Practice Pharmacist Registration Management Measures for Comments! Such a penalty for the act of hanging up... (full text attached)

Pharmaceutical Network December 24 - In order to improve the management system for the registration of practicing pharmacists, the State Drug Administration revised the Interim Measures for the Registration and Administration of Practicing Pharmacists (State Drug Regulator No. 156), forming the Measures for the Administration of the Registration of Practicing Pharmacists (draft for comments) (hereinafter referred to as the Draft opinions), which was officially released on December 23rd, with a deadline of January 6, 2021.
opinion draft, the State Drug Administration's Accreditation Center for Practicing Pharmacists is responsible for the registration and management of practicing pharmacists.
who has obtained the Professional Qualification Certificate for Practicing Pharmacists, he shall apply to the registry of the place where he practises through the National Registered Management Information System for Practicing Pharmacists.
submit an application for registration online or paper materials on-site in accordance with the requirements of the registry.
practicing pharmacists should attend 90 hours of continuing education training per year, 1 credit per 3 hours, and a cumulative 30 credits per year.
, professional subjects are generally not less than two thirds of the total course time.
the State encourages practicing pharmacists to participate in practical training.
the Opinion Draft, the registration of practising pharmacists is valid for five years.
applicant is required to renew the registration, he shall apply to the registry of the place where he practises for renewal 30 days before the expiration of the validity period of the registration.
apply for a change of registration within 30 days before the expiration date of the validity period, and if the requirements are met, the validity period of the registration certificate shall be extended for five years from the date on which the change is granted.
a third of patients worldwide die from unreasonable medication, not the disease itself, according to the WHO.
obviously, in the pharmaceutical production, circulation and use of the link, equipped with the corresponding practicing pharmacists for quality supervision and pharmaceutical services, to ensure the safety of public drug use has a special significance.
data released last November by the National Drug Administration's Center for the Qualification of Practicing Pharmacists showed that more than 1.03 million people were qualified as practicing pharmacists nationwide, of whom only 460,000 were registered as practicing pharmacists in retail pharmacies.
based on this data, industry experts estimate that the current number of practicing pharmacists can only meet 70% of the demand of drug retailers, which means that the gap between practicing pharmacists is still very large.
The Opinion Draft clearly states that a practicing pharmacist shall, within the scope of his practice, supervise the drug quality and pharmaceutical service activities of the practicing unit, ensure that the drug management process continues to comply with the statutory requirements, advise, stop or refuse to perform the act or decision of the practicing unit in violation of relevant laws, regulations, departmental regulations and professional and technical norms, and report it to the relevant administrative department.
The Drug Administration Law stipulates that pharmacists or other pharmaceutical technicians who have been qualified in accordance with the law shall be involved in drug business activities.
The pharmacist who has been qualified according to law in the field of drug management refers to the practicing pharmacist, and other pharmaceutical technicians who have been qualified according to law include the title of the health (drug) series (including pharmacist, pharmacist, competent pharmacist, deputy director pharmacist, chief pharmacist), practicing pharmacist, etc.
to adhere to and improve the professional qualification access system for practicing pharmacists, adhere to the pharmaceutical business enterprises practicing pharmacists in accordance with the law equipped with the use requirements.
In principle, pharmaceutical retail enterprises operating prescription drugs and Class A over-the-counter drugs shall be equipped with practicing pharmacists, and drug retail enterprises operating only Class B over-the-counter drugs shall be equipped with qualified business personnel who have been assessed by the drug regulatory department.
Severe punishment of the act of hanging a certificate "Opinion Draft" emphasizes that, by deception, bribery and other improper means to obtain the "professional pharmacist registration certificate", by the licensing department to revoke the "practicing pharmacist registration certificate", within three years will not be registered as a practicing pharmacist;
If it is strictly prohibited to hang on to the Certificate of Registration of Practicing Pharmacists, if the registration unit of the holder does not conform to the actual work unit, the licensing department shall revoke the Registration Certificate of a Practicing Pharmacist and, within three years, shall not register the practicing pharmacist, which constitutes a crime, and shall be investigated for criminal responsibility in accordance with the law.
to buy, sell or lease the Certificate of Registration of Practicing Pharmacists, and shall be punished in accordance with relevant laws and regulations.
forging the registration documents of practicing pharmacists, once found, the department responsible for drug supervision and administration shall seize them on the spot and hold the user accountable;
not practice according to the scope or type of practice, the department responsible for drug supervision and administration shall order the correction within a specified period of time.
if the party refuses to correct it after the time has passed, it shall be given administrative punishment according to law; if it constitutes a crime, it shall be investigated for formal responsibility in accordance with the law.
addition, the drug supervision and administration department shall, in accordance with its administrative authority, establish a credit file for practicing pharmacists, record the results of daily supervision and inspection, investigation and punishment of illegal acts, etc., and publish and update them to the public in accordance with the law.
for those with bad credit records, increase the frequency of supervision and inspection, and implement joint disciplinary measures in accordance with the provisions of the State.
