CircularNo.29/20UffT-BYTofJune 30, 2011, on management of …extwprlegs1.fao.org/docs/pdf/vie107408.pdf · 2013-03-26 · invesbn.n+ certificate of the unit bottling or packagi~it.....
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OFFICIAL GAZE.TTE Issue nos06·07/July 2011(Cong BaD nos 425-426/July 28,2011)
Circular No. 29/20UffT-BYT of June30, 2011, on management ofinsecticidal or germicidal chemicalsand preparations for hnusehuld andmedical use
Pursuant to the Government's Decree No.
18812007/ND-CP of December 27, 2007,-defi"ill('7he junctions, tasks, powers and
organiz!f1i.onal structure of the Ministry of
Health;·
PUrslt!!!;t to the November 21,2007 Law on
Chemicallf;
PursfJ'!!'1f to theNovember 21,2007 Law on
Produet-:;"d Goods QUit/ity;
PursJtf!ht to the June 14, 2005 Commercial
Law;
PursEt to the Government's Decree No.
1081200~D-Cr ofOctobel' 7,2008, detailing
and gUitb' a number ofarticles ofthe Law on
Chemic-MM
PUNI)fJ(lffllt to the Government's Decree No.
26120llitm-CP ofApn'18, 2011. amendingand
supple~ting a number of articles of the
Govemmetu's Decree No. 10812008/ND·CP ofUctobeR-:- 2UU8, detailing and guiding a
~
number~rticles of the Law on Chemicals;
pur'!U?!ht to the Government's Decree No.
.J3212008/ND-CP of December 31, 2008,
detailing and guiding the Law on Product arui
Goods Quality;
Pursuant to the Government's Decree No.
12I2oo6/ND-CP ofJanuary 23,2006, detailing
the Commercial Law regarding international
goods trading and goods sale and purchaseagency, processing and transit with foreign
countries;
At the proposal oj the director ofthe Heauti
Environment Management Agency - the
Ministry ofHealth,
Chapter I
GENERAL PROVISIONS
Article 1. Scope of regulation
This Circular provides the circulation
registration; testing and assay; import, export
and circulation of insecticidal and germicidal
chemicals and preparations for household and
medical use in Vietnam.
Article 2. Interpretation of tenus
In this Circular, the terms below are
construed as follows:
1.Active ingredient means a substance with
active insecticidal or germicidal properties.
2. Insecticidal or germicidal chemical means
a product containing active ingredients in a
technical fonn for processing into preparations
or for direct use (below referred to as chemical).
Issue nos OS.07/July 2011(Gong Bao nos 425·4261July 28, 2011)
OFFICIAL GAZETTE 39
or preparations with valid circulation
registration numbers;
dI It is prohibited to use the names of active
ingredients of chemicals or preparations astheirtrade names;
el It is prohibited to give chemicals or
preparations trade names with me;mingsirrelevant to their effects and safety;::
2.Trade names may only be cha~ upon:
aI Exportation of home-made ch~caJ.Sand• •
preparations with valid circulation ~trationnumbers; .,.
Dossiers of request for permissioeeechange
trade names and the dossier-appra~g ordercornpl y with the law on certificates §gree sale
for imported and exported products~ goods;
bl Issuance of written conclusiou:!Jy a state
agency in charge of intellectual pr~ty or acourt on trademark infringcmcnts~volving
chemicals or preparations with valid-;:Culation
registration numbers.
Article 3. Lists of chemicals and
preparations
I. Lists of chemicals promulgated by the
Ministry of Health include:
Chapterll
CIRCULATION REGISTRATION FORCHEMICALS AND PREPARATIONS
a/ List of ohe.micals permitted for liSP
registration;
bl List of chemicals permitted for registrationfor restricted use;
cl List of chemicals banned from use.
2. Grounds for promulgation of lists of
chemicals:
aJ Recommendations of the World Health
Organization;
bl Scientific research Iindlngs approved by
competent authorities;
cl Information on chemicals and
preparations released by ministries and sectors.
