beijing will welcome "new regulations" for opening pharmacies: emphasizing drug traceability, and some requirements may be relaxed
2024-09-14
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the beijing municipal drug administration recently solicited public opinions on the newly revised "beijing provisions on opening drug retail enterprises (draft for comments)" (hereinafter referred to as the "draft for comments"), and the deadline for soliciting opinions is october 5. the "draft for comments" is a combination of leniency and strictness. it mentions the drug traceability system many times and emphasizes that the flow of drugs can be traced; it formulates many detailed rules for retail chain headquarters, emphasizing that the headquarters shall not sell drugs directly to individuals; for pharmacies that only sell class b over-the-counter drugs, it adjusts the requirements for pharmacists and the minimum area for drug use in business premises.
repeatedly emphasized that drugs can be traced
the "beijing interim regulations on the establishment of pharmaceutical retail enterprises (trial)", which was officially implemented on january 1, 2018, was formulated at an early time and is no longer in line with the needs of superior laws and the high-quality development of beijing's pharmaceutical distribution industry. the beijing municipal drug administration stated that it is necessary to conduct a comprehensive revision.
drug traceability will be an important means to combat "drug reflux". in recent years, cases of "drug reflux" have occurred frequently. the national medical insurance administration has exposed "drug reflux" cases on its wechat public account many times this year. compared with the old version of the regulations, which did not mention drug traceability, the "draft for comments" mentioned "traceability" 24 times, involving 7 provisions. in the general provisions, it is clearly stated that drug retail enterprises should abide by the unified drug traceability standards and specifications formulated by the drug supervision and management department, establish and implement a drug traceability system, provide traceability information in accordance with regulations, and ensure that drugs are traceable.
in the detailed rules, the "draft for comments" requires pharmaceutical retailers to establish computer systems that have the function of connecting data with the drug traceability system to ensure timely and accurate upload of drug purchase, sales, storage and other data, and the computer information management system of the pharmaceutical retail chain headquarters should be able to connect with the beijing food and drug administration's drug traceability system and accept remote supervision by the drug regulatory authorities. stores of pharmaceutical retail chain enterprises should update the information of allocated drugs in the computer management system to ensure that the flow of drugs can be traced, and emphasize that "the whole process can be traced."
chain headquarters are not allowed to sell drugs directly to individuals
as the chain of drug stores increases, higher requirements are also put forward for drug retail chain headquarters. compared with the old version of the regulations, which only mentioned drug retail chain headquarters four times, the "draft for comments" mentioned "chain headquarters" 28 times, and two of the general provisions involved chain headquarters, emphasizing that drug retail chain headquarters should establish and improve quality management systems, unify corporate logos, rules and regulations, computer systems, personnel training, procurement and distribution, bill management, pharmaceutical service standards and specifications, etc., and perform management responsibilities for the business activities of affiliated retail stores. at the same time, it is clear that the beijing municipal drug administration guides the supervision and management of retail headquarters, and each branch is responsible for the supervision and management of drug retail chain headquarters within its jurisdiction, and is responsible for establishing and improving the supervision and management files of drug retail chain headquarters.
in the specific provisions, a series of new regulations are also added for chain headquarters, clarifying the positioning of chain headquarters and putting forward detailed requirements for the scale of business premises, distribution, quality management system construction, etc. of chain headquarters. at the same time, it is emphasized that drug retail chain enterprises engaged in online drug retail should use stores as the main sales entity, and the headquarters shall not sell drugs directly to individuals.
the headquarters of a drug retail chain should have business premises and distribution centers (warehouses) that are appropriate to the types and scale of its business; if a distribution center (warehouse) is set up, the building area shall not be less than 200 square meters. the chain headquarters shall establish and improve the quality management system, establish a computer system that meets the requirements of drug operation and quality traceability, covers the headquarters, distribution centers (including entrusted storage and distribution) and stores, and control and record all aspects of drug operation and the entire process of quality management in real time to ensure that the entire process of drug operation is traceable.
requirements for class b over-the-counter pharmacies to be relaxed
in terms of the staffing of licensed pharmacists, the "draft for comments" is slightly looser than the old version.
the old version of the regulations required that pharmaceutical retailers operating prescription drugs and class a over-the-counter drugs should be equipped with at least one licensed pharmacist and two pharmaceutical technicians with a professional title equivalent to pharmacist or above. the draft for comments, however, requires "licensed pharmacists or other pharmaceutical technicians who have been qualified in accordance with the law and are suitable for the scale and variety of business operations" without emphasizing the specific number.
as more and more pharmacies can apply to operate biopharmaceuticals, the "draft for comments" specifically proposes that pharmaceutical retail companies operating cell therapy biological products should be equipped with at least one practicing pharmacist with a bachelor's degree or above in clinical medicine, preventive medicine, immunology, microbiology and other majors, and must have undergone training and assessment by the relevant product marketing license holder.
the draft for comments also has some changes for pharmacies that only sell class b over-the-counter drugs. for example, the old version required "at least one pharmacy technician with a title equivalent to or above that can be employed"; the draft for comments is more relaxed, saying "can be equipped with drug sales personnel who have passed the assessment organized by the municipal drug supervision and administration department." the draft for comments also relaxes the requirements for the drug use area of the business premises, from "not less than 20 square meters" stipulated in the old version to "not less than 10 square meters."
in addition, the draft for comments mentions that for those who only engage in the retail of class b over-the-counter drugs, the approval will be subject to informed commitment. after the applicant submits the application materials and the letter of commitment, if they meet the conditions, the license will be granted and the drug business license will be issued on the same day. within three months from the date of the licensing decision, the drug supervision and administration department will organize a technical review and on-site inspection. if it is found that the commitment is untrue, it will be ordered to rectify within a time limit. if it still does not meet the conditions after rectification, the drug business license will be revoked, which also reflects the attitude of "combining leniency and strictness".
beijing news reporter wang kala
proofread by mu xiangtong
