Measures for the Quality Supervision and Administration of the Distribution and Use of Medicinal Products

Measures for the Quality Supervision and Administration of the Distribution and Use of Medicinal Products

(Issued by Order No. 84 of the State Administration for Market Regulation on September 27, 2023 and shall come into force on January 1, 2024)

Chapter I General Provisions

Article 1 These Measures are developed in accordance with the Pharmaceutical Administration Law of the People's Republic of China (hereinafter referred to as the “Pharmaceutical Administration Law”), the Vaccine Administration Law of the People's Republic of China, the Regulations on the Implementation of the Pharmaceutical Administration Law of the People's Republic of China, and other laws and administrative regulations, for the purposes of strengthening the quality supervision and administration of the Distribution and use of medicinal products, and regulating the administrative activities for the quality of distribution and use of medicinal products.

Article 2 The administration of the quality of distribution and use of medicinal products and its supervision and administration activities within the territory of the People's Republic of China shall comply with these Measures.

Article 3 Those who carry out wholesale or retail activities of medicinal products shall obtain approval of the medical products administrative department, obtain a medicinal products distribution license according to the law, and strictly comply with the laws, regulations, rules, standards and norms.

A holder of medicinal products marketing authorization may sell the medicinal products for which a medicinal product registration certificate has been obtained on its own, or entrust sale to a medicinal products distribution enterprise. However, a holder of medicinal products marketing authorization carrying out medicinal products retail activities shall obtain a medicinal products distribution license.

Other entities carrying out storage, transportation and other related activities of medicinal products shall comply with the relevant provisions of these Measures.

Article 4 A medical institution shall establish a medicinal products quality management system and be responsible for the quality management of medicinal products during the whole process of purchase, storage and use of its medicinal products. Where radioactive medicinal products and other medicinal products under special administration are used, relevant licenses for use shall be obtained in accordance with the relevant provisions.

Medicinal products using entities other than medical institutions shall comply with the provisions of these Measures on the quality management of medicinal products in the whole process of purchase, storage and use of medicinal products by medical institutions.

Article 5 Holders of medicinal products marketing authorization, medicinal products distribution enterprises and medical institutions shall comply with the unified standards and norms for traceability of medicinal products developed by the National Medical Products Administration, establish and implement the medicinal product traceability system, provide traceability information in accordance with the provisions, and ensure traceability of medicinal products.

Article 6 The National Medical Products Administration shall be responsible for the quality supervision and administration of the distribution and use of medicinal products across the country, and guide the quality supervision and administration of the distribution and use of medicinal products by the medical products administrative departments of provinces, autonomous regions and municipalities directly under the Central Government.

The medical products administrative departments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the quality supervision and administration of the distribution and use of medicinal products within their respective administrative regions, the licensing, inspection and punishment of medicinal product wholesale enterprises and headquarters of medicinal products retail chains, and the inspection and handling of the sales activities of holders of medicinal products marketing authorization; and guide the quality supervision and administration of the distribution and use of medicinal products by the departments responsible for medicinal product supervision and administration of the people's governments at the districted city level and county level (hereinafter referred to as the “medical products administrative departments at the municipal and county level”) according to their duties.

The medical products administrative departments at the municipal and county level shall be responsible for the quality supervision and administration of the distribution and use of medicinal products within their respective administrative regions, and the licensing, inspection and punishment of medicinal products retail enterprises, as well as the inspection and punishment of the quality of use of medicinal products.

The State Administration for Market Regulation shall, in accordance with the relevant provisions, strengthen the guidance of the comprehensive law enforcement team for market regulation.

Article 7 The National Medical Products Administration shall develop the quality management specifications for the distribution of medicinal products and the guiding principles for on-site inspection. The medical products administrative departments of provinces, autonomous regions and municipalities directly under the Central Government may develop detailed inspection rules in accordance with these Measures, the quality management specifications for the distribution of medicinal products and the guiding principles for on-site inspection, and in light of the actual circumstances of their respective administrative regions.

Chapter II Business Permit

Article 8 An entity carrying out medicinal product wholesale activities shall meet the following conditions:

(1) It has the quality management institution and personnel appropriate to its business scope; and its legal representative, primary person in charge, person in charge of quality, person in charge of quality management department, etc. meet the prescribed conditions.

(2) It has legally certified pharmacists and other pharmaceutical technicians.

(3) It has self-operated warehouses, business premises, facilities and equipment commensurate with its business variety and scale, and there are modern logistics facilities and equipment to realize operation of medicinal products warehousing, transmission, sorting, shelving and delivery in its warehouses.