Article 4. Trade names of chemicals andpreparations
I. Trade names of chemicals andpreparations shall begiven under the following
regulations:
<J! FOI each chemical or preparation of a
single producer, only one trade name may beregistered in Vietnam;
bl It is prohibited to use a single trade name
for two or more chemicals or preparations of asingle producer;
cl Trade names of chemicals or preparationsmust not be identical with those of chemicals
Article 5. Circulation registrantc
1. Units eligible to curry out 4Wculation
registration for chemicals and pr_rationsinclude:
al Vietnam-based organ izasions andindividuals that are owners (pro~ers) ofchemicals or preparations. Owners~ are not
producers of chemicals or preparations musthave documents proving their rights to own
such chemicals or preparations;
bl Vietnam-based organizations andindividuals that produce or trade in chemicals
or preparations or Vietnam-based permanentrepresentative offices of foreign enterprises
lSI VIETNAM LAW & LEGAL fORUM
OFFICIAL GAZETTE Issue nos OS.07/July 2011(Gong Bao nos 425-4261July 28, 2011)
which are authorized by chemical or preparation
owners to carry out the registration;
c/ Vietnam-based permanent representative
offices of foreign chemical or preparation
producers.
2. In case chemical or preparation owners
permit the unit they authorize to carry out theregistraGn of chemicals or preparations to
further ~t the authorization to another unit,they 5~c1early indicate such pcrrnission in
the autl$zation paper.
3. In"ellse a chemical or preparation owner
authori~woor more units in Vietnam to carry
out re~ration for a single chemical orpreparart'On, the Ministry of Health (the Health-Envirorpent Management Agency) shall onlyaccept~ process the complete and valid
dossie~ichis first submitted.
ArtiHti 6. Forms of circulation regisu atiou
1.o!ial registration applies to:
aI ~icals and preparations which are
newlypiitluced in the country;--b/ C~icals and preparations which have
been ~itted for use in foreign countries but
are im~ted for the first time for use inVietnarJf'"""l
cI cM!1nicals and preparations which have~
beeng~ed circulation registration numbers
but see cuanges in the form of product, solvents,
additives or contents of acti ve ingredients:
dJ Chemicals and preparations which have
been granted circulation registration certificatesbut are not re-registered within the time limit
specified in Clause 2,Article 9 of this Circular.
2. Additional registration applies to
chemicals and preparations with valid
circulation registration numbers which see:
a! Change in packagillg specifications:
bl Change in the form or contents of
specimen labels;
cI Change in the address of the producer or
registrant;
dJ Change in the right to own the circulation
registration certificate;
el Supplementation of a new production
establishment to the officially registered one;
fI Domestic bottling or packaging in
replacement of overseas bottling or packaging;
g/ Change in effects, quality criteria or use
methods.
3. Rc-rcgistration applies to chemicals and
preparations which have been granted
circulation registration certificates with
circulation registration numbers to be about to
expire under Clause 2, Article 9 of this Circular.
Article 7. Dossiers of official circulation
registration
1. A dossier of official registration for
circulation of a home-made chemical orpreparation comprises the following documents:
aJ A written request for official circulationregisuatlon (made according to a set form - not
printed herein);
bl The registrant's business registration
certificate, investment certificate or
establishment license, for registrants beingrepresen tative offices;
Issue nos OS-OJ/July 2011(Gong Bao nos 425·4261July 28,2011)
OFFICIAL GAZETTE 45
granted only one circulation registration number.
2. The circulation registration number of a
chemical or preparation shall be granted in the
fOM ofcirculation registration certificate which
is valid for 5 (five) years from the date of issue.
The circulation registration certificate shall
be made according to a set form.
Article 14. Cases subject to revocation of
circulation registration number
1. Registrants have forged registration
dossiers.
2. The chemicals ur preparations in circulation
are unconformable with the granted circulation
registration certificates or registration dossiers:
labels of the chemicals or preparations in
circulation are unconformable with those
approved by the Ministry of Health (the Health
Environment Management Agency) and
registrants fail to take remedies at the request of
competent state management agencies.
3. Reg istran ts lease or lend the II' c ircularion
registration certificates; or modify their
circulation registration certificates without
permission.
