Provisions for Drug Recall (SFDA Decree No. 29)

Chapter 4 Ordered Recall

Article 25 When the drug manufacturer doesn't take the initiative to recall the drug that is found to have safety hazards described in Article 4 of these Provisions during investigation and assessment conducted by the drug regulatory department, the drug regulatory department shall order the drug manufacturer to recall the drug.

The drug regulatory department may require the drug manufacturer, distributor and user to stop selling and using the drug immediately if necessary.

Article 26 After making the decision to order the recall, the drug regulatory department shall send the notice of ordered recall to the drug manufacturer. The notice includes the following items:

(Ⅰ) Specific information about the recalled drug, including basic information such as name and batch number;

(Ⅱ) Causes of the recall;

(Ⅲ) Results of the investigation and assessment;

(Ⅳ) Requirements for the recall, including the scope and time limit.

Article 27 After receiving the notice of ordered recall, the drug manufacturer shall notify the drug distributor and user according to the provisions in Article 16 and Article 17 of these Provisions, formulate and submit the recall plan and organize its implementation.

Article 28 The drug manufacturer shall report the relevant information of the recall to the drug regulatory department according to the provisions in Article 20, Article 21, Article 22 and Article 23 of these Provisions, and engage in subsequent handling of the recalled drug.

The drug regulatory department shall review the drug recall summary report submitted by the drug manufacturer according to the provisions in Article 24 of these Provisions and evaluate the recall effect. If the review and evaluation find the recall inexhaustive and that more effective measures are needed, the drug regulatory department shall require the drug manufacturer to make another round of recall or expand the scope of recall.

Chapter 5 Legal Responsibilities

Article 29 According to law, the drug regulatory department shall impose administrative punishment/sanctions on drug manufacturers that are confirmed to have caused safety hazards in drugs on the market by violating relevant laws, rules and regulations. The manufacturers who have taken active recall measures to eliminate or mitigate harmful consequences shall receive lenient or mitigated punishment; the manufacturers who have committed minor violations and made prompt corrections but have not caused any serious consequences shall be exempted from punishment.

The drug manufacturer who has recalled the drug shall not be exempted from other legal liabilities that it shall bear according to law.

Article 30 Drug manufacturers who have found safety hazards with drugs but failed to recall the drug voluntarily in violation of these Provisions shall be ordered to recall the drug and fined 3 times the value of the drugs to be recalled; for those who have caused serious consequences, their approval documents shall be withdrawn by the original certificate-issuing department, or even worse, their Drug Manufacturing Certificate shall be revoked.

Article 31 Drug manufacturers who refuse to recall drugs in violation of the provisions in Article 25 of these Provisions shall be fined an amount of 3 times as much as the value of the recalled drug (the drug to be recalled); for those who have caused serious consequences, their approval documents shall be withdrawn by the original certificate-issuing department, or even worse, their Drug Manufacturing Certificate shall be revoked.

Article 32 Drug manufacturers who fail to notify the drug distributor and user to stop selling and using the drug to be recalled within the specified time in violation of the provisions in Article 16 of these Provisions shall be warned, ordered to rectify the situation within a time limit and fined (an amount) less than 30,000 Yuan.

Article 33 Drug manufacturers who fail to take corrective measures or recall the drug as required by the drug regulatory department in violation of the provisions in Article 19, paragraph 2 of Article 24 and paragraph 2 of Article 28 shall be warned, ordered to rectify the situation within a time limit and fined an amount less than 30,000 Yuan.

Article 34 Drug manufacturers who violate the provisions in Article 22 of these Provisions shall be warned, ordered to rectify the situation within a specified period and fined an amount less than 30 thousand Yuan.

Article 35 Drug manufacturers shall be warned, ordered to rectify the situation within a time limit in any of the following circumstances:

(Ⅰ) Fail to establish the drug recall system, drug quality assurance system and adverse drug reaction monitoring system according to these Provisions;

(Ⅱ) Refuse to assist the drug regulatory department in carrying out investigation;

(Ⅲ) Fail to submit the investigation and assessment report and plan for recall of the drug, updates on the recall and summary report;

(Ⅳ) Fail to report the changes of the recall plan to the drug regulatory department for record.

If they fail to rectify within the time limit, they shall be fined not more than 20,000 Yuan.

Article 36 Drug distributors and users who violate the provisions in Article 6 of these Provisions shall be ordered to stop selling and using the drug and fined an amount more than 1,000 Yuan and less than 50 ,000Yuan; for those who have caused serious consequences, the original certificate-issuing department shall revoke their Drug Supply Certificate or other certificates.

Article 37 Drug distributors and users who refuse to cooperate with drug manufacturers or drug regulatory departments in carrying out investigation on safety hazards of drugs and refuse to assist drug manufacturers in recalling drugs shall be warned, ordered to rectify within a time limit and fined (an amount) less than 20,000 Yuan.

Article 38 Drug regulatory departments and their staff who fail to perform their duties or abuse their authority shall be held accountable according to relevant laws and regulations.

Chapter 6 Supplementary Provisions

Article 39 The right to interpret these Provisions resides in the State Food and Drug Administration.

Article 40 These Provisions shall go into effect as of the date of promulgation.