The new regulations will affect all drugstores completely!

Source: sepiland - pharmacy Manager ▍ editor: yuanashley What application materials do you need to open a drugstore? How long does the audit take? Does the enterprise legal person, the person in charge of quality, etc require to be a licensed pharmacist? When purchasing drugs, how long does the supplier's information and sales voucher need to be kept? To sell prescription drugs, in addition to practicing pharmacists on duty, what other conditions should drugstores meet? On December 10, the State Administration of Market Supervision issued a document to solicit public opinions on the measures for the supervision and administration of drug production (Draft for comments) and the measures for the supervision and administration of drug trade (Draft for comments) The deadline for feedback is December 20, 2019 Among them, the measures for the supervision and administration of drug trade (Draft for comments) (hereinafter referred to as the measures) put forward relevant requirements for the business license, application and audit matters, sales scope verification and other contents of retail enterprises, which completely affected all drugstores According to Article 7 [license conditions for headquarters of retail chain enterprises], the headquarters of enterprises engaged in drug retail chain operations shall meet the following conditions: Before that, Anhui, Xinjiang, Hubei and other places had issued documents to put forward relevant regulations on whether the legal person and the person in charge of quality must be a licensed pharmacist in the process of opening pharmacies Some regions stipulate that for newly established drug retail chain enterprises, the headquarters may designate a manager with the qualification of licensed pharmacist to be the enterprise head of the subordinate stores, or the licensed pharmacist registered in the subordinate stores may be the head of the store In other words, all chain stores do not need to have a licensed pharmacist as the person in charge of each store, only one licensed pharmacist can be appointed Some regulations require that: the legal representative and the main person in charge of the headquarters of a drug retail chain enterprise must bear legal responsibility for the drug business activities of its stores in accordance with the law, and no longer require that the person in charge of the stores of the chain enterprise must be a licensed pharmacist It is also mentioned in local regulations that chain stores applying for remote examination may not be equipped with licensed pharmacists, and each store shall be equipped with at least one pharmacist or above qualified pharmacists as the quality director In a word, in the local regulations, there are appropriate "Relaxation" policies for the requirements of enterprise legal person and quality director, which also brings "confusion" to a group of licensed pharmacists Is the market demand of licensed pharmacists decreasing? Others are at a loss about whether to continue to prepare for the examination of practicing pharmacists However, the regulations on the conditions of enterprise legal person and quality director in the measures can explain to a certain extent that the first identity of the legal person and quality director of drugstores is to recommend licensed pharmacists first Secondly, in the long run, with the introduction of the new version of the drug administration law, the requirements for the level of drug quality audit and other business matters are gradually improving, and licensed pharmacists are still "popular" in the industry At the same time, the measures simplified the procedures for the establishment of pharmaceutical trading enterprises, cancelled the provisions on preparation approval and operation quality management certification, further reduced the approval time, and reduced the overall approval time of newly established pharmaceutical trading enterprises by nearly 50% When submitting the application materials, the enterprise can check the business license and other materials through the Internet; when purchasing and selling drugs, the enterprise can review and retain the enterprise qualification, variety qualification, purchase and sale certificate and other electronic materials According to Article 10, the establishment of drug retail enterprises, headquarters of drug retail chain enterprises and drug wholesale enterprises shall submit the following materials to the drug regulatory authorities of the city, county level or province, autonomous region or municipality directly under the central government where the enterprise is located in accordance with the administrative authority: In addition, according to Article 12, the drug regulatory department shall review the application materials within 30 working days from the date of accepting the application, and organize on-site inspection according to the inspection rules Upon examination of materials and on-site inspection, if the conditions are met, the approval shall be granted, and the drug trade license shall be issued within 5 working days from the date of making the approval decision; if the conditions are not met, the applicant shall be notified in writing and the reasons shall be explained, and the applicant shall be informed of the right to apply for administrative reconsideration or file administrative litigation according to law The time of on-site inspection and enterprise rectification shall not be included in the time limit of approval It can be said that it will be more convenient to open drugstores in the context of the national policy of "separation of license and license" In view of the situation that the purchase and sale management of drugstores is not standardized and the phenomenon of "back flow drugs" is high in the daily inspection, the measures also put forward relevant management rules According to the contents of Articles 31 to 35, the following conditions shall be met in the purchase and sale of drugs in drugstores: All the above materials shall be stamped with the official seal of the enterprise, and the electronic version confirmed through network verification, electronic signature, etc shall have the same effect.