Chương II Thông tư 23/2018/TT-BYT: Hình thức, trình tự thu hồi

Chapter II

TYPES AND PROCEDURES FOR RECALL OF DISQUALIFIED PRODUCTS

Article 3. Types of recall

1. Voluntary recall is a recall of products voluntarily conducted by organizations or individuals that register the declarations of products or carry out the self-declaration of products (hereinafter referred to as “product owners”) after the discovery or receipt of feedback about safety issues concerning their products other than the case prescribed in Clause 2 of this Article.

2. Mandatory recall is a recall of disqualified products carried out by product owners following the issuance of a mandatory recall decision by:

a) The competent authority that receives their self-declaration documents or issues the certificate of registered product declaration as regulated in the Government's Decree No. 15/2018/ND-CP dated February 02, 2018 (hereinafter referred to as “food safety authority”); or

b) The authority competent to impose penalties for administrative violations against regulations on food safety as regulated by laws.

Article 4. Procedures for voluntary recall

1. Within 24 hours after the discovery or receipt of feedback about safety issues of products and it is concluded that the products have to be recalled, the product owner shall:

a) Notify the recall by telephone, email or in other appropriate forms, and then give written notification to all members of the production and distribution system (including factories, distributors, agencies and stores) in order to request them to suspend the production and distribution of products as well as carry out the recall of products;

b) Give written notification to provincial mass media agencies and other relevant authorities and organizations as regulated by the soft law on protection of consumer rights; If the recall involves two provinces or more, central mass media agencies must be notified in writing in order to publish such recall to consumers;

c) Give written notification of the recall to food safety authorities;

d) When giving written notification of the recall, the product owner must specify name and address of the product owner and of the manufacturer, product’s name, packaging specifications, batch number, date of manufacture, expiration date, quantity, reasons for recall, list of locations receiving recalled products, and recall duration.

2. Within 03 days from the completion of the recall, the product owner must submit a report on the recall of products, which also includes measures for disposal of recalled products, to food safety authorities according to the Form No. 01 enclosed herewith.

Article 5. Procedures for mandatory recall

1. Within 24 hours after it is concluded that the products are subject to the mandatory recall, the authority that has the power to issue a recall decision as regulated in Clause 2 Article 3 hereof shall issue a recall decision made according to the form provided in the Appendix 02 enclosed herewith.

2. Upon the receipt of the recall decision, the product owner must carry out the procedures specified in Clause 1 Article 4 hereof.

3. Within 03 days from the completion of the recall, the product owner must submit a report on the recall of products, which also includes measures for disposal of recalled products, to the authority issuing the recall decision according to the Form No. 01 enclosed herewith.

4. After issuing a recall decision, authorities competent to impose penalties for administrative violations against regulations on food safety must supervise the recall of products and notify food safety authorities and relevant authorities for cooperation.

Article 6. Procedures for recall in serious cases or an emergency

1. In case a product owner fails to carry out the recall or conducts the recall inconsistently with the mandatory recall decision issued by a competent authority or in another case of emergency as regulated in Point d Clause 5 Article 55 of the Law on food safety, the competent authority shall issue a decision to enforce and organize the recall. A decision on enforced recall of products must specify the name of the authority or organization responsible for that enforcement, name of the authority or organization supervising or witnessing the enforced recall of products, time limit for completion of the enforced recall and measures for disposal of recalled products.

2. Upon the completion of the recall and disposal of recalled products, the authority carrying out the recall and disposal of recalled products shall give a written notification requesting the product owner to pay expenses arising during the recall.

3. The product owner shall pay the costs of recall and disposal of recalled products (if any) within 15 days from the receipt of a written notification from the authority in charge of organizing the recall.