Chapter I General Provisions Of the Measures for the Registration and Administration of Practicing Pharmacists (Draft for Comments) Article 1 "Purpose/Legislative Basis" These Measures are formulated in accordance with the Drug Administration Law of the People's Republic of China, the Administrative Licensing Law of the People's Republic of China and the Regulations on the Professional Qualification System of Practicing Pharmacists.
Measures shall apply to the registration of practicing pharmacists and related supervision and management.
Article 3 "Registration Requirements" for practicing pharmacists to implement the registration system.
who hold the Professional Qualification Certificate of a Practicing Pharmacist may practise as a practicing pharmacist after they have obtained the Certificate of Registration of a Practicing Pharmacist.
4 (Management Agency) The State Drug Administration shall be responsible for the formulation and organization of policies for the registration of practicing pharmacists and shall guide the administration of the registration of practicing pharmacists throughout the country.
the State Drug Administration's Certified Pharmacist Qualification Center to assume the management of the registration of practicing pharmacists.
the drug supervision and administration departments of the people's governments of the provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the registration and administration of practicing pharmacists within their respective administrative areas. article
Article 5 (Information Construction) The State Drug Administration shall establish a national registration management information system for practicing pharmacists, and the National Drug Administration's Qualification Center for Practicing Pharmacists shall undertake the construction, management and maintenance of the registration information system for the management of practicing pharmacists throughout the country, and collect relevant information on the report.
Article 6 "Principles of Registration" The principle of openness, fairness and impartiality shall be followed in the implementation of the registration of practicing pharmacists.
Chapter II Registration Conditions and Contents Article 7 (Registration Conditions) The applicant for registration of a practicing pharmacist (hereinafter referred to as the applicant) must have the following conditions: (1) obtain the Professional Qualification Certificate of a practicing pharmacist ;(2) abide by the law, abide by professional ethics, have no bad information record;
Article 8 (No registration situation) If one of the following circumstances occurs, it shall not be registered: (1) it shall not have full civil capacity; (2) it shall not complete its continuing education and study in accordance with the provisions; (3) the period of transmission of Class A, Class B infectious diseases, the onset of mental illness and other health conditions shall not be suitable or competent for the corresponding business work; and (4) the State shall prescribe other circumstances in which it is not appropriate to engage in the business of practicing pharmacists.
9 of the Chinese People's Law, the registration of practicing pharmacists includes: the area of practice, the type of practice, the scope of practice, the practice unit.
The practice areas are provinces, autonomous regions and municipalities directly under the Central Government; the practice categories are pharmacy, Chinese medicine, pharmacy and Chinese medicine; the practice areas are pharmaceutical production, drug management and drug use; and the practice units are legitimate pharmaceutical production, operation, use and other units that need to provide pharmaceutical services.
Chapter III Registration Procedure Article 10 (Submission of Applications) Who has obtained the Professional Qualification Certificate of a Practicing Pharmacist shall apply for registration with the registry of the place where the practising pharmacist is practiseing through the National Registered Management Information System for Practicing Pharmacists.
submit an application for registration online or paper materials on-site in accordance with the requirements of the registry.
Article 11 (Application Information Requirements) The application for first registration requires the submission of the following materials: (1) the application form for the first registration of a practicing pharmacist (attached 1);(2) the Certificate of Professional Qualification of a Practicing Pharmacist ;(3) identification;
health check-up form issued by hospitals at or above the county level or within 6 months issued by disease prevention and control institutions at or above the county level (inclusive).
person who has obtained the qualification certificate, who has applied for the first registration one year after the date of approval of the qualification certificate, shall provide proof of credit for continuing education.
entrusting another person with the application for registration, the agent shall submit a power of attorney and the agent's identification documents.
the above materials are provided in accordance with the requirements of the registry, originals, copies or electronic materials.
supervision and administration departments of the people's governments of the provinces, autonomous regions and municipalities directly under the Central Government may, in accordance with the actual situation, increase the materials to be submitted.
12 (Commitment) When an applicant applys for registration, he shall truthfully submit the relevant materials to the registry and reflect the true situation, and shall be responsible for the authenticity of the application materials.
Article 13 If the application materials are incomplete or do not conform to the prescribed forms, the applicant shall be informed at one time within five working days of the full contents of the need to be corrected; if it is not informed within the time of receipt of the registration application materials, it shall be deemed to be accepted.
Article 14 (Information Acceptance) If the application materials are complete and conform to the prescribed form, or if the applicant submits all the correct application materials as required, the registration authority shall accept the application for registration.
the registration authority accepts or rejects the application for registration, the applicant shall be issued with a special seal and dated certificate stamped with this registry.
