Another province medical network on July 17 - post, encourage large drug swallow peer!
Since the state council promulgated the further reform and improve the use of policy implementation plan for producing and distributing medicines ", large circulation medicine group day arrived on schedule. The provinces have a policy to encourage its bigger and stronger, and let go of, more and more big.
On July 14, shandong food drug administration issued "about further promote transformation and upgrading of medicine circulation industry innovation and development of opinion (draft)". Paving the way for the big batch, open the door, bridge, encourage more stronger, mercury, covering the shandong nook and cranny.
Break, create conditions to encourage big eat small
Encourage large medicine group, through mergers and restructuring, joint development, bigger and stronger. In the process of merger and acquisition of small and medium-sized medicine group, involving intercity relocation, enterprise restructuring, the storage and distribution facilities equipments is not lower than the original set up conditions.
In the merger and reorganization, if the business address, quality management system unchanged, according to permit changes to deal with. To deal with variation of the pharmaceutical trade license may continue to operate, not out of business.
Big batch of long-distance business, need not set a warehouse
Encourage large medicine group of break the regional boundaries, centralized and unified distribution. Pharmaceutical wholesale and retail chain enterprise group division is set in across regions in the province, not a warehouse, entrust the group belong to drug distribution center or pharmaceutical wholesale enterprises unified distribution.
To encourage the construction of national, regional medical logistics park, and distribution center, support drug across regions distribution, modern logistics enterprises expand third-party pharmaceutical logistics business.
For large batch, tailored "two votes"
Allow drug companies, internal medicine group group, allocate drugs directly. Allow drug companies and set up the only sale this enterprise product management company, sharing their finished goods warehouse; Allow drug group corp. and its set up wholly owned or holding pharmaceutical wholesale enterprises in shandong province, on the basis of unified purchase, unified sales of make out an invoice, trial of synergy will be carried out.
Combined with shandong "two votes" scenario, the "current group internal transfers not one vote", big batch of benefits.
At the same time, encourage circulation enterprises integration of wholesale, retail business. Profile in patients with slow disease medication for a long time, record the patient medical case information, need to buy drugs, and the detailed information, by remaining in the over-the-counter sales for the first time.
Bureau of shandong province and the delegate, mutual supervision
Drug storage and distribution of the delegate is the first responsible drug quality and safety. Clients should strengthen to the entrusted party to perform the GSP rules and performance of the contract management, at least a year to entrusted to undertake a comprehensive quality audit, the audit record should keep file for future reference.
ShengJu fly in the organization of all kinds of inspection, random inspection, storage, and distribution business entrusted to intercity in enterprises as key inspection scope.
620 drugs, or into the "warring states period"
According to the administration of data in 2016, shandong has 620 pharmaceutical wholesale enterprises, encourage merger and acquisition policy under the guidance of medium and small batch or show, to change their ways; May not from, animal fight to the last.
Objectively speaking, big business is strong, however, also must not ignore socially and tenacious vitality. If the "paper", shandong medicine group will present situation, the blue parker will be further tracing investigation.
Shandong food drug administration also said that the industry such as have different opinions, please in July 24, 2017, through emails, letters and faxes, put forward opinions and Suggestions to shandong bureau. (see the appendix of furniture list for detail)
P.S. on further promote transformation and upgrading of medicine circulation industry innovation and development of opinion (draft)
Municipal food and drug administration:
For the implementation of the provincial party committee, provincial government to speed up the old and the new kinetic energy conversion, the strategic deployment of strong economic and cultural province, optimize the allocation of resources, promote drug cross-regional, cross ownership merger and reorganization of enterprises and the construction of scientific, reasonable, efficient and smooth medicine logistics system, enhance the level of drug circulation scale, intensive and ensure the quality of circulation and drug safety, according to the general office of the state council on further reform and improve the pharmaceutical production circulation use policy several opinions (countries do hair [2017] no. 13), the ministry of commerce, the national medicine circulation industry development plan (2016-2020) and other documents required, regarding further promote transformation and upgrading of medicine circulation industry in our province, innovation and development matters related to notice the following:
A, promote the development of medicine circulation enterprise merger restructuring, joint
Encourage pharmaceutical wholesale enterprises with drug modern logistics conditions through mergers and restructuring, joint development, promote the standardization, scale, develop large modern medicine circulation backbone enterprises. For drug modern logistics enterprise merger and acquisition of pharmaceutical wholesale enterprises, existing in the intercity relocation, enterprise restructuring, the storage and distribution facilities equipments is not lower than the original opening conditions. Encourage for modern logistics enterprise group upgrading of merger and acquisition of enterprises, involved in grassroots, rural drug distribution services.
Pharmaceutical wholesale, retail chain enterprises in the merger and reorganization, such as business address, quality management system has not changed, according to the license changes, deal with the pharmaceutical trade license changes don't pause during the original business, but mergers and acquisitions and mergers and acquisitions both sides must perfect drug quality assurance agreement, clear the responsibility main body, realize the source traceability, to find out, to ensure the quality of medicines.
Second, the support to carry out the drug third-party logistics business
Support for pharmaceutical logistics enterprises in the third party drug logistics business, allowing legitimate drug-producing enterprises, drug-handling enterprises store pharmaceutical distribution business entrusted to have drug modern logistics requirements of pharmaceutical wholesale enterprises in our province. On the basis of the early stage of the pilot, the opening of entrusted subject and scope of the restrictions, can entrust the subject according to their own needs, according to the varieties or distribution area, special management of medicines and chemical reagents, diagnostic reagents specializes in enterprise shall entrust distribution. If no special reason, drug wholesale, retail chain enterprises in principle only has commissioned a drug modern logistics conditions of pharmaceutical wholesale enterprises to storage and distribution.
