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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.
04/2008/TT-BYT
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Hanoi,
May 12, 2008
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CIRCULAR
GUIDING THE LABELING OF MEDICINES
Pursuant to June 14, 2005
Pharmacy Law No. 34/2005/QH11;
Pursuant to the Government's Decree No. 89/ 2006/ND-CP of August 30. 2006,
stipulating the labeling of goods;
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;
Pursuant to the Ministry of Science and Technology's Circular No.
09/2007/TT-BKHCN of April 6, 2007, guiding the implementation of a number of
articles of the Government's Decree No. 89/2006/ND-CP of August 30, 2006,
stipulating the labeling of goods;
The Ministry of Health guides the labeling of medicines as follows:
Part I
GENERAL PROVISIONS
1. Scope of
regulation
a/ This Circular guides contents
and methods of labeling medicines circulated in Vietnam, exported and imported medicines.
b/ Labels of medicines
temporarily imported for re-export, medicines imported on a noncommercial basis
and aid medicines, and labels used in the process of research and manufacture
of medicines in manufacturing establishments are not governed by this Circular.
c/ Labels of medicines that need
to be imported in emergency circumstances or other special cases are subject to
specific regulations issued by the Ministry of Health on a case-by-case basis.
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This Circular applies to
organizations and individuals that manufacture, trade in. import or export
medicines in Vietnam.
3.
Interpretation of terms
a/ Medicine means a substance or
mixture of substances for human use for the purpose of preventing, curing or
diagnosing disease or correcting physiological functions of human bodies, and
may take the form of finished medicine, medicine material, vaccine or medical
biological, except for functional food.
b/ Medicine label means
handwritten, printed or drawn letters, drawings, images and signs printed in
inlay or relief directly on commercial packages of medicines or sheets bearing
such letters, drawings, images and signs securely stuck, pinned or attached
thereto in order to display essential information on medicines, helping consumers
choose and use proper medicines and serving as a oasis for functional agencies
to conduct inspection, supervision and management.
c/ Medicine labeling means the
presentation of basic and necessary information on a medicine on its label.
d/ Original label of a medicine
means the first label printed or securely stuck, pinned on or attached to the
commercial package of the medicine after the packaging step in the
manufacturing chain is completed.
e/ Auxiliary label means a label
bearing mandatory contents in Vietnamese, which are translated from those
appearing on an original label in a foreign language and added with other
mandatory contents in Vietnamese which are absent from the original label as
required by law.
f/ Commercial package of a
medicine means a package containing the medicine and circulated together with
the medicine. Commercial packages of medicines are divided into two kinds:
- Immediate packages, which
contain and are in direct contact with medicines;
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g/ Proprietary medicine means a
medicine with a trade name given by its manufacturer and different from its
original or international nonproprietary name.
h/ Medicine circulation means activities
of displaying, transporting and storing medicines in the course of medicine
trading.
i/ Name and address of
organization or individual responsible for a medicine means name and address of
an organization or individual manufacturing, importing, exporting or entrusting
import or export of the medicine.
j/ Packaging specification of a
medicine means the quantity of medicine in net weight, net volume or cardinal
number.
k/ Manufacture batch number
means a sign in numerals or letters or a combination of numerals and letters to
identify a medicine batch and facilitate the tracing back of the historical
record of a medicine batch, covering all stages of the manufacturing process,
quality control and distribution of the medicine batch.
1/ Manufacturing date means a
point of time at which a medicine batch is completely manufactured, processed,
bottled, packaged or otherwise finished:
m/ Expiry date of a medicine
means a point of time fixed for a medicine batch after which the medicine
should not be used.
n/ Medicine origin means a
country or territory where the medicine is wholly manufactured or where the
last stage of substantial processing of the medicine is carried out when more
than one country or territory jointly participate in the manufacture of the medicine.
o/ Use instruction of a medicine
means necessary information guiding users how to use medicine effectively,
safely and properly.
