Medical network - on January 13, on January 9, who in shandong province development planning commission issued the measures for the administration of the drug centralized purchasing bad records in shandong province.
This is who planning commission of shandong province for the original "the shandong province basic drug centralized purchasing record management approach (trial)" (hereinafter referred to as the "old ways") after revised, the new file.
On January 1, 2015, the shandong province basic drug centralized purchasing record management approach (trial) "start, but is valid only until December 31, 2016, also only for basic drugs, medicines and other high value material reference implementation.
The new drug centralized purchasing record management method "in shandong province (hereinafter referred to as the" new way "), shall become effective as of January 2017, will expire on December 31, 2019.
As the name implies, compared with the old way, the new way to coverage by extended to all drugs, basic drugs aim is in order to further improve the system of record management and market repel. The new method is put forward, the high value medical consumables production management enterprise's poor record management with reference to the way to perform.
In addition, the new method and old way to commit any act in the enterprise will be included in the record, will be what kind of punishment, and no difference.
This means that health development planning commission of shandong province in the pharmaceutical industry enterprises oriented record management, has now formally by its essential medicines areas extend to all drugs, basic drugs outside of other drugs into must also implement enforced by reference. The difference between the two words, but also make the enterprise faced with the regulatory environment, optional soured by the government will be options.
Not surprisingly, the next step, the high value medical consumables will also be performed by the reference record management, record management into must perform. Equally unsurprisingly, drug production, management companies shouldn't entities behavior, also applicable to high-value consumables enterprises were totally.
In shandong province, from the adverse drug centralized purchasing records management method "to find the answer, see the high-value consumables enterprises what behavior will be included in the record, to meet what kind of punishment, the enterprise should be how to take?
The blue parker instrument notice, shandong record management is strict, both bad record, commercial bribery has generally bad record.
Enterprise in 4 kinds of circumstances, will be disqualified from the centralized purchasing of products, and 2 years was kicked out of the public medical institutions in shandong province thoroughly. These situations including bribery, fraud, cheating the bid, malicious "complaints and supply fakes, detailed in the shandong province adverse drug centralized purchasing records management measures for article 5, article 6 and article 8, paragraph 1.
Enterprise in 11 cases, face cancel product qualification of centralized purchasing, and 2 years not to participate in provincial online in punishment. These situations including malicious bid low, not timely delivery, the winning product prices, supply the unqualified products without authorization, detailed in the shandong province adverse drug centralized purchasing records management method "in the second paragraph of article 7 and article 8.
In provincial in be online at the county level and above, the main way of purchasing of public hospital must, not to participate in provincial in online, is actually not far from kicked out of the public medical institutions market.
In addition, there are other bad situation for enterprises of processing, such as being revoked certificates revoked certificate of GMP, GSP... And, in the enterprise merger and acquisition and other special circumstances, the provisions of the record to do, and so on.
So "suspended" strictly, high-value consumables enterprises must attach great importance to, early learning, adapting to ahead of time, find the solution in advance.
Attachment: the shandong province adverse drug centralized purchasing records management method"
Article 1 with a view to regulating the behavior of medical institutions in our province drug centralized purchasing, maintenance pharmaceutical sales order, ensuring the supply of drugs in clinical, according to the national health and family planning commission "on establishing a pharmaceutical sales field of the regulation of commercial bribery bad record" (the guard hair [2013] no. 50) of legal system and the general office of the state council "about perfecting public hospital drug centralized procurement guidelines" (countries do hair [2015] no. 7), the general office of the people's government of shandong province on the printing of the grassroots health institutions in shandong province basic drug centralized purchasing implementation method (try out) > notice (ZhengBan hair [2010] no. 76), "about carrying out the hair [2013] no. 14 files to cement improve the system of basic drugs and grass-roots operation mechanism of opinions" (lu ZhengBan hair [2014] 31), "about carrying out the hair [2015] no. 7 files perfect public hospital drug centralized purchasing work implementation opinion" (lu ZhengBan hair [2015] 47) and other documents spirit, are formulated.
Article 2 these measures apply to participate in shandong provincial drug centralized purchasing of medical institutions and drug production enterprise and the parties.
Referred to in article 3 hereof record including pharmaceutical sales field of commercial bribery record (hereinafter referred to as the commercial bribery record) and general bad record.
Article 4, and recognized by law enforcement authority in the purchase and marketing activities of pharmaceutical, exists to the medical and health institutions in the province, the drug centralized procurement institutions and their staff implementation of commercial bribery, by the provincial drug centralized purchasing department in charge of the related production and operation enterprises and their partners on pharmaceutical sales field of commercial bribery bad record, and according to the national health and family planning commission on establishing the regulation of commercial bribery bad record "pharmaceutical sales field (countries who hair [2013] no. 50) of legal system of the relevant provisions.
Article 5. All the production and operation of the pharmaceuticals listed in the commercial bribery record companies, disqualified from centralized purchasing of all of the products in the enterprise net; Provincial drug centralized purchasing agency within two years from the date of treatment decision not to accept the application for any product online centralized purchasing. Within two years the public medical institutions shall not purchase any form of the drug, the original termination of contract of purchase and sale.
Article 6 of the pharmaceutical production enterprise has one of the following ACTS, included in the general bad record and posted on the Internet, cancel the qualification of centralized purchasing of all of the products in the enterprise net, provincial drug centralized purchasing agency released since two years from the date of not accepting the application for any product of centralized purchasing online. Within two years the public medical institutions shall not purchase any form of its products, the original termination of contract of purchase and sale.
(a) in the centralized purchasing in the process of providing false documents, or to any other false and deceptive method for winning.