Encourage large pharmaceutical trading enterprises break the regional boundaries, centralized and unified distribution. Pharmaceutical wholesale and retail chain enterprise group in across regions in the province set up the retail chain division, not a warehouse, and entrusted the group belong to drug distribution center or pharmaceutical wholesale enterprises unified distribution.
Three, encourage drug-handling enterprise cross-regional distribution
To encourage the construction of national, regional medical logistics park, and distribution center, support drug across regions distribution, modern logistics enterprises expand third-party pharmaceutical logistics business. Meet pharmaceutical logistics conditions of pharmaceutical wholesale enterprises group, set up the company regional drug distribution agencies intercity adapted its scale and conditions and regional distribution tasks under the premise of according to the relevant issues about the newly established drug wholesaler notice (lu food drug safety hair [2007] no. 8), at the same time must be strictly implemented the GSP relevant requirements and accept earthly food and drug regulatory oversight.
Fourth, explore new model drug circulation
Advance medicine circulation enterprises, warehousing and transport resources effective integration, exploration of more efficient, more secure, more professional pharmaceutical logistics distribution mode, reduce the drug circulation cost, and quality risk. Allow the pharmaceutical wholesale enterprises group or pharmaceutical producing enterprises set up business company according to the confirmed by the ShengJu pilot program, on the premise of computer integration, production, management of drugs within the group to carry out the drug straight adjustable pilot; Allow the pharmaceutical production enterprise set up with only sales this enterprise product management companies share the finished goods warehouse; Allow for modern logistics of pharmaceutical wholesale enterprises group and in the province set up wholly owned or holding pharmaceutical wholesale enterprises according to the confirmed by the ShengJu pilot program, the computer integrated management, unified quality vertical management, basic data management, purchasing management, logistics management, unified sales, on the basis of review of make out an invoice management, conduct of the pilot.
Encourage the drug circulation enterprise integration of wholesale and retail business. To long-term use of fixed drug control and treatment of chronic diseases with the sale of prescription drugs, can establish archives for patient records patient medication situation, need to buy drug information and detailed information, buyers by retained the prescription of sales for the first time, and save the complete sales account for future reference.
Fifth, actively promoting "Internet + medicine circulation"
In order to satisfy the demands of the crowd safety and convenient medication as the center, positive play "Internet + medicine circulation" in reducing transaction costs, improve the efficiency of circulation, and promote information disclosure, to break the monopoly advantage and function. Guide "Internet + medicine circulation" specification development, support the medicine circulation enterprises and Internet companies to strengthen cooperation and promote the development of online fusion, cultivate new formats. Standard retail pharmacies Internet retail services, to promote "the net book store take", "net book store send" new distribution way, encourage Internet holder of pharmaceutical trading enterprises provide delivery service for online drug trade. Support conditional region based on the existing information system, to carry out the pharmacist prescription audit, guide for the rational use of drugs and other online pharmacy practice. Pharmaceutical wholesale enterprises in the province with the group's pharmaceutical wholesale enterprises or terminal customers (retail pharmacies, use the unit) in the province to carry out the drug in the province (except for special medicines), to ensure drug quality and safety, traceability, can choose to transfer drug quality records in electronic form.
Six, implement enterprise's main body responsibility
Drug storage and distribution of the two sides should strictly carry out commissioned and commissioned the pharmaceutical administration law and other laws and regulations, set up information platform of electronic data interchange, for the connection of computer remote information, electronic data exchange and synchronization, and can achieve resource sharing, data sharing, communication and traceability.
Drug storage and distribution of the delegate is the first responsible drug quality and safety. Clients should strengthen to the entrusted party to perform the GSP rules and performance of the contract management, at least a year to entrusted to undertake a comprehensive quality audit, the audit record should keep file for future reference. Discovered in the audit entrusted party such as a serious breach of GSP rules or other illegal situation, should terminate entrusted storage and distribution agreement, and timely report ShengJu and ground level above the metro. Drug storage and distribution of the entrusted party shall strictly in accordance with the laws and regulations requirements within the scope entrusted drug, storage, distribution and to ensure that the drug is entrusted to the receipt, acceptance, storage, maintenance, outbound, shipping, returns, recalls and process management and control. Assume many of the entrusted business, entrusted party shall ensure that all clients business data and record the true, complete, accurate, and mutual interference and confusion, to ensure effective traceability in the whole process of the drug information.
Seven, strengthen the matter later regulation
, according to the principle of territorial management, drug store distribution, entrusted party for enterprises in the province, the principal or the agent for enterprises in the province, respectively by the entrusting party, entrusted party under the home city and city food and drug regulatory departments shall be responsible for the daily supervision, the local food and drug regulatory authority should take effective measures to strengthen the corresponding enterprise drug quality, channel and storage and transportation conditions, and so on and so forth regulation, when necessary, can be extended to the behavior of the entrusted party, the client inspection, earnestly perform supervisory duties. ShengJu fly in the organization of all kinds of inspection, random inspection, storage, and distribution business entrusted to intercity in enterprises as key inspection scope.
Administration of countries such as in medicine circulation regulation reform of a new policy, those provisions shall be followed. This notification content are inconsistent with ShengJu existing documents, this circular shall prevail.
On July 24, 2017, please put forward opinions and Suggestions through the following three ways:
A, the opinions and Suggestions to: zongyucong@sdfda.gov.cn
Second, to deliver the opinions and Suggestions to: the jing shi road of jinan city road no. 16122 (250014) shandong province food and drug administration drug market supervision department, and on the envelope marked "" about further promote transformation and upgrading of medicine circulation industry innovation and development of circular feedback with the words".
Three, fax the opinions and Suggestions to: 0531-88562318 |