Article 15 (Time limit for examination and approval) The registration authority shall make a decision on the registration license within 20 working days from the date of accepting the application for registration.
decision cannot be made within 20 working days, it may be extended for ten working days with the approval of the person in charge of this registry and the applicant shall be informed of the reasons for the extension.
the registration authority makes a decision not to register a license in accordance with the law, it shall state the reasons and inform the applicant that he has the right to apply for administrative reconsideration or initiate administrative proceedings in accordance with the law.
decision of the registration authority to grant a registration license shall be made public.
registry and its staff have a duty of confidentiality with regard to the application materials submitted by the applicant.
Article 18 (Certificate) The Registration Authority shall issue to the applicant within ten working days from the date of the decision on the registration permit that the State Drug Administration shall issue the Uniform Style of the State Drug Administration (see annex 2) and the Registration Certificate of a Practicing Pharmacist stamped with the seal of the Registry Administration.
Article 19 The State Drug Administration shall have the right to order the drug supervision and administration department of the people's government of a province, autonomous region or municipality directly under the Central Government to review and correct the registration of a practicing pharmacist if it finds that the registration of a practicing pharmacist does not meet the prescribed conditions.
Article 20 (Certificate Management of Practicing Pharmacists) A practicing pharmacist shall properly keep the Certificate of Registration of a Practicing Pharmacist and shall not buy, sell, rent or alter it.
damage occurs, the party concerned shall promptly apply to the original licensing department for a replacement certificate with the certificate of damage.
loss occurs, the party concerned shall apply for replacement after publishing a statement in the provincial media in which the original license department is located.
Chapter IV Registration Change Article 21 (Application for Change) If an applicant requests a change of practice area, type of practice, scope of practice, or practice unit, he shall apply to the registry of the place where he intends to apply for practice for a change of registration procedure.
Article 22 (Renewal Application) The registration of a practicing pharmacist shall be valid for five years.
applicant needs to renew the registration, he shall apply to the registry of the place where he practises for renewal 30 days before the expiration of the validity period of the registration.
apply for a change of registration within 30 days before the expiration date of the validity period, and if the requirements are met, the validity period of the registration certificate shall be extended for five years from the date on which the change is granted.
Article 23 "Submission Materials" The application for change and renewal of registration requires the provision of the relevant application form for registration of practicing pharmacists (with 3, 4) and the change information of the submission materials listed in Article 13, the certificate of continuing education credits and the commitment to be free of violations of laws and regulations.
Article 24 (Credit Certificate Requirements) If a practising pharmacist's professional qualification certificate is obtained, if he or she has applied for registration in the current year or has applied for renewal of registration, he shall obtain a continuous continuing education credit certificate, and if he has obtained the Professional Qualification Certificate of a practicing pharmacist for more than five years, he shall provide at least five consecutive years of continuing education credit certificate.
the registration is granted by Article 25 (Effective Time), the validity period of the registration shall remain unchanged, and if the registration is granted for renewal, the validity period of the registration shall be recalculated.
article 26 (Deregistration) If a practicing pharmacist registers, the individual practicing pharmacist or his unit shall, within 30 days from the date of knowing or knowing, apply to the registry for cancellation of registration and fill out the application form for the cancellation of registration of a practicing pharmacist (annex 5).
registration authority of the State Administration of The People's Bank of China shall, upon verification, handle the cancellation of registration in accordance with the law.
(1) if the validity period of registration has not been renewed; (2) death or incapacion; (3) criminal punishment; (4) the registration license of a practicing pharmacist has been revoked in accordance with the law or the registration certificate of a practicing pharmacist has been revoked in accordance with the law.
(5) not practising in a practising unit for more than one month without valid reasons; (6) not fit to continue practising in a medical condition; (7) applying on his own initiative; (8) other circumstances in which registration shall be cancelled as stipulated in laws and regulations.
Chapter V Positions and Rights and Obligations Article 27 The following jobs shall be equipped with practicing pharmacists in accordance with the relevant requirements: (1) Pharmaceutical production enterprises: quality escanted person posts, quality management person-in-charge posts, production management person-in-charge posts, drug listing licensees after-sales consulting services posts and other posts.
(2) Pharmaceutical wholesale enterprises and drug retail chain headquarters: quality responsible for the post, quality management department head post, quality management post and other positions.
(3) Pharmaceutical retail enterprises: enterprise head post, quality person in charge post, pharmaceutical services and prescription reviewer post.
(4) Drug use units: drug management, prescription review and deployment, rational drug use guidance and other positions; (5) other units requiring pharmaceutical services: online real-time consultation, quality management and other positions.
Article 28 (Scope of practice).