharmaceutical Product Supervision and Administration shall be responsible for defining the positions of licensed pharmacists.
Fifth licensed pharmacists should participate in continuing education in accordance with the relevant provisions of the state. The State Administration of Pharmaceutical Products is responsible for guiding and supervising the continuing education of licensed pharmacists throughout the country, and the licensed pharmacists' trade associations undertake specific work. The state encourages licensed pharmacists to participate in practical training.
Article 6 Ministry of Human Resources and Social Security and the State Administration of Pharmaceutical Products shall be responsible for the policy formulation of the national licensed pharmacist qualification system, and guide, supervise and inspect the implementation of the system according to the division of responsibilities.
The administrative departments of human resources and social security and the pharmaceutical supervisory and administrative departments of all provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the implementation, supervision and management of the professional qualification system for licensed pharmacists within their respective administrative areas in accordance with the division of responsibilities.
Chapter II Examination
Article 7 A unified national outline, unified proposition and unified examination system shall be implemented for the professional qualifications of licensed pharmacists. It is held once a year in principle.
Article 8 The State Administration of Pharmaceutical Products shall be responsible for organizing the formulation of examination subjects and examination outlines, establishing examination question banks, organizing examination questions, and putting forward suggestions on examination qualification standards.
Ninth Ministry of Human Resources and Social Security is responsible for organizing the examination subjects and examination syllabus, and jointly with the State Administration of Pharmaceutical Products to supervise and guide the examination work and determine the qualified standards.
Article 10 People's Republic of China (PRC) citizens and persons of other nationalities who are allowed to work in China may apply for taking the professional qualification examination for licensed pharmacists if they meet one of the following conditions:
(1) Having a bachelor's degree or above in pharmacy or traditional Chinese medicine in an ordinary university; Bachelor degree or above in pharmacy or traditional Chinese medicine, and have been engaged in pharmacy or traditional Chinese medicine for one year;
(2) Having a college degree in pharmacy, traditional Chinese medicine and related majors, and having been engaged in pharmacy or traditional Chinese medicine for two years.
Article 11 For those who have passed the professional qualification examination for licensed pharmacists, the human resources and social security departments of all provinces, autonomous regions and municipalities directly under the Central Government shall issue the Professional Qualification Certificate for Licensed Pharmacists uniformly printed by Ministry of Human Resources and Social Security and the State Administration of Pharmaceutical Products. The certificate is valid nationwide.
Chapter III Notes
Twelfth licensed pharmacists to implement the registration system. The State Administration of Pharmaceutical Products shall be responsible for the formulation and implementation of policies for the registration of licensed pharmacists, and guide the registration management of licensed pharmacists throughout the country. The pharmaceutical supervisory and administrative departments of all provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the registration and administration of licensed pharmacists within their respective administrative areas.
Thirteenth persons who have obtained the "Professional Qualification Certificate of Licensed Pharmacists" shall apply for registration to the local registration management institution through the national registration management information system for licensed pharmacists. Only after practicing registration can they engage in corresponding practicing activities. Those who have not been registered for practice shall not practice as licensed pharmacists.
Article 14 An applicant for registration must meet the following conditions:
(1) Obtaining the professional qualification certificate of licensed pharmacists;
(two) abide by the law, abide by the professional ethics of licensed pharmacists;
(3) Being in good health and being able to persist in the work of licensed pharmacists.
Article 15 Where the registration is approved, the pharmaceutical supervisory and administrative departments of provinces, autonomous regions and municipalities directly under the Central Government shall issue the Licensed Pharmacist Registration Certificate with a uniform pattern to the State Administration of Pharmaceutical Products.
Sixteenth licensed pharmacists can only be registered in one province, autonomous region or municipality directly under the central government. A licensed pharmacist who changes his practice unit and scope shall go through the registration formalities in time.
Seventeenth licensed pharmacist registration is valid for five years, and if it needs to be renewed, it shall apply to the registration authority for renewal of registration 30 days before the expiration of the validity period. Re-registration, in addition to meeting the requirements of article fourteenth, should also be completed in accordance with the provisions of continuing education credits.
Chapter IV Obligations and Responsibilities
Eighteenth licensed pharmacists should abide by professional standards and business norms, to be responsible for the quality of drugs, to ensure the safety and effectiveness of public medication as the basic criteria.
Nineteenth licensed pharmacists must strictly implement the "Drug Administration Law of People's Republic of China (PRC)" and various state regulations and policies on drug research, production, sale and use. Licensed pharmacists have the responsibility to put forward suggestions, stop and refuse to implement acts or decisions that violate the Drug Administration Law of People's Republic of China (PRC) and relevant laws and regulations. Report illegal acts to the local drug supervision and administration department.
Twentieth licensed pharmacists are responsible for the supervision and management of drug quality within the scope of practice, and participate in the formulation, implementation and handling of violations of the total quality management of drugs in their own units.
