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THE
MINISTER OF HEALTH
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SOCIALIST
REPUBLIC OF VIET NAM
Independence - Freedom – Happiness
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No.
28/2011/TT-BYT
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Hanoi,
June 24, 2011
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CIRCULAR
AMENDING
AND SUPPLEMENTING A NUMBER OF ARTICLES OF CIRCULAR NO. 13/2010/TT-BYT OF MAY
12, 2010, GUIDING THE MANAGEMENT OF QUICK FOOD TEST KITS
Pursuant to the Government's
Decree No. 188/2007/ND-CP of December 27, 2007, defining the functions, tasks,
powers and organizational structure of the Ministry of Health;
In performing the
simplification of administrative procedures in the spirit of the Government's
Resolution No. 62/NQ-CP of December 17, 2010, on simplification of
administrative procedures under the Ministry of Health's management;
The Minister of Health issues
the circular amending and supplementing a number of articles of Circular No.
12/2010/TTBYT of May 12, 2010, guiding the management of quick food test kits,
as follows:
Article 1. To amend and
supplement a number of articles of Circular No. 12/2010/TTBYT of May 12, 2010,
guiding the management of quick food test kits
1. To amend and supplement
Article 9 as follows:
"Article 9. Forms of
circulation registration; modified and supplemented circulation registration,
and extension of circulation registration of quick food test kits
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Enterprises shall submit
dossiers of request under Clause 1, Article 10 of this Circular.
2. Modified and supplemented
circulation registration
a/ For quick food test kits
which already have circulation registration certificates, during the validity
term of their certificates, approval of registration certificate-issuing
agencies is required for change or supplementation of any of their registered
contents;
b/ When changing or adding any
of the following contents, an enterprise shall submit a dossier of request
under Clause 2, Article 10 of this Circular; the registration
certificate-issuing agency shall consider retain the circulation registration
number and the granted circulation registration certificate:
- Change of the life time or
preservation conditions;
- Change (supplementation) of
label contents;
- Change of scope of
application;
- Change of limit of finding;
- Change (supplementation) of
use instructions;
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- Change (supplementation) of
packaging specifications.
c/ When changing or
supplementing any of the following registered contents, procedures shall be carried
out as in the case of circulation registration; enterprises shall submit
dossiers of request under Clause 1, Article 10 of this Circular; registration
certificate-issuing agencies shall revoke the granted certificates and
registration numbers and carry out procedures for considering the issuance of
new ones:
- Change (supplementation) of
testing indicators;
- Change of operational
principles;
- Change of testing
characteristics;
- Change of name of the quick
test kit;
- Change of the enterprise requesting
the registration.
3. Extension of circulation
registration of quick food test kits
Within 3 months before the
expiration of its circulation registration certificate, an enterprise shall
submit a dossier of request for circulation registration extension according to
Clause 3, Article 10 of this Circular if the quick food test kits continue
being circulated in Vietnam.
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2. To amend and supplement
Article 10 as follows:
"Article 10. Dossiers of
request for circulation registration and modified and supplemented circulation
registration, or extension of circulation registration of quick food test kits
1. A dossier of request for
circulation registration of a quick food test kit
An enterprise shall submit to
the registration certificate-issuing agency 1 set of dossier of request for
circulation registration (enclosed with a list of attached documents) which
comprises:
a/ An application for
circulation registration of a quick food test kit (made according to the form
provided in Appendix I to this Circular);
b/ A copy of the business
registration certificate (with the enterprise's certification);
c/ Research and testing
documents related to the quick food test kit. Foreign-language documents must
be enclosed with their Vietnamese translations (with the enterprise's
certification);
d/ Instructions for use of the
quick food test kit. Foreign-language use instructions must be enclosed with
their Vietnamese translations (with the enterprise's certification);
e/ Reports on results of testing
of the quick food test kit of three technical units selected by the enterprise
itself from the list of technical units annually announced by the Ministry of
Health;
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g/ A copy of the circulation
permit in the country of manufacture or exportation, granted by a competent
state agency of this country (for case of registration of an imported quick
food test kit) and legalized by a consulate, in English or Vietnamese. For a
circulation permit in another foreign language, it must be enclosed with its
notarized Vietnamese translation;
h/ Two samples of the quick food
test kit.
2. Dossiers of request for
change or supplementation of registered contents of quick food test kits
When there is a change of or
supplement to a content specified in Clause 2, Article 9 of this Circular, the
enterprise shall submit to the certificate-issuing agency one dossier set
(enclosed with a list of attached documents), which comprises:
a/ A written request for change
of a content of the circulation registration of the quick food test kit (made
according to the form provided in Appendix II to this Circular);
b/ A copy of the circulation
registration certificate (including the first-time certificate and extended
certificates);
c/ Documents related to the
change or supplementation of the registered content. Foreign-language documents
must be enclosed with their Vietnamese translations (with the enteiprise's
certification);
d/ Two samples of the quick food
test kit.
3. Dossiers of request for
extension of circulation registration of quick food test kits
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a/ A written request for
extension of the circulation registration certificate (made according to the
form provided in Appendix III to this Circular);
b/ A copy of the circulation registration
certificate (including the first-time certificate and extended certificates);
c/ One sample of the quick food
test kit;
d/ Documents certifying the
stability and special effect of at least one technical unit having used the
quick food test kit."
3. To amend and supplement
Article 11 as follows:
"Article 11. Competence and
procedures for considering the issuance of certificates and circulation
registration numbers for quick food test kits
1. The Ministry of Health
authorizes the Food Safety Administration to examine dossiers and issue
circulation registration certificates and numbers to quick food test kits.
2. The Food Safety
Administration shall:
a/ Receive dossiers of request
for registration;
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- To examine, appraise and make
conclusions on scientific grounds and practicality of the quick food test kit
and advise the Ministry of Health (the Food Safety Administration) on
considering and evaluating the kit;
- To propose the way of making
circulation registration for the kit.
c/ On the basis of conclusions
and proposals of the council, the Director of the Food Safety Administration
shall decide to:
- Permit the circulation of a
quick food test kit by issuing a circulation registration certificate to the
kit or renewing its certificate (for cases of change or supplementation);
- Request addition of
information and documents before permitting circulation by notifying such in
writing to the enterprise, clearly stating the request;
- Disallow the circulation
registration by notifying such in writing to the enterprise, clearly stating
the reason.
d/ Time limit for replying
enterprises:
- Twenty working days after the
date of submission of a valid dossier, for dossiers of circulation registration
of quick food test kits;
- Ten working days after the
date of submission of a valid dossier, for dossiers of modified and
supplemented circulation registration of quick food test kits;
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3. Validity term of certificates
of circulation registration of quick food test kits:
a/ A certificate of circulation
registration of a quick food test kit is valid for 5 years after the date of
its signing;
b/ A certificate of circulation
registration of a quick food test kit may be extended many times with each
extension valid for 5 years after the date of its signing;
c/ For quick food test kits
already have certificates of circulation registration issued under the Minister
of Health's Decision No. 18/ 2007/QD-BYT of February 27, 2007, promulgating the
Regulation on management of quick testing of food hygiene and safety,
enterprises shall carry out procedures for extending these certificates upon
the expiration of their 5-year validity term.
Article 2. Effect
This Circular takes effect on
August 10, 2011.-
FOR
THE MINISTER OF HEALTH
DEPUTY MINISTER
Trinh Quan Huan
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