Circular 28/2011/tt-Byt: About The Amendments And Supplements To Some Articles Of The Circular No. 13/2009/tt-Byt On May 12, 2010 Instructions To Manage The Fast-Food Testing

Original Language Title: Thông tư 28/2011/TT-BYT: Về việc sửa đổi, bổ sung một số điều của Thông tư số 13/2010/TT-BYT ngày 12 tháng 5 năm 2010 hướng dẫn quản lý bộ xét nghiệm nhanh thực phẩm

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Pursuant to Decree No. 188/2007/ND-CP on December 27, 2007 of the Government functions, tasks, powers and organizational structure of the Ministry of health;

Implementation of the simplification of administrative procedures, in the spirit of resolution No. 62/NQ-CP on December 17, 2010 by the Government on the simplification of administrative procedures in the scope of the management function of the Ministry of health;

The Minister of Health issued a circular amending and supplementing some articles of circular No. 13/2009/TT-BYT on May 12, 2010 instructions to manage the fast-food tests as follows: article 1. Amendments and supplements to some articles of the circular No. 13/2009/TT-BYT on May 12, 2010 instructions to manage the fast-food testing 1. Article 9 be amended and supplemented as follows: "fill out 9. Registration forms in circulation; register the circulation changes, additions and renew registration of circulating the fast food testing 1. Subscribe to circulate the fast food testing business proposal submission prescribed in clause 1, article 10 of this circular.

2. Register the circulation changes, additional sets of fast food examination a) rapid test kits for food have been certificated registered circulation, within the circulation registration certificate is valid, if changed, adding one of the registered content must be approved by the Agency;

b) When changing, adding one of the following content then suggested filing business under the provisions of clause 2, article 10 of this circular; registration authorities will consider retains the registration number and the registration certificate has been issued in circulation:-change the time limit for use, the conditions of preservation;

-Change the (additional) labeling content;

-Change the application scope;

-Change detection limits;

-Change the (additional) instructions for use;

-Change the information about exact speed (or error);

-Change the (additional) packing.

c) When changing, adding one of the following registered content, then the procedure is performed as register circulation; business proposal submission prescribed in clause 1, article 10 of this circular; the registration authorities to revoke the certificate of registration granted and proceed to a new level of review procedures certificate and registration number in circulation:-change the (additional) test criteria;

-Change the active principle;

-Change the nature of tests;

-Change the name of the fast tests;

-Change the suggested business register.

3. Renewal of registration of circulating the fast food tests during the 12 months before the circulation registration certificates expire, the enterprise is responsible for filing the proposal renewed according to the provisions in clause 3, article 2 of this circular for renewals subscribed circulation if continue circulating in Vietnam.

After the time limit on the unfinished business of renewal procedures to apply the registration proposal floated under the provisions of clause 1, article 10 of this circular ".

2. Article 10 is amended and supplemented as follows: "article 10. The suggested profile register registration, circulation circulation changes, additions and renew registration of circulating the fast food testing 1. Records suggest the circulation registration quick tests of food businesses are responsible for submission of 1 proposal registration record (the records must have a category attached document) for the registration agency, records include: a) petition the register floated the fast food examination (annex I attached to this circular);

b) copy of business registration certificate (certified by the enterprise);

c) The study materials, testing related to the fast food tests; case documents in a foreign language must be accompanied by a Vietnamese translation (of business);

d) instructions for use the quick tests of food; the case of the manual in a foreign language must be accompanied by a Vietnamese translation (of business);

DD) assay results report the fast food tests of 3 technical unit by enterprises in the list of the technical unit are the Ministry of health published annually;

the label of the form e) 01 fast food tests include the label directly on the smallest packaging unit and indirectly on the package label (stamped by the enterprise);

g) a copy of the license issued in the country of production, export by the competent State agencies of the country (for quick test kit registration food import origin) and consular legalization must be in English or Vietnamese; the case of a licence issued in another country must be accompanied by a Vietnamese translation notarized;

h) 2 sets of sample fast food.

2. The records suggest change, additional registered content circulating for the fast food tests When there's change, addition of content specified in paragraph 2, article 9 of this circular, enterprises are responsible for filing 1 record (the records must have a category attached document) for registration authorities profile, including: a) petition to change subscription content circulating the fast food examination (annex II attached to this circular);

b) a copy of the certificate of registration (including the certificate was issued and the first renewal);

c) documents pertaining to the suggested content changes and supplements; case documents in a foreign language must be accompanied by a Vietnamese translation (of business);

d) 2 sets of sample fast food.

3. Profile registration renewal proposals floated the quick tests of food businesses are responsible for filing 1 record registration renewal proposals floated (profile must have the document list attached) for registration agency, records include: a) petition to renew the certificate of registration (annex III attached to this circular);

b) a copy of the certificate of registration (including the certificate was issued and the first renewal);

c) 1 set of sample fast food;

d) have written confirmation of stability and of at least one engineering unit had used the tests as fast food ".

3. Article 11 is amended and supplemented as follows: "article 11. The jurisdiction and procedures of the certification review and the registration number issued for the fast-food testing 1. The Ministry of health authorize the Bureau of food safety assessment implementation profile, certification, registration number issued for the tests as fast food.

2. The Bureau of food safety and hygiene is responsible for: a) receiving registration documents;

b) establishing expert appraisal Board reviews the fast food: tests-review reviews and draw conclusions on the basis of science, practical, advice to the Ministry of health (the Bureau of food safety and hygiene) in the review, the review of fast food tests;

-Proposed resolution form the register floated for the fast food tests.

c) on the basis of the conclusions and recommendations of the Board, Director of food safety and hygiene will decide to:-allow circulation: registration certificates in circulation, or change the certificate (for case changes, supplements) for each set of tests fast food;

-Request additional information and documents before allowing the circulation: notice for business in writing, stating the need for additional requirements;

-Do not allow registration circulation: notice for business writing, which stated the reason for not allowing subscription circulation.

d) time limit for reply results for business:-for registered records released the fast food tests: no more than 20 working days from the date of filing;

-For registration documents circulation changes, additional sets of tests are fast food: not more than 10 working days from the date of filing;

-Registration for the extension of the fast-food test: not more than 10 working days from the date of filing.

3. The time limit for registration certificates in circulation the fast food tests: a) the certificate of registration issued sets of fast food test has a time limit of 5 years from the date of signing.

b) registration certificates in circulation was renewed several times, the renewal takes effect for 5 years from the date of signing.

c) for the fast-food test has been issued a certificate of registration issued pursuant to decision No. 18/2007/QD-BYT on 27 February 2007 the Minister of health on issuing "regulations quick tests for food safety", the time limit of 5 years , after the time limit on, business must do the registration renewal procedures released under the regulations ".

Article 2. Effective enforcement of this circular effect from January 10, 2011.