Medical network on April 19 - accompanied by "two votes", a new round of surge flow regulation! More than half a China has started to hunt down!
▍ shanxi open grab, 23 drug GSP certificate be collected and removed
On April 18, shanxi food drug administration announced that closed from 23 drug GSP certificate. Notice said the medicine circulation field in the whole province intercity cross check found, xinzhou pharmaceutical (group) co., LTD. NingWu branch and so on four pharmaceutical wholesale enterprises (drug retail chain headquarters) a serious breach of regulations, decided to revoke the GSP certificate.
Also found that datong medicinal materials co., LTD and other 19 pharmaceutical wholesale enterprises (drug retail chain headquarters) in violation of relevant regulations, decided to withdraw the GSP certificate. (see the appendix of furniture list for detail)
On March 3, however, in 2017, shanxi printing "in 2017, the provincial food and drug supervision and administration work key point, has said: comprehensive, using means of administration, technology, forensic internal external multi-sectoral linkage, the key difficulty, as heavy-handed regulation. Will arrange in the province within the scope of centralized cross-regional flight check, cover the province's 119 counties (city, area), find out the quality and safety of drug circulation problems, investigate a batch of illegal case.
To hunt down and up, 23 drug thunder falls, fast, accurate and strict.
▍ 13 provinces began to large area of scrutiny, with a focus on the drug, the drug group of companies
In fact, most Chinese have begun to flow regulation, comb through the blue parker found that existing in Inner Mongolia, jilin, jiangsu, anhui, fujian, jiangxi, hubei, hunan, guangxi, sichuan, gansu, shaanxi, shanxi a total of 13 provinces/autonomous regions, and in March and April, concentrated released the circulation corrective plan.
It is important to note that the renovation project of center of gravity, besides callings, tickets, etc, several provinces have made it clear that for the implementation of the "two votes", to provide protection. Eliminate began a new round of circulation enterprises by 10000 to 3, should or goal.
The following are excerpts from the provincial food drug administration of the relevant documents.
▍ Inner Mongolia: a six-month rectification
On March 24, 2017, issued the implementation scheme of rectification of pharmaceutical wholesale enterprises in 2017 and 2017 pharmaceutical retail scheme for rectification notice. For batch and retail chain (headquarters), to carry out a six-month rectification.
Of pharmaceutical wholesale enterprises: one is for 2016 rectification of problems found in the "look back", check whether the enterprise is the rectification in place as required; 2 it is to cooperate with the implementation of the policy of "two votes", the key regulation without a licence, affiliated to go vote, zhang ticket fraud data inconsistencies, such as illegal business behavior; 3 it is required by the pharmaceutical cold chain storage regulation is not strictly enforce the illegal management behavior; Four is for traditional Chinese medicine, Chinese medicine yinpian, and other varieties of marketing channels at high risk of key inspection.
The pharmaceutical retail chain enterprises (headquarters) : one is the problem on the remote party system doesn't work; The second is regulation chain stores illegal mining; 3 it is licensed pharmacists "hang card" behavior.
Enterprise audits (1 April - 30), au city bureau inspection (May 1 - June 30), enterprise reform (July 1-30), autonomous region bureau of supervision spot (August 1-31), summarizes the acceptance (September 1-30).
▍ jilin: crackdown on the affiliated to go vote, high pressure on Chinese medicine yinpian operating companies
On April 6, 2017, jilin pharmaceutical circulation supervision meeting.
Meeting requirements, in 2017 the province's medicine circulation regulation work of pharmaceutical wholesale enterprises to carry out the renovation, the key to crack down on unlicensed operation and attached ticket, ticket bill payment for goods do not agree, such outstanding problems as data fraud; For traditional Chinese medicine, Chinese medicine yinpian enterprise keep high pressure situation. For pharmaceutical trading enterprises and unit using flight inspections; Belong to illegal problem is investigated according to law and exposure, found a, processing a, deter a batch, zero tolerance.
Key check whether there is a rental enterprise qualification or accept the affiliated business behavior, attention only walking ticket without actual goods flow behavior of make out an invoice, and purchase and sale qualification file information is not complete or not true, way above and beyond management problems.
