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THE
MINISTRY OF HEALTH
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SOCIALIST
REPUBLIC OF VIET NAM
Independence - Freedom – Happiness
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No.
13/2010/TT-BYT
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Hanoi,
May 12, 2010
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CIRCULAR
GUIDING
THE MANAGEMENT OF QUICK FOOD TEST KITS
Pursuant to the July 26, 2003
Ordinance on Food Hygiene and Safety:
Pursuant to the Government's Decree No. 163/2004/ND-CP of September 7, 2004.
detailing a number of articles of the Ordinance on Food Hygiene and Safety;
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;
The Ministry of Health guides the management of quick food test kits as
follows:
I. GENERAL PROVISION
Article 1. Scope of
regulation
1. This Circular stipulates the
assay, circulation registration, advertisement, labeling and use of quick food
test kits.
2. Before circulation in
Vietnam, all quick food test kits, produced at home and produced overseas and
imported into Vietnam (excluding those temporarily imported for re-export),
must be granted circulation registration certificates and numbers by the
Ministry of Health for testing food hygiene and safety assessment indicators.
Article 2. Subjects of
application
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Article 3. Interpretation of
terms
In this Circular, the terms
below are construed as follows:
1. A quick food test kit
consists of tools, chemicals or culturing media which are ready-made and
complete for testing one or several given food hygiene and safety indicators
and giving a result within a shorter time compared to standard testing methods.
2. Circulation registration
means a process of carrying out prescribed procedures for appraising the
scientificity. practicality and preciseness of a quick test kit and the
lawfulness of the dossier of request for registration in order to permit
circulation by issuing a circulation registration certificate and number.
3. Assay means a process of
experimentation to prove the actual properties of a quick food test kit.
Article 4. Charge and fee for
circulation registration of quick food test kits
Enterprises shall pay charges
and fees when registering for the circulation of quick food test kits under
regulations of the Minister of Finance.
II. ASSAY OF QUICK FOOD TEST
KITS
Article 5. Assay requirements
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2. No re-assay is required for
quick food test kits already accredited by WHO. FAO or JECFA or permitted for
circulation by countries which have signed protocols on mutual recognition with
Vietnam.
Article 6. Assay agencies
All technical units meeting
conditions stipulated in Article 7 of this Circular may technically assay quick
food test kits at the request of enterprises.
Article 7. Conditions on
assay agencies
To conduct assay, an agency must
meet the following conditions:
1. Having the function of
testing food hygiene and safety;
2. Having a laboratory
recognized to comply with ISO/IEC 17025 standards and operating in a domain in
which it is recognized to have conducted food tests related to indicators to be
assayed:
3. Having adequate equipment and
professional personnel meeting assay requirements.
Article 8. Procedures for
conducting assay
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2. Enterprises shall bear all
assay expenses under law.
3. Enterprises shall send to the
Ministry of Health (the Food Safety Administration) written requests for
consideration of assay results, enclosed with results of assays conducted by
three technical units selected by themselves from the list of technical units
annually announced by the Ministry of Health under Clause 1 of this Article.
4. After receiving complete
dossiers stated in Article 10 of this Circular, the Food Safety Administration
shall form an appraisal council to evaluate quick food test kits for advising
the Director of the Food Safety Administration on considering and signing
circulation registration certificates.
III. CIRCULATION REGISTRATION
FOR QUICK FOOD TEST KITS
Article 9. Forms of
circulation registration
1. Circulation registration:
Enterprises shall submit dossiers of request under Clause 1 or 2. Article 10 of
this Circular.
2. Registration of change or
addition:
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 addition 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 1 or 3. Article 10 of this Circular: the registration
certificate-issuing agency shall consider keeping unchanged the circulation
registration number and renewing the circulation certificate:
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- Change of the life time or
preservation conditions;
- Change (addition) of label
contents:
- Change of name of the kit;
- Change of scope of
application;
- Change of limit of finding;
- Change (addition) of use
instructions:
- Change of information on
preciseness (or error);
- Change (addition) of
composition of the kit and packaging specifications.
c/ When changing or adding 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 or 2, Article 10 of this Circular; registration
certificate-issuing agencies shall withdraw the issued permits and registration
numbers and carry out procedures for considering the issuance of new ones:
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- Change of operational
principles:
- Change of testing
characteristics.
Article 10. Dossiers of
request for circulation registration and registration of change or addition
1. An enterprise shall submit to
the registration certificate-issuing agency 2 sets of dossier of request for
circulation registration (below referred to as dossier). In such dossier,
documents of legal validity must be originals or lawful copies while
foreign-language documents must be accompanied by Vietnamese translations
already consularly legalized or notarized. A dossier must have a list of
documents.
