A pharmacy fined 2 million yuan, the strictest supervision is coming

Under the New Drug Administration Law, a pharmacy sold inferior drugs and was fined more than 2 million yuan.

Drugstore fined more than 2 million yuan for selling inferior drugs

A few days ago, China Judgment Documents.

The verdict information shows that on February 27, 2020, supervisors from Dapu County, Meizhou City, Guangdong Province conducted a routine law enforcement inspection of a pharmacy and found 30 boxes of labels marked "06 Laozhuang Xinkaihe" with a label price of 2850 yuan per box.

In addition, the supervisors also found 5 boxes of Chinese Changbai Mountain Xinkaihe ginseng labelled "99 years old village Xinkaihe" with a label price of 6690 yuan per box.

According to the relevant provisions of Article 98, Paragraph 3 of the "Pharmaceutical Administration Law of the People's Republic of China", medicines that have not indicated or changed the product batch number and expiration date are inferior drugs.

The local regulatory authority believes that Guangdong Province launched a first-level public health response on January 23, 2020.

Based on the above violations of laws and regulations, local regulatory authorities imposed the following penalties on pharmacies on June 3, 2020:

1.

2.

In addition, the local supervisory authority also informed the pharmacy of the time limit, location, and method for paying fines, as well as the additional fines imposed after the deadline, as well as the method and time limit for applying for administrative reconsideration or filing administrative litigation relief rights.

However, the pharmacy did not hand in the fine.

The court held that the punishment decision procedure of the local regulatory authority was legal, the evidence was sufficient, and the application of the law was correct; the pharmacy’s claim to revoke the punishment decision was not supported by insufficient grounds.

According to the first paragraph of Article 117 of the "Pharmaceutical Administration Law of the People's Republic of China", the sale of inferior drugs shall be confiscated of the illegally sold drugs and illegal income, and the value of the illegally sold drugs shall be more than ten times and twenty times the value of the drugs sold.

In the end, the court ruled that the appeal request of the pharmacy was rejected and the original penalty decision of the local regulatory authority was maintained.

Starting with a fine of 1.

The author sorted out some of the regulations (counterfeit drugs, inferior drugs) of the new and old drug management laws and sorted them out as follows:

1.

Second, those who produce or sell inferior drugs shall confiscated the illegally produced and sold drugs and illegal income, and impose a fine of ten to twenty times the value of the illegally produced and sold drugs; the value of illegally produced and wholesale drugs If the amount is less than 100,000 yuan, it is calculated as 100,000 yuan, and if the value of illegally retailed drugs is less than 10,000 yuan, it is calculated as 10,000 yuan.
(Old version: For those who produce or sell inferior drugs, the illegally produced or sold drugs and illegal income shall be confiscated, and a fine of more than one time and less than three times the value of the illegally produced or sold drugs shall be imposed.
)

It can be seen that under the penal provisions of the New Drug Administration Law, pharmacies illegally sell counterfeit drugs, starting with a fine of 1.
5 million, and illegally selling inferior drugs starting with 100,000.
Compared with the old regulations, the new Drug Administration Law has raised the minimum fines a lot.
Even if the illegal sales of counterfeit and inferior drugs have little benefit, they will still be fined.

Why are the penalties in the New Drug Administration Law so harsh? Xu Yanzeng, director of the Hebei Provincial Drug Administration, once stated in an interview with People's Daily that at the operational level, drug supervision must implement the "four most stringent" requirements of superiors, and resolve issues such as severe investigations and punishments.
Be reflected in the law.

New regulations are implemented, pharmacies face the most stringent inspections

For pharmacies, the new Drug Administration Law is punished severely, while the "Administrative Measures for Drug Inspection (Trial)" (hereinafter referred to as the "Measures") promulgated on May 28 is strict in inspection.

The "Measures" mentioned that according to the nature and purpose of the inspection, drug inspections are divided into licensing inspections, routine inspections, due-cause inspections, and other inspections.
The scope of the above inspections all cover retail pharmacies.

In terms of pharmacy license inspection, for the first application for the "Drug Distribution License" and the application for the "Drug Distribution License" for changes in licensing items and on-site inspections are required, on-site inspections shall be carried out in accordance with the GSP and its on-site inspection guidelines, licensing inspection rules and other relevant standards.
; Those who apply for the re-issuance of the "Pharmaceutical Business License" shall be reviewed in accordance with the risk management principles based on the company's compliance with drug management laws and regulations, GSP and quality system operations, and GSP compliance inspections can be carried out when necessary.

Regarding the licensing inspection of retail chain enterprises and pharmaceutical retail chain enterprises, if the number of pharmaceutical retail chain stores is less than or equal to 30, random inspection shall be conducted at a rate of 20%, but not less than 3; if more than 30, a random inspection shall be conducted at 10%.
, But not less than 6 companies.
If the random-checked drug retail chain stores are set up across provinces (autonomous regions, municipalities), the provincial drug regulatory authority that organizes licensing inspections may conduct joint inspections when necessary.

Regarding routine inspections of pharmacies, the drug regulatory authority formulates a drug inspection plan based on risk principles, determines the list of inspected units, inspection content, inspection focus, inspection methods, inspection requirements, etc.
, implements risk management, and the annual inspection plan should determine a certain ratio Of the inspected units carry out compliance inspections of quality management norms.

It should be noted that when the relevant departments conduct routine inspections, they can adopt inspection methods that are not notified in advance.
They can inspect a certain link or the content specified in the inspection plan, and conduct a comprehensive inspection when necessary.
In addition, the frequency of routine inspections shall be implemented in accordance with the relevant regulations and requirements of drug production and operation.

The following is the general inspection content:

1.
Comply with the legality of drug management laws and regulations.

2.
Implement the normativeness of relevant drug quality management practices and technical standards.

3.
The authenticity and completeness of the information and data on the production, operation and use of drugs.

4.
Quality management and risk prevention and control capabilities of drug marketing license holders.

5.
Other content that the drug regulatory department considers to be inspected.

In addition, for the sale of narcotic drugs, psychotropic drugs, pharmaceutical precursor chemicals, radioactive drugs, and toxic drugs for medical use, the supervisory authority should also inspect the implementation of relevant regulations such as ensuring the safety of drug management by enterprises and preventing the flow into illegal channels.
.

Regarding pharmacies' due-cause inspections, in one of the following situations, the regulatory authorities may conduct due-cause inspections after the risk assessment:

1.
Complaints, reports or clues from other sources indicate that there may be quality and safety risks;

2.
The inspection finds that there is a quality and safety risk;

3.
Monitoring of adverse drug reactions suggests that there may be quality and safety risks;

4.
There are doubts about the authenticity of the declared materials;

5.
Suspected of serious violation of relevant quality management regulations;

6.
The enterprise has a record of serious non-compliance;

7.
The enterprise frequently changes the registration items of management personnel;

8.
Potential safety hazards are discovered during the batch issuance of biological products;

9.
The inspection finds that there are hidden dangers in the safety management of special drugs;

10.
Special drugs are suspected of flowing into illegal channels;

11.
Other situations that require inspections for reasons.