Sold inferior drugs were fined 1.11 million! All pharmacies should be vigilant.

Typical case exposure: a pharmaceutical company was fined 1.11 million days ago, Fujian Provincial Drug Administration announced a typical administrative penalty case, a pharmaceutical company for the sale of melonshot drugs were fined 1.11 million.
called the case typical for two key reasons.
, the case was investigated after the State Drug Administration launched a major crackdown on Chinese medicine tablets.
the requirements, all parts of the country in July this year to June next year, to carry out a year-long centralized inspection of Chinese medicine tablets.
, the drug company became a model in the treatment.
Second, from December 1 last year, known as "the most stringent in history" of the Drug Administration Law was officially implemented, and in this section of the bone eye, the pharmaceutical company stepped on the "sale of inferior drugs" of the thunder, opened a "big single" (total fine of 1110903.49 yuan).
illegal income of 4460.86 yuan, a fine of 1.1 million nonsense not much to say, next, the author first take you to see the reasons for the drug company was fined (or the main illegal facts).
According to the Public Table of Administrative Penalty Information of the Fujian Provincial Drug Administration, the sale of inferior drugs and melonsby the parties before December 1, 2019 violated the provisions of Article 49 (1) of the Drug Administration Law of the People's Republic of China (2015 Amendment);
information disclosure form also shows that the parties know or should know that the batch of melonsis unqualified drugs, still have not taken measures to stop the sale of drugs in accordance with the law, and continue to sell inferior drugs, and the drug business quality management norms, Article 87, Article The provisions of Article 117 are inconsistent and violate the provisions of Article 16 (1) of the Drug Administration Law of the People's Republic of China (amendment 2015) and Article 53 (1) of the Drug Administration Law of the People's Republic of China (revised in 2019).
At the same time, the parties concerned failed to carry out acceptance in accordance with Article 78 of the Code of Quality Management of Pharmaceutical Operations, resulting in the flow of unqualified drugs into the market, in violation of Article 17 of the Drug Administration Law of the People's Republic of China (2015 Amendment) and Article 56 of the Drug Administration Law of the People's Republic of China (revised in 2019).
relevant provisions, the Government decided to punish the following: 1, confiscation ofand Chinese medicine tablets 43.254 kg; 2, confiscation of the sale of inferior drugs melons Chinese medicine drink tablets illegal income of 4460.86 yuan; 3, illegal acts occurred before December 1, 2019, illegal sale of inferior drugs melons 4, illegal acts occurred after December 1, 2019, the illegal sale of inferior drugs melon The value of Chinese medicine drink tablets 11 times the value of the fine (the value of illegal drugs less than 100,000 yuan, according to 100,000 yuan) amount of 1100,000 yuan.
total fine of 1110903.49 yuan.
Selling counterfeit drugs minimum penalty of 1.5 million, retail shoddy drug minimum penalty of 100,000 through this case, the author again to give you a wake-up call, the current illegal costs are very high, especially the sale of counterfeit drugs, no matter how much, according to the new version of the Drug Administration Law, the minimum penalty for selling counterfeit drugs 1.5 million, retail shoddy drugs minimum penalty of 100,000.
, according to Article 98 of the new Version of the Drug Administration Law, the production (including preparation, the same between), the sale, use of counterfeit drugs and inferior drugs are prohibited.
If one of the following circumstances occurs, it shall be a counterfeit drug: the contents of the drug do not conform to the contents stipulated in the national drug standards;
If there are any of the following circumstances, it is inferior: the content of the pharmaceutical ingredients does not meet the national drug standards; the contaminated drugs; the drugs that do not indicate or change the validity period; the drugs that do not indicate or change the batch number of the product; the drugs that exceed the validity period; the drugs that add preservatives and accessories without authorization; and other drugs that do not meet the drug standards.
the provisions, if the enterprise has the above behavior, need to bear the following legal responsibilities.