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4. Medicines
subject to compulsory labeling
a/ Domestically circulated
medicines: imported or exported medicines must be labeled under this Circular,
except for the cases specified at Point b of this Clause.
b/ In case foreign organizations
or individuals importing Vietnamese medicines request labeling under purchase
and sale contracts and take responsibility for their requests, exporting
organizations or individuals may comply with these requests on the condition
that these requests neither misrepresent the nature of medicines nor violate
the laws of Vietnam and importing countries.
5. Location
of medicine labels
Medicine labels must be attached
to commercial packages of medicines at places where all required contents of
labels are easy to see without having to take the medicines to pieces.
6. Size of
medicine labels
Organizations and individuals
responsible for labeling medicines may decide by themselves on sizes of labels
but shall ensure that mandatory contents fully appear on labels and are easy to
see with the naked eyes.
7. Colors of
letters, symbols and images on medicine labels
Colors of letters, numerals,
drawings, images, signs and symbols appearing on medicine labels must be
conspicuous. Letters and numerals in mandatory contents must be in colors in
contrast to background colors of the labels.
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a/ Mandatory contents appearing
on medicine labels must be in Vietnamese, except for the cases specified at
Point d of this Clause.
b/ For domestically manufactured
and circulated medicines, apart from complying with the provisions of Point a
of this Clause, contents of labels may be in both Vietnamese and another
language. Contents in another language must be consistent with Vietnamese
contents. The font size of letters of another language on a label must not be
larger man that of Vietnamese letters on the same label
c/ For medicines imported into
Vietnam, if their original labels do not bear or inadequately bear mandatory
contents in Vietnamese, they must have auxiliary labels bearing mandatory
contents in Vietnamese while original labels must be kept intact.
d/ The following contents may be
expressed in other languages using letters of Latin origin:
- Names of proprietary medicines,
original or international nonproprietary names of medicines:
- International nonproprietary
names or scientific names of ingredients and quantitative contents of medicines
in case it is impossible to translate these names into Vietnamese or their Vietnamese
translations are meaningless:
- Names and addresses of foreign
enterprises manufacturing, or licensing the manufacture of, medicines.
9.
Responsibility to label medicines
a/ Medicines manufactured for
domestic circulation shall be labeled by manufacturing organizations and
individuals.
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If medicines cannot be exported
and are returned for domestic circulation, organizations and individuals that
put these medicines into circulation shall label them under the provisions of
this Circular.
c/ For medicines imported into
Vietnam with original labels incompliant with the provisions of this Circular,
importing organizations and individuals shall make auxiliary labels under the
provisions of Point c, Clause S. Part 1 of this
Circular before putting them
into circulation and keep intact their original labels.
d/ Contents of medicine labels.
including also auxiliary labels and use instruction inserts, must be truthful,
clear and accurate, and do not mislead the nature of the medicines.
10.
Compliance with intellectual property regulations
Medicine manufacturers and
traders shall comply with legal provisions on intellectual property and take
responsibility before law for intellectual property issues related to contents
of medicine labels.
Part II
CONTENTS OF MEDICINE
LABELS
Section A.
LABELS OF ORDINARY MEDICINES
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A medicine label must bear all the
following mandatory contents:
a/ Name of the medicine:
b/ Active ingredients and their
contents or concentrations:
c/ Packaging specifications:
d/ Indications, administration,
contraindications:
e/ Preparation form,
registration number or import permit or manufacture batch number, manufacturing
date. expiry date, storage conditions:
f/ Remarkable signs:
g/ Name and address of
organization or individual responsible for the medicine;
h/ Origin of the medicine:
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If it is impossible to display
all above mandatory contents, the medicine label must bear those contents
specified at Points a, b, e and h of this Clause. Other mandatory contents must
appear on an auxiliary label or a use instruction insert, and the medicine
label must indicate where these contents are displayed.
2.
Optional contents of medicine labels
Apart from the mandatory
contents specified in Clause 1, Section A. Part II of this Circular, other
contents may be displayed on medicine labels. These optional contents must be
truthful and accurate and neither mislead to the true nature and effect of the
medicine nor misrepresent other contents of the label.
Section B.