▍ : jiangsu bat medicine circulation market
On March 21, 2017, medicine circulation supervision work conference in jiangsu province.
In 2017 to focus on the following several aspects work: a focus on outstanding problems, keep medicine circulation market regulation and high pressure situation. Secondly, to strengthen policy research, fully implement the medicine circulation system reform. Third, strict standard system, promote licensing and certification management level. Four basic to consolidate, everyday supervision and improve the results.
▍ anhui: high density for the whole year fly medicine group
Released on March 8th, 2017, anhui province in 2017 drug circulation flight inspection work plan.
Year of pharmaceutical wholesale enterprises flight check coverage of no less than 15%, flight check of the vaccine distribution enterprise coverage rate reached 100%. Focusing on:
1. The pharmaceutical wholesale enterprises affiliated to go vote of recovery, illegal drugs, special drugs compound preparations, cold chain drug management, personnel management, storage conditions and site management, inspection and warehouse management, transportation management, data authenticity, integrity, execution, and so on and so forth.
2. The vaccine distribution enterprise focusing on the vaccine temperature and humidity record in the process of storage and transportation, and extend upstream and downstream check;
3. The pharmaceutical retail enterprise focusing on illegally recycled drugs and beyond (way) to operate, licensed pharmacists on-the-job, purchase and marketing instrument management, the function of computer system, drug sales management (focusing on prescription drugs, including special drug compound preparations, etc.), the provisions of the state banned the sale drug enforcement, etc.;
▍ fujian: will check three kinds of medicine group of companies
Held on March 13, 2017, fujian province medicine circulation supervision work conference in 2017. Deputy inspector He Zhenming ShengJu stressed:
One will continue to keep high pressure situation, to carry out the public "" double random flight inspection, rectification, key check, do fight, bat, strict controls.
Second to evaluation for high risk, high risk of enterprises "flight check" included in the current year's respondents; Do it for a new start of enterprises must check report, enterprise must, had gathered adverse reactions and checking the quality problem such as unqualified enterprises must check and will;
Third, we need to check the unqualified varieties and the regulation of the business enterprise, be traced back to each batch unqualified varieties, ensure that spark legal sources.
▍ jiangxi: fly check 60 times throughout the year, continuous flow problems
On April 7, issued the 2017 jiangxi medicine circulation regulation work key point of the notice.
ShengJu arrange flight check 60 times in 2017, with cold-chain drugs, such as hemp compound preparations containing special control drugs and have bad behavior records and reports, complaints and drug safety risk hidden trouble of pharmaceutical wholesale enterprises as the key point, by the provincial drug certification center set up the annual work plan and specific implementation.
Cooperate with the implementation of the policy of "two votes", based on the special medicine circulation in 2016, continued to pharmaceutical wholesale link to carry out the renovation, the key to crack down on unlicensed operation and attached ticket, goods zhang ticket does not agree, not timely issue (for) invoices, statistics, and corporate personnel especially such outstanding problems as salesman chaos, consolidate and expand the rectification of the effect.
▍ hubei: "look back" centralized regulation, tracking check medicine group
In March 2017, hubei bureau issued the 2017 hubei pharmaceutical cosmetics circulation regulation work key point, definitely in 2017 the province medicine cosmetics circulation regulation work will focus on:
To carry out illegal conduct during the "look back", illegal conduct continuous improvement and drug circulation. Organizations to carry out the integration of urban and rural areas and rural areas small pharmacies and clinics, refrigeration freezing pharmaceutical trading enterprises, professional market of Chinese medicinal materials under special supervision and inspection.
To continue will do follow-up investigations on drug GSP pharmaceutical trading enterprises, increase the management risk, administrative punishment, severely increase and use the unit does not keep your words recorded flight inspections. Around the focus of the circulation regulation variety, link to carry out supervision and inspection, timely and effective prevention and control security risks.
▍ hunan: special power, flight check
6th April 5 solstice, hunan province medicine circulation supervision meeting food drug administration.
2017 medicine circulation supervision work to focus on in three aspects: one is to focus our special campaigns in the field of drug circulation, flight check, attending special drugs and drug regulation; Second, must strictly in accordance with the standard finish in vitro diagnostic reagents (drug) business enterprise of GSP certification work; Three is to strictly implement the supervision responsibility, administration according to law, honesty in politics.