(4) It has a quality management system ensuring the quality of medicinal products and an information management system covering the whole process of distribution, quality management and traceability of medicinal products, and it satisfies the requirements of the quality management specifications for the distribution of medicinal products.

Article 9 An entity carrying out medicinal product retail chain business activities shall set up a medicinal product retail chain headquarters to conduct unified management of retail stores. The headquarters of a medicinal product retail chain shall meet the conditions stipulated in items (1), (2) and (4) of Article 8 of these Measures, and have warehouses, distribution sites and facilities that may guarantee the quality of medicinal products and be compatible with its business varieties and scale.

Article 10 An entity carrying out medicinal product retail activities shall meet the following conditions:

(1) An entity distributing prescription medicinal products and class-A non-prescription medicinal products shall, in accordance with the provisions, appoint legally certified pharmacists or other pharmaceutical technicians appropriate to the business scope and variety. An entity that only distributes class-B non-prescription medicinal products may appoint medicinal product sales personnel who have passed the examination organized by the medical products administrative departments at the districted city level.

(2) It has the business premises, equipment, display and storage facilities and a sanitary environment suitable for the medicinal products distributed; where an entity concurrently distributes other commodities (non-medicinal products), its display and storage facilities shall be set up separately from medicinal products; and an entity carrying out medicinal product retail activities at supermarkets and other places shall have an independent business area.

(3) It has quality management institution or personnel suitable for the medicinal product distributed, and its legal representative, primary person in charge, person in charge of quality, etc., meet the prescribed conditions.

(4) It has a quality management system guaranteeing the quality of medicinal products, and an information management system satisfying the requirements for quality management and traceability, and satisfies the requirements of the quality management specifications for the distribution of medicinal products.

Article 11 For the establishment of a medicinal products distribution enterprise, after obtaining a business license, an application for a medicinal products distribution license shall be filed with and the following materials shall be submitted to the local medical products administrative department above the county level:

(1) The Application for a Medicinal Products Distribution License.

(2) The information of the quality management institution and relevant materials on the educational background and work experience of the primary person in charge, person in charge of quality, and person in charge of the quality management department.

(3) The qualification certificates of pharmacists or other pharmaceutical technicians and their employment documents.

(4) The materials related to the mode and scope of distributing medicinal products.

(5) The rules and regulations on quality management of medicinal products and the list of display, storage and other key facilities and equipment.

(6) The information on business premises, equipment, storage facilities and surrounding health environment, layout plans for business premises and warehouses, and materials related to property rights or use rights of houses.

(7) Other materials as prescribed in laws and regulations.

An applicant shall be responsible for the authenticity of all the contents of the application materials.

An applicant shall mark the trade secrets, information not disclosed, or confidential business information in the application materials, and indicate the basis according to the relevant rules of the state.

Article 12 After receiving an application for a medicinal products distribution license, the medical products administrative department shall handle it respectively according to the following circumstances:

(1) Where an application item is not subject to a medicinal products distribution license in accordance with the law, the applicant shall be notified of rejection immediately.

(2) Where an application item is not subject to the jurisdiction of the departments according to the law, a decision on rejecting the application shall be immediately made and the applicant shall be notified of applying to the relevant administrative department.

(3) Where there is any error that may be corrected on the spot in the application materials, the applicant shall be allowed to take corrective action on the spot.

(4) Where the application materials are incomplete or fail to satisfy the requirements for formal examination, a Notice of Supplementing and Correcting Materials shall be issued to the applicant on the spot or within five days, and the applicant shall be notified of all the contents to be supplemented and corrected at one time. Where it fails to notify the applicant within the prescribed time limit, it shall be deemed acceptance from the date of receiving the application documents.

(5) Where the application documents are complete and satisfy the requirements for formal examination, or the applicant has submitted all the supplementary documents as required, the application for a medicinal products distribution license shall be accepted.

A medical products administrative department accepting or rejecting an application for a medicinal products distribution license shall issue a Notice of Acceptance or Notice of Rejection to which the special seal of the department is affixed and on which the date is indicated.

Article 13 The medical products administrative department shall make a decision within 20 days from the date of acceptance of the application.

The medical products administrative department shall, in accordance with the quality management specifications for the distribution of medicinal products, the guiding principles for on-site inspection, the detailed inspection rules, and other relevant provisions, organize technical review of application materials and on-site inspection.

After technical review and on-site inspection, if the conditions are met, permission shall be granted, and a medicinal products distribution license shall be issued within five days from the date of making a licensing decision; and where the conditions are not met, a written decision on rejecting license shall be made, and the reasons shall be explained.