LABELS OF SPECIAL MEDICINES
1. Labels
of materials
a/ A label of a medicine
material must bear the following contents:
- Name of the material;
- Content or concentration (if
any);
- Standard of the material;
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- The manufacture batch number
or the manufacturing date;
- Expiry date and storage
conditions:
- Registration number (if any);
- Name and address of the
manufacturer, origin of the medicine;
- Name and address of the
importer (for imported materials).
b/ Labels of materials for
manufacturing habit- forming medicines must bear the word "gay
nghien" (habit forming). Labels of materials for manufacturing
psychotropic medicines must bear the word "huong tarn than"
(psychotropic). Labels of materials for manufacturing medicines being
pre-substances must bear the phrase "tien chat dung lam thuoc"
(pre-substance for use as medicine).
The words and phrase "gay
nghien," "huong tam than" and "tien chat dung lam
thuoc" must appear in bold letters in a round box on the upper right comer
of medicine labels.
2. Labels
on medicine blister packs -
a/ A label on a medicine blister
pack must bear at least the following contents:
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- Active ingredients and their
contents: For a medicine being the mixture of not more than three active
ingredients, each of the active ingredients and its content must be indicated:
- The manufacture batch number
and expiry date;
- Name of the manufacturer,
which may be abbreviated but must ensure that the manufacturer is identifiable.
b/ Medicine blister packs must
have outer packages with labels bearing all the contents specified in Clause 1,
Section A, Part II of this Circular.
3. Labels
on small-sized immediate packages
a/A medicine label on an
immediate package of small size or special shape on which it is impossible to
fully display the mandatory contents specified in Clause 1. Section A. Part II
of this Circular, must bear at least the following contents:
- Name of the medicine;
- Active ingredients and their
contents: For a medicine being the mixture of not more than three active
ingredients, each of the active ingredients and its contents must be indicated:
- Volume or weight:
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- Name of the manufacturer,
which may be abbreviated but must ensure that the manufacturer's name is
identifiable.
b/The above immediate packages
of medicines must be enclosed in outer packages with labels fully displaying
the contents specified in Clause 1, Section A. Pan II of this Circular.
4. The
label of a medicine prepared on prescription must bear the following contents:
a/ Name of the medicine; b/
Active ingredients, their contents or concentrations;
c/ Date of preparation and
expiry date;
d/ Route of administration; e/
Name of patient; f/ Name of preparer;
g/ Name and address of medicine
preparing establishment.
5. Labels of medicines used in
national target health programs
a/ Labels of medicines used in
national target health programs must bear the mandatory contents specified in
Clause 1, Section A. Pan II of this Circular.
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Part III
METHOD OF LABELING
MEDICINES
1. Names
of medicines
a Names of medicines shall be
given by medicine manufacturers or traders. Names of medicines must not
misrepresent the nature and effect of medicines.
Names of medicines must appear
in bold and prominent letters on their labels.
For proprietary medicines being
pure substances, original or international nonproprietary names of pure
substances must immediately follow the names of proprietary medicines.
b/ Medicines may be named after:
- Their original names:
- Their international
nonproprietary names (INN)
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2. Active
ingredients, their contents or concentrations
a/ Active ingredients and the content
or concentration of each active ingredient must be indicated for the smallest
dividable dose or the smallest packaging unit. Active ingredients are indicated
under their original or international nonproprietary names.
For medicines made from pharmaceutical
materials: The Vietnamese names of medicaments must be indicated. For medicines
made from imported pharmaceutical materials without Vietnamese names, names of
medicaments in the languages of exporting countries must be indicated together
with their Latin names.
b/ Units of measurement
- Units of weight: To use gram
(g), milligram (mg), microgram (meg), or kilogram (kg) for medicines in
considerable weight;
- Units of volume: To use
milliliter (ml), or liter (1) for medicines in large volume;
- For a weight of under 1 mg or
a volume of under 1 ml. decimal numbers shall be used (for example: 0.25 mg;
0.5 ml);
- Units of strength may be used
for some special active ingredients under international regulations.