First, those who produce or sell counterfeit drugs shall confiscate the drugs and illegal income illegally produced or sold, order the suspension of production and rectification, revoke the certificate of drug approval, and be fined 15 times or less than 30 times the value of the drugs illegally produced or sold. If the value of the goods is less than 100,000 yuan, it shall be calculated at 100,000 yuan; if the circumstances are serious, the drug production license, the drug business license or the medical institution's preparation license shall be revoked and the corresponding application shall not be accepted within ten years; and the holder of the drug listing license shall be an overseas enterprise and the import of the drug shall be prohibited for ten years.
Second, those who produce or sell inferior drugs shall confiscate the drugs and illegal income illegally produced or sold, and shall be fined between ten times and not more than twenty times the value of the drugs illegally produced or sold; If the value of the illegal retail drug is less than 10,000 yuan, it shall be calculated at 10,000 yuan; if the circumstances are serious, the company shall be ordered to stop production and rectify the drug approval documents, the drug production license, the drug business license or the medical institution's preparation license.
chinese medicine tablets produced and sold do not meet the drug standards and do not affect safety and effectiveness, they shall be ordered to make corrections within a specified period of time and given a warning;
, if the circumstances are serious, the corresponding person in charge will also be punished.
For legal representatives, principal persons in charge, persons in charge directly responsible and other responsible persons, the confiscation of the income obtained from the unit during the period of the illegal act, and the fine of more than 30 percent of the income received by the department, the life-long prohibition of engaging in pharmaceutical production and business activities, and may be detained by the public security organs for five to 15 days.
shall confiscate raw materials, accessories, packaging materials and production equipment used by producers specifically for the production of counterfeit and inferior drugs.
It should be noted that those who know or should know that they belong to counterfeit drugs, inferior drugs or drugs prescribed in Article 124, paragraphs 1 to 5 of this Law, and provide them with convenient conditions such as storage and transportation, shall confiscate all storage and transportation income and shall be fined between one and five times the illegal income;
The drugs stipulated in article 124, paragraphs 1 ( 1 to 5) are as follows: (1) the production and import of drugs without obtaining the certificate of approval for the drug; (2) the production and import of drugs using the certificate of approval of the drug obtained by deception; (3) The production of medicines using raw materials approved without examination and approval; (4) the sale of drugs without examination; (5) the production and sale of drugs prohibited by the drug supervision and administration department under the State Council; the whole country is investigating Chinese medicine tablets, including retail pharmacies, in addition, in accordance with the State Drug Administration's Special Rectification Work Programme for Chinese Medicine Tablets (Pharmaceutical Supervision and Administration (2020) No. 12), and the Chinese medicine tablets and preparations production enterprises and Chinese medicine tablets shall be inspected.
, the operating and using units of Chinese medicine tablets shall focus on checking the illegal production and operation of Chinese medicine tablets and the purchase of Chinese medicine tablets from illegal channels.
specified as follows: 1, illegal production and operation of Chinese medicine tablets behavior.
Check whether there is a sale of illegally processed and illegally sub-packed Chinese medicine tablets, check whether there is a situation in which a "library" is set up to store Chinese medicine tablets or hang on to the operation of Chinese medicine tablets, check whether it provides a place for others to illegally operate Chinese medicine tablets, qualification documents, bills and other conditions.
2, from illegal channels to buy Chinese medicine tablets behavior.
Check whether there is a purchase of Chinese medicine tablets from a non-qualified unit, check whether to obtain the corresponding qualification certificate, legal bills (including sales list, accompanying peer list, etc.) and the corresponding batch product inspection report, check whether the purchase, acceptance, storage, maintenance, inventory review and other aspects of Chinese medicine drink tablets as required to effectively manage, and do a good job of recording.
combing found that in the recent period of time, there have been many cases of the sale of fake and inferior Chinese medicine tablets were punished, which also include pharmacies, small to remote mountain monomer pharmacies, large to the domestic well-known listed chain, not immune.
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