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THE PRIME MINISTER
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SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No. 42/2013/QD-TTg
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Ha Noi, July 15, 2013
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DECISION
PROVIDING THE MANAGEMENT OF DRUGS FOR HUMAN USE
WHICH ARE IMPORTED AND EXPORTED THROUGH NON-COMMERCIAL CHANNEL, AND AMENDING
AND SUPPLEMENTING A NUMBER OF ARTICLES OF THE REGULATION ON IMPORT OF DRUGS
WITHOUT REGISTRATION NUMBERS IN VIETNAM PROMULGATED TOGETHER WITH THE PRIME
MINISTER’S DECISION NO. 151/2007/QD-TTG OF SEPTEMBER 12, 2007
Pursuant
to the December 25, 2001 Law on Organization of the Government;
Pursuant
to the June 14, 2005 Law on Pharmacy;
Pursuant
to the December 9, 2000 Law on Drug Prevention and Control and the June 3, 2008
Law Amending and Supplementing a Number of Articles of the Law on Drug
Prevention and Control;
Pursuant
to the Government’s Decree No. 58/2003/ND-CP of May 29, 2003, prescribing the
control of import, export and transit via Vietnamese territory of narcotic
substances, pre-substances, addictive drugs and psychotropic drugs;
At
the proposal of the Minister of Health,
The
Prime Minister prescribes the management of drugs for human use which are
imported and exported through non-commercial channel, and amendments and
supplementations to a number of articles of the Regulation on import of drugs
without registration numbers in Vietnam promulgated together with the Prime
Minister’s Decision No. 151/2007/QD-TTg of September 12, 2007.
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1.
Drugs imported and exported through non-commercial channel prescribed in this
Decision include:
a/
Donations and gifts which are given by overseas organizations and individuals
to organizations and individuals in Vietnam, or by organizations and
individuals in Vietnam to overseas organizations and individuals;
b/
Goods of diplomatic missions and international organizations in Vietnam and
employees of these missions and organizations;
c/
Personal luggage of persons on entry or exit which are consigned with bills of
lading and carry-on baggage of persons on entry.
2.
Drugs eligible for non-commercial import and export may be imported and
exported only for use by persons on entry or exit, their families or employees
of organizations importing and exporting drugs through non-commercial channel
as specified in Clause 1 of this Article.
3.
Quotas of drugs permitted for non-commercial import and export:
a/
The quantities of finished addictive drugs being carry-on baggage of persons on
entry or exit must not exceed the quantities written in enclosed doctor
prescriptions or the dose indicated for 7 days;
b/
The quantities of finished psychotropic drugs and pre-substances used for drug
production which are imported and exported through non-commercial channel must
not exceed the quantities written in the enclosed doctor prescriptions or the
dose indicated for 10 days;
c/
Other finished drugs are permitted for non-commercial export in unlimited
quantities and consignments or carry-on baggage; are permitted for
non-commercial import provided that the total import value does not exceed USD
100 (one hundred US dollars) each time and that each individual or organization
receives drugs no more than 3 times a year;
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4.
The Ministry of Health shall specify dossiers for non-commercial import or
export of drugs specified at Points a, b and c, Clause 3 of this Article, and
dossiers, order and procedures for grant of licenses for non-commercial import
or export of drugs specified at Point d, Clause 3 of this Article.
5.
Drugs banned from non-commercial import and export include:
a/
Materials used for drug production;
b/
Finished drugs containing active ingredients which are on the Ministry of
Health’s
list of active ingredients banned from import and export.
Article
2. To amend and supplement a number of
articles of the Regulation on import of drugs without registration numbers in
Vietnam promulgated together with the Prime Minister’s Decision No.
151/2007/QD-TTg of September 12, 2007, as follows:
1.
To amend and supplement Article 3 as follows:
“Article
3. Principles of managing drugs without registration numbers which are imported
into Vietnam
1.
Finished drugs without registration numbers may be imported under import
license. Such a license is valid for one year at most after its signing.
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3.
Materials used for drug production without registration numbers which are
imported for production of drugs with valid registration numbers while the list
of materials used for drug production prescribed in Clause 2 of this Article
has not yet been publicized may be imported under import licenses. Such a
license is valid for 2 years at most after its signing.
4.
The Minister of Health shall guide the dossiers, order and procedures for grant
of import licenses for drugs without registration numbers, and the order and
contents of publicization of the list of materials used for drug production
which are permitted for import without licenses.”
2.
To add the following Clause 2 to Article 4:
“2.
Enterprises not yet granted drug production eligibility certificates may import
materials used for drug production in order to produce drugs on a trial basis
with quantities suitable to the expected production scale. Trial products may
be used for research purpose only and may not be circulated and used for
humans.”
3.
To add the following Point dd to Clause 2, Article 6:
“dd/
For rare drugs and drugs for therapeutic demands of hospitals in special cases
and with a use duration of 24 months or more, their remaining use duration must
be at least 12 months counting from the date they arrive at a Vietnamese port.
For drugs with a use duration of less than 24 months, their remaining use
duration must equal at least one third of their use duration counting from the
date they arrive at a Vietnamese port.”
4.
To amend and supplement Article 10 as follows:
“Article
10. For materials used for drug production without registration numbers
1.
Materials used for drug production without registration numbers permitted for
import into Vietnam include:
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b/
Materials used for drug production without registration numbers for research
and testing purposes which are used only for research and testing purposes with
quantities sufficient for such purposes;
c/
Materials used for drug production without registration numbers which are
imported for use as samples registered for circulation in Vietnam with
quantities of each kind sufficient for testing purpose.
2.
Imported materials used for drug production must be subject to quality
standards and have quality according to the standards written in import orders
or registered in drug registration dossiers.
3.
Materials used for drug production on the list of addictive drugs, psychotropic
drugs and pre-substances used for drug production without registration numbers
must comply with this Decision and the Ministry of Health’s regulations guiding
activities relating to addictive drugs, psychotropic drugs and pre-substances
used for drug production, and other relevant regulations.
Article
3. Transitional provisions
1.
Dossiers of request for non-commercial import and export of drugs which are
submitted before the effective date of this Decision comply with the Prime
Minister’s Decision No. 71/2002/QD-TTg of June 7, 2002, on management of
curative drugs for human use imported and exported through non-commercial
channel.
2.
Dossiers of application for import licenses for drugs without registration
numbers which are submitted before the effective date of this Decision comply
with the Prime Minister’s Decision No. 151/2007/QD-TTg of September 12, 2007,
promulgating the Regulation on import of drugs without registration numbers in
Vietnam.
3.
Import licenses for materials used for drug production without registration
numbers which are granted before the effective date of this Decision will be
valid till their expiration date.
Article
4. Implementation responsibility and
effect
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The
Prime Minister’s Decision No. 71/2002/QD-TTg of June 7, 2002, on management of
curative drugs for human use imported and exported through non-commercial
channel, ceases to be effective on the effective date of this Decision.
The
Ministry of Health shall promulgate documents guiding the implementation of
this Decision.
Ministers,
heads of ministerial-level agencies, heads of government-attached agencies and
chairpersons of provincial-level People’s Committees shall implement this
Decision.-
FOR THE PRIME MINISTER
DEPUTY PRIME MINISTER
Nguyen Thien Nhan