2. A dossier of request for
circulation
registration of a quick food lest kit comprises:
a/ A written request for
circulation registration of a quick food lest kit (made according to a set
form);
b/ The business registration
certificate:
c/ Documents on researches and
tests related to the kit;
d/ User manual attached to the
kit;
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f/ Specimen labels of the kit.
including the label directly on the smallest packaging unit and the label on
the indirect package:
g/ The certificates of
protection of the trademark and intellectual properly rights, and the paper of
authorization by the manufacturer (if any):
h/ The permit for circulation in
the manufacturing or exporting country, issued by a competent state agency of
this country (for registration of imported kits);
i/ Three kits requested for
circulation registration.
3. A dossier of request for
change or addition of a registered content of a quick food test kit comprises:
a/ A written request for change
of a registered content of a kit (made according to a set form).
b/ Documents related to the
change or addition of the registered content.
c/ Three kits requested for
circulation registration.
Article 11. Competence and
procedures for considering the issuance of certificates and circulation
registration numbers for quick food test kits
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2. The Food Safety
Administration shall:
a/ Receive dossiers of request
for registration;
b/ Form an appraisal council to
evaluate the kit:
- To examine and evaluate 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 dealing
with the request for 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
kit by issuing a circulation registration certificate (according to a set form)
to the kit or renewing its certificate (for cases of change or addition);
- 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 lo the enterprise, clearly stating
the reason.
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- Thirty working days from the
date of issuing a paper of appointment for receiving replies, for requests for
circulation registration;
- Fifteen working days from the
date of issuing a paper of appointment for receiving replies, for requests for
change or addition of registered contents.
3. A circulation registration
certificate for a quick food test kit is valid for 5 years from the date of its
signing. Three months before the certificate expires, an enterprise that wishes
to make re-registration for further circulation in Vietnam shall submit a
dossier for this purpose. Past six months from the date of expiration of this
certificate, an enterprise that fails to submit a dossier for re-registration
shall compile a dossier as in the case of new registration.
IV. TRADING IN.
ADVERTISMENT.LABELING AND USE OF QUICK FOOD TEST KITS
Article 12. Trading in quick
food test kits
1. Enterprises may trade in
quick food test kits only after they obtain a circulation registration
certificate.
2. Enterprises may only trade in
quick food test kits of registered types that meet registered criteria.
3. Enterprises shall take
responsibility for any harm caused by their quick food test kits that fail to
meet registered criteria.
Article 13. Advertisement of
quick food lest kits
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2. Advertisements on quick food
test kits must comply with the advertisement law.
Article 14. Labeling of quick
food test kits
1. Labels of quick food test
kits must comply with the current law on labeling of domestically circulated
goods and imports and exports.
2. In addition, the compulsory
contents of a label arc:
a/ Circulation registration
number:
b/ Safety cautions in the
circulation and use of the kit.
Article 15. Use of quick food
test kits during the time of food hygiene and safety experimentation
Depending on the scope of
application, quick food test kits may be used in the following cases:
1. Testing in support of food
hygiene and safety examination and inspection work. Results of tests using a
quick food test kit are just initial, helping screening and orienting
subsequent affirmative tests in a laboratory. Results obtained from tests using
a quick food test kit may not be used as a basis for handling violations:
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3. Testing to help consumers
select food.
Article 16. Termination of
circulation
1. Circulation of a quick food test
kit shall be terminated under decision of the registration certificate-issuing
agency when an enterprise commits any of the following violations:
a/ Changing or adding a content
specified in Article 9 of this Circular without approval of an administration
agency;
b/ Advertising information on a
quick food test kit not true to the registered contents;
c/ The quick food test kit
circulated on the market is different from the registered sample or does not
have registered properties.
2. The circulation registration-issuing
agency shall decide to terminate circulation of the quick food test kit and
announce its decision nationwide.
3. Upon receiving the
circulation termination decision, an enterprise shall:
a/ Take without delay measures
to recall the kits currently circulated on the market: from its agents and
customers:
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c/ Report on recall results to
the administration agency.
4. For a serious violation that
affects product quality, the state management agency may consider withdrawing
the circulation registration number.
5. An enterprise shall bear all
expenses for recalling its quick food test kits.
V. IMPLEMENTATION PROVISIONS
Article 17. This Circular
takes effect on July 1.2010.
The Health Minister's Decision
No. 18/2007/ QD-BYT of February 27. 2007. on the management of quick food
hygiene and safety tests, ceases to be effective on the effective date of this
Circular.
Article 18. The Chief of
the Office, the Director of the Food Safety Administration, the chief inspector
and concerned units under the Ministry of Health, directors of provincial-level
Health Departments, health agencies within all branches, and concerned agencies
shall implement this Circular.-
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