3. Packaging specifications
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b/ Packaging specifications of
medicines must be expressed in cardinal numbers.
c/ Specific methods of writing
packaging specifications for each form of medicine:
- For medicines in tablets or
pills: Write the number of tablets or pills. Particularly for solid pellets:
Write the net weight;
- For medicines in powder,
granular or ointment form: Write the net weight:
- For medicines in liquid form:
Write the net volume.
d/ If a commercial package of a
medicine contains many packaging units, the weight of each packaging unit and
the number of packaging units must be indicated.
e/ An outer package of a
medicine must contain a number of immediate packages appropriate to the
quantity of the medicine for a common treatment period.
This Point does not apply to
medicines supplied for hospitals but their outer packages must display the
phrase "medicine for use in hospitals."
4.
Indications, administration and contraindications (if any) of medicines
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b/ Administration must clearly
indicate route of administration, dosage and use time of medicines.
c/ For medicines with
contraindications, cases of contraindication must be clearly specified.
d/ Indications, administration
and contraindications may be displayed by either of the following methods:
- They are displayed directly on
commercial packages of medicines:
- If labels on outer packages
are too small to bear indication, administration or contraindication contents,
these labels must bear the phrase "indications, administration and
contraindications: see the use instruction insert" and there must be use
instruction inserts in the commercial packages of medicines.
5.
Preparation form, registration number, import permit number and manufacture
batch number, manufacturing date, expiry date and storage conditions
a/ Preparation form of medicines:
Write tablet, capsule, injection fluid, suppository, ete.
b/ Registration number means
signs granted by Vietnam's Ministry of Health (the Drug Administration of
Vietnam) to a medicine to certify that this medicine has been registered for
circulation in Vietnam: Write SDK: XX-XXXX-XX.
c/ Import permit number means
the serial number of a permit granted by the Drug Administration of Vietnam for
the import of a medicine without registration number: Write GPNK: XXXX/QLD-XX.
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- "So to san xuat"
(manufacture batch number): XXXX; or "So lo SX":XXXX.
The sequence of manufacture
batch numbers shall be decided by manufacturers themselves.
e/ Manufacturing date and expiry
date: Write these dates in the order: date, month, year of the calendar year.
Each number indicating a date or month or year is written in two numerals, but
the number indicating a year may be written in four numerals. Numbers
indicating the date, month and year of a point of time must be on the same
line.
- "Ngay san xuat"
(manufacturing date; and "han dung" (expiry date) on a label may be
written in full or in a shortened form in block capitals: NSX, HD.
For example:
- NSX: 050706: or NSX: 05072006;
or NSX 05/07/06 or NSX: 05/07/2006.
- HD: 050708; or HD: 05072008;
or HD: 05/ 07/08; or HD: 05/07/2008.
- If the manufacturing date and
expiry date are written in a foreign language on labels, on auxiliary labels
must be written: "Ngay san xuat" and "Han dung " or NSX and HD: see "Mfg. Date" and
"Exp. Date" on the package.
fl Storage conditions means
climatic factors which do not adversely affect the quality of medicines.
Necessary storage conditions for medicines must be specified on their labels.
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6. Remarkable signs
a/ For prescription medicines,
the sign "Rx" must be shown on the left corner above the medicine
name together with the phrase "Thuoc ban theo don" (to be dispensed
only on a doctor prescription).
b/ For injection medicines, the
route of administration must be clearly indicated. The route of administration
of a medicine may be written in abbreviations:"tb" for "tiem
bap" (intramuscular injection), "tdd" for "tiem duoi
da" (intradermic injection), "tm" for "tiem tinh much"
(intravenous injection).
c/ For eye drops, write the
phrase "thuoc tra mat" (eye drop).
d/ For nasal drops, write the
phrase "thuoc nho mui" (nasal drop).
e/ For medicines for external
use only, write the phrase "thuoc dung ngoai" (for external use
only).
f/ For medicines in phials for
oral use. write the phrase "khong duoc tiem" (not for injection).
g/ All labels must bear the
phrases "De xa tam tay tre em " (keep out of reach of children) and
"Doc ky huong dan su dung truoc khi dung " (read the instructions
carefully before use).
h/ Method of writing remarkable
signs:
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- If there are many remarkable
signs for a medicine, all these signs must appear on labels.