▍ guangxi: of the 293 medicine group of companies, an iron fist
On March 23, issued a "drug-handling enterprise flight inspection methods for determination of object (try out)"
On March 21, 2017, the autonomous region bureau of 14 city bureau will organize 293 pharmaceutical wholesale enterprises to carry out the normality of the flight check, the coverage of the wider.
Enterprises on the issue of the flight check, severe punishment, merciless, and released to the public the flight test results, at the same time on medicines and medical equipment centralized purchasing center of guangxi, revoked, canceling the GSP authentication certificate of enterprise qualification of medical institutions and drug distributors.
With an iron hand power during the outstanding problems affecting the safety of drug circulation, further rectified and standardized the order of the circulation of medicines.
▍ sichuan: in violation of the provisions of the "two votes", to hunt down
Issued on April 12, 2017 the implementation of the provincial drug circulation rectification notice "look back".
Strengthening of unlicensed operation drugs; "Affiliated" and "tickets", rent lend licenses; Overspray, super way; Data fraud; In violation of the provisions of the "two votes"; Not according to the requirements of cold chain storage transport drugs; Failure to sell prescription drugs, including special drug compound preparations, and other countries have clear provisions on the administration of drugs; For purchase and marketing Fang Zi qualitative review is not strict, source control is lax supervision and examination of the violation behavior, etc.
Key check varieties
1. The treatment of diabetes, hypertension, cardiovascular disease drugs.
2. The blood products, biological products, vaccines, containing special drug compound preparations, cold-chain drugs, antibacterial, injection risk prone varieties.
▍ shaanxi: check circulation, hang card, check all medicine group
On March 28, 2017, issued the 2017 circulation of medicines and cosmetics in shaanxi supervision work plan of the notice.
For two years by the new GSP certification of enterprise to carry out the track inspection. Creating throughout the province to carry out the flight check, focusing on unlicensed operation and attached ticket, zhang ticket goods inconsistent, data fraud, illegal distribution of such outstanding problems as recycling drugs for inspection.
Combined with GSP track inspection, rectification, flight check work, completion of pharmaceutical wholesale enterprises within their respective jurisdictions covering 100% of the check; Fall to the ground as the "two votes" system, to carry out the supervision and inspection of distribution enterprises, key check whether the purchase sales is strictly implemented two tickets, and ticket bill payment for goods is consistent; Strictly investigate licensed pharmacists hang card phenomenon.
▍ gansu: strictly investigate "black 5 class"
April 1, 2017, issued by the gansu province medicine circulation field rectification work plan of the notice.
Pharmaceutical trading enterprises by May 15, 2017 can take the initiative to find problems, correct illegal problems at the same time, can be given a lighter or mitigated punishment in accordance with the law; Due to failing to report, by the municipal state food and drug regulators to social public enterprise list, as the inspection object.
Strictly, a heavier investigate "black 5 classes", until the revocation of the pharmaceutical trade license.
1, the year due to illegal shall impose administrative punishments against the administrative violations has, continue to engage in illegal activities;
2, last year's inspection found in the process of rectification of law violations not rectification, continue to engage in illegal activities;
3, last year's inspection in the process of rectification of law violations have been found for the rectification, the rectification, and continue to engage in illegal activities;
4, last year's enterprise inspection found no problem, since May 2016, continued to engage in illegal activities;
5, refuse to report, false to hide and introspection is not serious, the rectification is not in place, and continue to engage in illegal activities.
▍ shanxi: forensic means circulation
On March 3, 2017, issued the 2017 provincial food and drug supervision and administration work key point of
Comprehensive, using means of administration, technology, forensic internal external sector linkage, the key difficulties, heavy-handed regulation. Will arrange in throughout the province centralized cross-regional flight check, cover the province's 119 counties (city, area), find out the quality and safety of drug circulation problems, investigate a batch of illegal case.
Each city, a certain proportion randomly pharmaceutical wholesale enterprises, each county randomly a percentage drug retail enterprises and medical organizations, by focusing on cross flight check, violation of laws and regulations and management behavior.
Add: shanxi 23 drug list
|
