Affected all pharmaceutical companies, ushered in a major overhaul after 14 years!

1.
Revised the definition of drug recall

 Interpretation:

The definition of drug recall is revised in accordance with the provisions of Article 82 of the Drug Administration Law of the 2019 edition, as well as the actual drug recall situation and handling methods.
The "drugs that have been marketed and have safety hazards" are revised to "the drugs that have been marketed and have defects.
drugs "and adds," and take appropriate measures to control activities to eliminate defects "
.

Article 82 of the "Drug Administration Law": If the drug has quality problems or other safety hazards, the drug marketing authorization holder shall immediately stop the sale, inform the relevant drug dealers and medical institutions to stop the sale and use, and recall the drugs that have been sold , Disclose the recall information in a timely manner, immediately stop production when necessary, and report the drug recall and handling of the drug to the drug supervision and management department of the people's government of the province, autonomous region, and municipality directly under the Central Government and the health authority
.
Pharmaceutical production enterprises, pharmaceutical trading enterprises and medical institutions shall cooperate
.

If the holder of the drug marketing license should recall the drug in accordance with the law, but the drug is not recalled, the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government shall order the recall
.

2.
Adjusted the scope of drug recall

 Interpretation:

Due to improper storage and transportation, labeling and other reasons, there may be risks that affect drug safety or use.
According to the principle of preventing and controlling drug quality and safety risks, the scope of drugs that actually need to be recalled is expanded to Drugs that have quality problems or other safety hazards due to reasons such as transportation and labeling
.
"

3.
Clarified the relevant requirements for the publication of drug recall information

Interpretation:

In accordance with the relevant provisions of the "Drug Administration Law", it is clarified that the drug marketing authorization holder is responsible for the disclosure of drug recall information; and the relevant requirements of the drug regulatory authority for the disclosure of recall information are clarified
.

Implement the territorial supervision responsibility of the provincial drug regulatory department where the drug marketing license holder is located, and consider the severity of the health hazard caused by the defective drug to the human body.
For the implementation of the first and second drug recalls, Article 17 of this "Measures" The second paragraph and the second paragraph of Article 25 require the website of the provincial drug regulatory authority where the drug marketing authorization holder is located to publish recall information
.

 
4.
Deleted the legal liability clauses related to drug recalls

  Interpretation:

No additional penalties
.
If the holder of the drug marketing license orders the recall but refuses to do the recall, or the drug manufacturer, drug distributor, or user unit fails to cooperate with the recall, it shall be punished in accordance with the provisions of Article 135 of the Drug Administration Law
.

Article 135 If the holder of a drug marketing authorization refuses to recall after the drug regulatory department of the people’s government of a province, autonomous region, or municipality has ordered it to be recalled, a fine of five to ten times the value of the drug to be recalled shall be imposed.
; If the value of the goods is less than 100,000 yuan, it will be calculated as 100,000 yuan; if the circumstances are serious, the drug approval documents, drug production licenses, and drug business licenses shall be revoked, and the legal representative, the main responsible person, and the directly responsible person in charge shall be revoked And other responsible persons shall be fined not less than 20,000 yuan but not more than 200,000 yuan
.
If a drug manufacturer, drug distributor, or medical institution refuses to cooperate with the recall, a fine of not less than 100,000 yuan but not more than 500,000 yuan shall be imposed
.

   5.
Clarified requirements for drug recall records

Interpretation:

Added the way that drug marketing authorization holders can choose to destroy under the supervision of the drug regulatory authority or the notary authority
.
Due to the expansion of the scope of the recall, the original "Measures" did not have specific and clear disposal requirements for recalled drugs initiated for other reasons that do not need to be destroyed, and there are actual operational difficulties
.

 references

[1]