Twenty-first licensed pharmacists are responsible for the examination and deployment of prescriptions, providing medication consultation and information, guiding rational drug use, and carrying out clinical pharmacy work such as therapeutic drug monitoring and drug efficacy evaluation.
Article 22 A pharmaceutical trading enterprise shall publicize the Licensed Pharmacist Registration Certificate in a prominent position, and list the licensed pharmacists who are practicing on the job. When licensed pharmacists are not on the job, pharmaceutical retail enterprises dealing in prescription drugs shall publicize them in a significant way and suspend the sale of prescription drugs.
Licensed pharmacists should wear work cards in accordance with relevant regulations when practicing.
Chapter V Supervision and Administration
Twenty-third pharmaceutical supervisory and administrative departments shall, in accordance with the provisions of relevant laws, regulations and rules, supervise and inspect the allocation of licensed pharmacists and their practice activities.
Supervision and inspection shall check the licensed pharmacist registration certificate, prescription audit record, licensed pharmacist listing express, licensed pharmacist on-the-job service and other matters.
Practice units and licensed pharmacists shall assist and cooperate with the supervision and inspection of the pharmaceutical supervisory and administrative departments, and shall not refuse or obstruct them.
Twenty-fourth in any of the following circumstances, the human resources and social security departments at or above the county level and the drug supervision and administration departments shall commend and reward them according to the regulations:
(a) in the practice activities, abide by professional ethics, outstanding deeds;
(2) Having made significant contributions in pharmaceutical work;
(three) outstanding performance in providing pharmaceutical services to patients;
(four) long-term work in grassroots units in remote and poor areas and outstanding performance.
Twenty-fifth licensed pharmacists' illegal behavior, acceptance of commendation and rewards, punishment and other information shall be timely input into the national licensed pharmacist registration management information system by the pharmaceutical supervisory and administrative department; Continuing education credits of licensed pharmacists shall be entered into the national licensed pharmacist registration management information system by continuing education institutions in a timely manner.
Twenty-sixth units that are not equipped with licensed pharmacists according to the regulations shall be ordered by the local pharmaceutical supervisory and administrative departments at or above the county level to be equipped within a time limit.
Twenty-seventh whoever obtains the "Professional Qualification Certificate of Licensed Pharmacists" by improper means, the issuing authority shall declare the certificate invalid and deal with it in accordance with the provisions of the national professional and technical personnel qualification examination; If a crime is constituted, criminal responsibility shall be investigated according to law.
Twenty-eighth by cheating, bribery and other improper means to obtain the "Licensed Pharmacist Registration Certificate", the license issuing department shall revoke the "Licensed Pharmacist Registration Certificate", and shall not register licensed pharmacists for three years; If a crime is constituted, criminal responsibility shall be investigated according to law.
If a licensed pharmacist's registration certificate is leased or lent, the issuing department shall declare the certificate invalid, order it to be recovered or confiscated, and shall not register a licensed pharmacist for three years. Those involved in illegal licensed pharmacists and illegal enterprises shall be punished in accordance with relevant laws and regulations.
Twenty-ninth licensed pharmacists in violation of the relevant provisions of these Provisions, the unit shall truthfully report, and the pharmaceutical supervisory and administrative department shall deal with it according to the situation.
Thirtieth licensed pharmacists in the course of practice in violation of the "Drug Administration Law" and other laws and regulations, which constitutes a crime, shall be investigated for responsibility by judicial organs according to law.
Chapter VI Supplementary Provisions
Thirty-first people who have obtained the professional qualification certificate of licensed pharmacists through the unified national examination and meet the evaluation conditions of corresponding titles are regarded as having the title of pharmacist in charge or pharmacist in charge.
Thirty-second "related majors" in these Measures shall be separately determined by the State Administration of Pharmaceutical Products and Ministry of Human Resources and Social Security.
Thirty-third Ministry of Human Resources and Social Security and the State Administration of Pharmaceutical Products will work with relevant departments to gradually promote the management of licensed pharmacists in ethnic medicine.
Thirty-fourth Hongkong, Macao and Taiwan Province residents to apply for participation in the national licensed pharmacist qualification examination, registration, continuing education, practice and other activities, in accordance with these provisions.
Thirty-fifth "People's Republic of China (PRC) licensed pharmacist professional qualification certificate" has the same effect. According to the Notice of the State Administration of Pharmaceutical Products and the Ministry of Personnel on Amending and Printing the Interim Provisions on the Qualification System of Licensed Pharmacists and the Implementation Measures for the Qualification Examination of Licensed Pharmacists (Guo Fa [1999] No.34), the qualification certificate of licensed pharmacists was obtained in accordance with these provisions.
Article 36 The Ministry of Human Resources and Social Security and the State Administration of Pharmaceutical Products shall be responsible for the interpretation of these Provisions in accordance with the division of responsibilities.
Article 37 These Measures shall come into force as of the date of promulgation.