4. Registrants terminate chemical or
preparation production or trading activities.
5. Registrants no longer satisfy the
conditions for registration for circulation of
chemicals or preparations.
6. The chemicals or preparations in
circulation no longer assure the effects and
safety requirements as indicated in their dossiers
registered with the Ministry of l Icalth (the
Health Environment Management Agency).
Article 15. Charges for appraisal of
circulation registration dossiers
1. Organizations and individuals requesting
circulation registration Of assay of chemicals or
preparations shall pay dossier appraisal charges
according to the law on charges and fees.
2. Dossier appraisal charges shall be paidupon dossier submission to the Ministry of
Health (the Health Environment Mtmigement
Agency).
Chapter III
TESTING AND ASSAY OF CHEMICALSAND PREPARATIONS
Section [
TESTING OF CHEMICALS~D
PREPARATIONS
Article 16. Cases SUbject to testDj:
1. Chemicals and preparatiOl:i5.jjrior to
official circulation registration.
2. Chemicals and preparations oorrently in
circulation in Vietnam.
Article 17. Testing contents
I. Testing of chemicals or prepaMtlonS fOT
circulation registration covers the idf;tification........of the content and composition. of activeingredients of these chemicals or p~rations.-2. Testing of chemicals or p~arations
currently in circulation covers the identification
of the composition and content of main active
ingredients and other quality criteria of thesechemicals or preparations. The testing of
chemicals and preparations currently in
circulation complies with the Law on Product
and Goods Quality and other laws.
e VIETNAM LAW & LEGAL FORUM
46 OFFICIAL GAZETTE Issue nos06-07/Julv 2011(Cong Bao nos 425-4261July 28, 2011)
Article 18. Testing units
I. Units which are set up under Vietnamese
law and have the function of testing the
composition and content of chemicals and
preparations.
2. In case Vietnam-based testing units are
unable to test the content and composition of
chemicG or preparations requested for
registrasen, the Ministry of Health (the Health
Envicvellt Management Agency) may
consideG..tnd accept testing results of their
produceQr an independent lab, and registrants
shall tag: responsibility before law for the
lawfulnG8 of testing results they produce.
Section 2
ASSA'[oP CHEMICALS AND TESTING
Artie 19. Cases subject to assay
1. C&nicals and preparations prior to
offICial _ulation registration.
2. CUlicals and preparations with valid
circulati~registration numbers granted by the
MiDist~f Health (the Health Environment--ManagE!rn@ntAgency) requested for additional
• •cin;:Ula[~egis[raLiun under Points e, for g,
ClauseUrticle 6 of this Circular.
3. ~llicals and preparations with the
circulation registration numbers granted by the
Ministry of Health (the Health Environment
Management Agency) to be about to expire
requested for circulation re-registration under
Point b, Clause 2, Artie Ie 9 of this Circular.
4. Chemicals and preparations without
cieculatiulllegi:-.ttatiulllluJIloers tu be imported
in large volumes for exterminating insects or
bacteria on board aircraft.
Article 20. Assay contents
1.Assessment of the effects of chemicals or
pte parat i un» La wards La! geteu objec LoS as
requested by registrants.
2. Assessment of the safety for:
aJ Persons directly assaying chemicals or
preparations, in case of laboratory assay;
bl Persons directly assaying chemicals or
preparations and persons living in assay areas,in case of field assay.
Article 21. Assaying units
1. Units assaying the safety and effects of
insecticidal chemicals and preparations:
aJ The National Institute of Hygiene and
Epidemiology;
b/The Pasteur Institute of Ho Chi Minh City;
cl The Pasteur Institute of Nha Trang;
d/ The Central Highlands Institute of
Hygiene and Epidemiology;
e/ The National Institute of Mala! iulogy,
Parasitology and Entomology;
flThe Institute of Malariology, Parasitology
and Entomology of Ho Chi Minh City;
fl The Institute of Malariology. Parasitologyand Entomology of Quy Nhon.
2. Units assaying the safety and effects ofgermicidal chemicals and preparations: