Circular No. 28/2011/TT-BYT on amending and supplementing certain articles of Circular No. 13/2010/TT-BYT dated May 12, 2010 guiding the management of rapid food testing kits.

CIRCULAR

Regarding the amendment and supplementation of some articles of Circular No. 13/2010/TT-BYT dated May 12, 2010 guiding the management of rapid food testing kits

guiding the management of rapid food testing kits

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Pursuant to Decree No. 188/2007/NĐ-CP dated December 27, 2007 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

Implementing the simplification of administrative procedures in accordance with the spirit of Resolution No. 62/NQ-CP dated December 17, 2010 of the Government on the simplification of administrative procedures within the scope of the Ministry of Health's management functions;

The Minister of Health issues this Circular amending and supplementing some articles of Circular No. 13/2010/TT-BYT dated May 12, 2010 guiding the management of rapid food testing kits as follows:

Article 1. Amending and supplementing some articles of Circular No. 13/2010/TT-BYT dated May 12, 2010 guiding the management of rapid food testing kits

1. Clause 9 is amended and supplemented as follows:

"Clause 9. Forms of registration for circulation; changes, supplements, and extensions of registration for circulation of rapid food testing kits

1. Registration for circulation of food rapid test kits

The enterprise shall submit the application dossier in accordance with Clause 1, Article 10 of this Circular.

2. Registration for change and addition to the circulation of food rapid test kits

a) For rapid food testing kits that have been granted a registration certificate for circulation, if there is a change or addition to any registered content during the validity period of the registration certificate, such changes must be approved by the registration authority.

b) When changing or adding any of the following contents, the enterprise shall submit the application dossier in accordance with Clause 2, Article 10 of this Circular; the registration authority will consider retaining the original registration number and the registration certificate already issued.

- Changing the shelf life, storage conditions;

- Changing (adding) labeling information;

- Changing the scope of application;

- Changing the detection limit;

- Changing (adding) usage instructions;

- Changing (adding) accuracy (or error) information;

- Changing (adding) packaging specifications.

c) When changing or adding any of the following registered contents, the procedure will be carried out as a new registration for circulation; the enterprise shall submit the application dossier in accordance with Clause 1, Article 10 of this Circular; the registration authority will revoke the previously issued registration certificate and registration number and proceed with the new issuance of the registration certificate and registration number.

- Changing (adding) testing criteria;

- Changing the operating principle;

- Changing the testing characteristics;

- Changing the name of the food rapid test kit;

- Changing the enterprise applying for registration.

3. Extension of registration for circulation of food rapid test kits

Within three months before the expiration date of the registration certificate for circulation, the enterprise has the responsibility to submit the extension application dossier in accordance with Clause 3, Article 2 of this Circular to request an extension of the registration for circulation if it intends to continue circulating in Vietnam.

After the above deadline, if the enterprise has not completed the extension procedures, it must submit the application dossier for registration for circulation in accordance with Clause 1, Article 10 of this Circular."

2. Article 10 is amended and supplemented as follows:

"Article 10. Application dossier for registration for circulation, changes, supplements, and extensions of registration for circulation of rapid food testing kits

1. Documents for Application to Register the Circulation of Rapid Food Testing Kits

The enterprise is responsible for submitting one set of the application dossier for registration for circulation (the dossier must include a list of accompanying documents) to the registration authority, which includes:

a) Application form for registration for circulation of rapid food testing kits (Annex I promulgated together with this Circular);

b) Copy of the business registration certificate (confirmed by the enterprise);

c) Research and testing documents related to the rapid food testing kit; in case these documents are in a foreign language, they must be accompanied by a Vietnamese translation (confirmed by the enterprise);

d) Instructions for using the rapid food testing kit; in case the instructions are in a foreign language, they must be accompanied by a Vietnamese translation (confirmed by the enterprise);

d) Report on the results of the technical evaluation of rapid food testing kits from three technical units selected by the enterprise from the annual list of technical units announced by the Ministry of Health;

e) One sample label of the rapid food testing kit including the direct label on the smallest packaging unit and the indirect label on the outer packaging (stamped by the enterprise);

g) Copy of the manufacturing or export permit issued by the competent authority of the country of origin (for imported rapid food testing kits) and must be legalized by the consulate in English or Vietnamese; in case the permit is in another language, it must be accompanied by a certified translation into Vietnamese;

h) Two sets of rapid food testing samples.

2. Documents for Application to Amend or Supplement Registered Content for Rapid Food Testing Kits

When there are changes or additions to the contents specified in Clause 2, Article 9 of this Circular, the enterprise is responsible for submitting one set of the application dossier (the dossier must include a list of accompanying documents) to the registration authority, which includes:

a) Application form for changing the content of registration for circulation of rapid food testing kits (Annex II promulgated together with this Circular);

b) A certified copy of the registration certificate (including the original certificate and all renewals);

c) Materials related to the proposed amendments or supplements; in case these materials are in a foreign language, they must be accompanied by a Vietnamese translation (confirmed by the enterprise);

d) Two sets of rapid food testing samples.

3. Documents for Application to Extend Registration of Circulation of Rapid Food Testing Kits

The enterprise shall submit one set of application documents for extending the registration of circulation (the documents must include a list of attached materials) to the issuing authority, which includes:

a) Application form for extending the registration certificate for circulation (Annex III promulgated together with this Circular);

b) A certified copy of the registration certificate (including the original certificate and all renewals);

c) One set of rapid food testing samples;

d) A confirmation document on the stability and specificity of at least one technical unit that has used the rapid food testing kit."

3. Article 11 is amended and supplemented as follows:

"Article 11. Competence and procedures for reviewing the issuance of certificates and registration numbers for rapid food testing kits

1. The Ministry of Health delegates to the Food Safety Agency the authority to review applications, issue certificates, and assign registration numbers for rapid food testing kits.

2. The Food Safety Agency shall be responsible for:

a) Receiving registration files;

b) Establishing a specialized expert committee to evaluate food rapid test kits:

- Examining, evaluating, and making conclusions on the scientific basis and practicality, advising the Ministry of Health (Food Safety Agency) on the examination and evaluation of rapid food testing kits;

- Proposing solutions for registering the circulation of food rapid test kits.

c) Based on the conclusions and recommendations of the Council, the Director of the Food Safety Agency will decide:

- Permitting circulation: issuing certificates of registration, or renewing certificates of registration (in cases of changes or additions) for each food rapid test kit;

- Requesting additional information and documents before permitting circulation: notifying the enterprise in writing, specifying the required additional information;

- Not permitting registration for circulation: notifying the enterprise in writing, stating the reasons for not permitting registration for circulation.

d) Time limit for responding to enterprises:

- For applications for registration of rapid food testing kits: within twenty working days from the date of submission of a valid application;

- For applications for changes and supplements to the registration of rapid food testing kits: within ten working days from the date of submission of a valid application;

- For applications for extension of the registration of rapid food testing kits: within five working days from the date of submission of a valid application.

3. The validity period of the certificate for the registration of rapid food testing kits:

a) Certificates of registration for food rapid test kits have a validity period of 5 years from the date of issuance.

b) Certificates of registration can be renewed multiple times, with each renewal having a validity period of 5 years from the date of issuance.

c) For rapid food testing kits that have been issued certificates for registration according to Decision No. 18/2007/QĐ-BYT dated February 27, 2007 of the Minister of Health on the issuance of the "Regulations on the Management of Rapid Food Safety Testing," which have a validity period of five years, after this period, enterprises must follow the prescribed procedures to extend the registration."

Article 2. Effective Date

This Circular takes effect from August 10, 2011./.