Where only retail activities of class-B non-prescription medicinal products are carried out, after the applicant submits the application materials and letter of commitment, licensing shall be granted, and the medicinal products distribution license shall be issued on the same day. Within three months from the date of making a licensing decision, the medical products administrative department shall organize technical review and on-site inspection; where it is found that the commitment is untrue, it shall order rectification within a prescribed time limit; and where the conditions are still not met after rectification, the medicinal products distribution license shall be revoked.

Article 14 The medical products administrative department shall publicize the conditions, procedures, and deadlines for applying for a medicinal products distribution license, the catalog of all materials to be submitted, and the format text of the application form on the website and at the office.

Article 15 The medical products administrative department shall disclose the results of the application for a medicinal products distribution license, and provide conditions to facilitate the applicant to inquire about the approval process.

Without consent of an applicant, the medical products administrative department, professional technical institution and its staff members shall not disclose any business secret, undisclosed information or confidential business information submitted by the applicant, unless as otherwise prescribed by law or when it involves national security or major social and public interests.

Article 16 The medical products administrative department shall make an announcement to the public and hold a hearing, where it deems that a medicinal products distribution license involves public interests.

Where a medicinal products distribution license directly involves the vital interest between an applicant and another party, the medical products administrative department shall, before making a decision on administrative licensing, notify the applicant and the interested party of their rights to requesting for holding a hearing.

Article 17 Divided into originals and photocopies, a medicinal products distribution license shall be valid for five years. A medicinal products distribution license shall be made uniformly by the National Medical Products Administration. The electronic and paper certificates of a medicinal products distribution license shall have the same legal force.

Article 18 A medicinal products distribution license shall specify the license number, enterprise name, unified social credit code, business address, legal representative, primary person in charge, person in charge of quality, business scope, business mode, warehouse address, license-issuing authority, issuance date, validity, and other items.

The enterprise name, unified social credit code, legal representative and other items shall be consistent with the relevant contents specified in the business license verified and issued by the market regulatory department.

Article 19 The items specified in a medicinal products distribution license are divided into licensing items and registration items.

License items refer to business address, business scope, business mode, and warehouse address.

The registered items refer to the enterprise name, unified social credit code, legal representative, primary person in charge, person in charge of quality, etc.

Article 20 The business scope of a medicinal product wholesale enterprise includes TCM decoction pieces, Chinese patent medicine, pharmaceutical chemicals, biological products, in vitro diagnostic reagents (medicinal products), narcotics, class-1 psychotropic substances, class-2 psychotropic substances, pharmaceutical precursor chemicals, toxic medicinal products for medical use, protein assimilation preparations, peptide hormones, etc. The verification of the business scope of narcotics, class-1 psychotropic substances, class-2 psychotropic substances, pharmaceutical precursor chemicals, toxic medicinal products for medical use, protein assimilation preparations, peptide hormones, etc. shall be governed by the relevant rules of the state.

Those who distribute medicinal products with special management requirements such as refrigeration and freezing shall indicate them in the business scope.

Article 21 To carry out medicinal product retail activities, the business category shall be approved and be specified in the business scope. Business categories are divided into prescription medicinal products, class-A non-prescription medicinal products, and class-B non-prescription medicinal products.

The business scope of medicinal product retail enterprises includes TCM decoction pieces, Chinese patent medicine, pharmaceutical chemicals, the second class psychotropic substances, blood products, cell therapy biological products and other biological products. The verification of the business scope of class-2 psychotropic substances, blood products, and cell therapy biological products shall be governed by the relevant rules of the state.

Those who distribute refrigerated and frozen medicinal products shall indicate them in the business scope.

The business scope of a medicinal products retail chain store shall not exceed the business scope of the headquarters of the medicinal products retail chain.

Article 22 Those who carry out radioactive medicinal products distribution activities shall apply for a radioactive medicinal products distribution license in accordance with the relevant rules of the state.

Article 23 To change the licensing items specified in a medicinal product production license, an application for alteration of the medicinal products distribution license shall be filed with the license-issuing authority. Without permission, no licensing matter shall be changed arbitrarily.

The license-issuing authority shall, within 15 days from the date of accepting an application for alteration, make a decision on approving or disapproving alteration.

A medicinal products retail enterprise that is acquired by the headquarters of another medicinal products retail chain shall undergo the formalities under the procedures for changing the medicinal products distribution license.

Article 24 Where the registered items specified in a medicinal products distribution license are changed, an application for handling registration of alteration of the medicinal products distribution license shall be filed with the license-issuing authority within 30 days from the date of ......