(2) the malicious "complaints, disrupt the normal order of centralized purchasing.
Article 7 the pharmaceutical production enterprise has one of the following ACTS, included in the general bad record and published on the Internet. An illegal warned at a time, and shall be ordered to make rectification within a time limit. Late do not change or illegal again, cancel the corresponding products online qualification of centralized purchasing, provincial drug centralized purchasing agency within two years from the date of announced the decision not to accept any products online centralized purchasing application.
(a) the bid after refused to sign the purchase and sale contract or clean procurement contract;
(2) to increase in the price of the winning products without authorization or in disguised forms;
(3) to below cost price malicious bidding disrupt the market order;
(4) to any other than winning products to replace the winning products for distribution or tie-in sales;
(5) not timely delivery as stipulated in the contract the winning products, the arrival rate is lower than 80%, and the adverse consequences;
(6) medical institutions reflect supply not in time, lead to clinical medicine shortage, if the circumstances are relatively serious;
(7) confirmed by the medical and health institutions of the distribution of the drug specifications, packing and the winning of the specifications of the drug, inconsistent refused to agree to replace;
(8) in emergency medicine, because the quantity is little, the amount is small and refused to delivery, affect clinical use;
(9) in the purchase cycle without justified reason to apply for to cancel the bidding qualification;
(10) in violation of the provisions of other laws and regulations.
Article 8 goods pharmaceutical production enterprise has one of the following ACTS, in generally poor record and published on the Internet.
(a) after the companies won the bid, supply products in the purchase cycle is identified as the fake drugs, cancel the qualification of production enterprises of all products online centralized purchasing, provincial drug centralized purchasing agency within two years from the date of announced the decision not to accept any of its products online centralized purchasing application. Within two years the public medical institutions shall not purchase any form of its products, the original termination of contract of purchase and sale.
(2) companies won the bid, supply products in the purchase cycle by the pharmaceutical supervisory and administrative department at the provincial level and above food quality announcement for the unqualified products, violations warned at a time, and shall be ordered to make rectification within a time limit. Late do not change or illegal again, cancel the corresponding products online qualification of centralized purchasing, provincial drug centralized purchasing agency within two years from the date of announced the decision not to accept any products online centralized purchasing application.
(3) the purchasing cycle production license has been revoked by the administrative departments of food and drug, from the date of revocation, cancellation of the corresponding products of centralized purchasing online.
(4) the purchasing cycle registered by the food and drug supervision and administration department to cancel the approval documents, from the date of revocation, cancellation of the corresponding products of centralized purchasing online.
(5) the purchasing cycle drug GMP (GMP refers to "drug production quality management norms") certificate by the food and drug supervision and administration department to withdraw, from the date of revocation, cancellation of enterprises of all products within the scope of the drug GMP certification certificate of qualification of centralized purchasing online. To regain after drug GMP certificate, be disqualified from online centralized purchasing products must apply again, and the related formalities.
(6) procurement cycle GSP (GSP refers to "the drugs management quality management norms") certificate by the food and drug supervision and administration department to withdraw, from the date of revocation, cancellation of the qualification of enterprise centralized purchasing online distribution. To regain the GSP certification, must go through formalities for a centralized distribution of related.
Article 9 of the parent company was included in the record or commercial bribery generally bad record, its subsidiary, with independent legal personality does not need to assume corresponding responsibility together with the parent company; An independent legal entity, a subsidiary of commercial bribery was placed on the record or general bad record, the parent company will not bear corresponding responsibility.
Article 10 commercial bribery in bad record or general record the production and operation of the legal representative of the enterprise is the poor record of those responsible.
Article 11 on commercial bribery record or general record should be held responsible for the production and operation of enterprises in the decision was registered after the new pharmaceutical production enterprise, and as the legal representative of the new company, new companies are also included in the record or commercial bribery generally bad record, in dealing with, within the time limit in accordance with the remaining time to continue processing.
Article 12 on the record or commercial bribery generally poor record in dealing with the production and operation of enterprises within the time limit for the name change, the new company also included in the record or commercial bribery generally bad record, processing time limit in accordance with the remaining time continue processing.
Article 13 of the commercial bribery in bad record or general record by other production and business operation of the enterprise merger or acquisition, the original enterprise main body, its rights and obligations by merger or acquisition of companies to undertake, the merger or acquisition of companies listed in the record or commercial bribery generally bad record, treatment time, in accordance with the rest of the continuation.
Article 14 provincial drug centralized purchasing agency is responsible for dynamic monitoring the winning pharmaceutical production enterprise, every quarter through the provincial drug centralized procurement network situation of the winning products procurement and distribution.
Article 15 the provincial drug centralized purchasing authorities under the state council in conjunction with the relevant departments to report received bad record, relevant situation reflects or online dynamic monitoring information summary analysis, for alleged violations of the enterprises to carry out investigation to verify.
Article 16 to pharmaceutical production enterprise in violation of the regulations of the above, before on record and give the corresponding processing, by provincial drug centralized purchasing agency to inform the parties involved, and to give the parties to appeal period of five working days. The appeal period without complaint or objection is not approved, released by the provincial drug centralized procurement network processing results.
Products of enterprises in violation of article 17 repel and later by the market, the provincial departments of drug centralized purchasing according to the relevant provisions of the relevant purchasing files available to other enterprises in turn.
Article 18 high value medical consumables production management enterprise's poor record management present measures implementation.
Article 19 hereof by drug centralized purchasing department is responsible for the interpretation of shandong province.
Article 20 the measures from the date of release, is valid until December 31, 2019. |