7. Names
and addresses of organizations or individuals responsible for medicines
a/ In the following specific
cases, write name and address of an organization or individual responsible for
a medicine as follows:
- For a domestically
manufactured medicine, write the name and address of the establishment
manufacturing this medicine:
- For a medicine imported for
circulation in Vietnam, write the following:
+ Name and address of the manufacturing
organization or individual, the country of manufacture:
+ Name and address (name of
province or city) of the importing organization or individual.
The name of the manufacturer
must be printed in a letter font size equal to or larger than that of the
importer's name.
- For a packaged medicine made
from semifinished products of another manufacturer, write the name and address
of the packaging establishment and the name of the semi-finished product
manufacturer;
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- For a medicine manufactured
under license from another organization or individual, write the phrase
"San xuat theo nhuong quyen cua:" (Manufactured under license from:)
(Name of the licensor) "tai:" (by:) (Name of the licensee) and the
address of the licensee.
The name of the licensee must be
printed in a letter font size equal to or larger than that of the licensor's
name.
- For a medicine manufactured
under processing contract, write the phrase "San xuat tai:"
(Manufactured by:) (Name of the processor "theo hop dong voi:" (under
the processing contract with:) (Name of the processed and the address of the
processor.
The processor's name must be
printed in a letter font size equal to or larger than that of the processee's
name.
b/ The name and address of a
distributor, if written on the label, must be in the same place with those of
the manufacturer and of a letter font size aqual to or smaller than that of the
manufacturer's name.
c/ The name of the organization
or the establishment of individual responsible for the medicine as defined at
Point a of this Clause written on the medicine label must be that stated in
regulatory documents on its foundation. The transaction name of this
establishment or organization may be additionally written but must be of a
letter font size not larger than that of its full name.
d/ Address of manufacturer,
packaging establishment, licensee or processor: Write house number, street
(village, hamlet), commune (ward, township), district (provincial town or
city), province (centrally run city).
e/ Names of organizations,
individuals and geographical areas must not be abbreviated.
8. Origin
of medicines
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b/ For a medicine made in
Vietnam for domestic circulation, for which the address of the manufacturer is
already written, its origin is not required to appear on the label.
c/ Origin of medicines must be
written on their outer packages and immediate packages.
9. Use instructions
of medicines
a/ For medicines subject to
compulsory labeling under this Circular, there must be use instruction inserts
in Vietnamese in their commercial packages (except for labels of medicine
materials or labels of prescription medicines).
The letter font size and color
of words printed on use instruction inserts must be large and conspicuous
enough so as the printed contents can be easily read with the naked eves.
b/ A use instruction insert for
a medicine must bear the following contents:
- Name of the medicine:
- Ingredients and formula of the
smallest dividable dose or the smallest packaging unit. The formula must
indicate all active ingredients and excipients in their original names or
international proprietary names. The content or concentration of each active
ingredient must be indicated but contents or concentrations of excipients are
not required to be written;
For medicines from
pharmaceutical materials: Vietnamese and Latin names of medicaments must be
written. For medicines made from imported pharmaceutical materials which have
no Vietnamese names, the pharmaceutical materials' names in the exporting
country's language and their Latin names must be written.
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- Packaging specification;
-Indications;
- Dosage and route of
administration: The amount of medicine to be taken per day and doses for
adults, children and aged people (if any) must be clearly indicated:
Route of administration, regimen
(for example: taken before or after meals), and way of taking the medicine in order
to get the best effect (for example: taken orally with a large water intake).
- Contraindications: Cases in
which the medicine must not be used must be specified:
-Precautions for medicine use:
Preventions and precautions for use of the medicine: special warnings for women
in pregnancy or lactation children, persons with chronic diseases, undesirable
effects on working people (operators of machines, drivers, etc.) must be
clearly written:
Interactions with other
medicines and other forms of interaction (for example: interactions with
alcohol, foods) which may reduce the medicine's effect:
- Undesirable effects:
Undesirable effects which may occur in the use of the medicine must be clearly
indicated with the phrase "Thong bao cho bac sy nhung lac dung khong mong
muon gap phai khi su dung thuoc" (Please report undesirable effects to
doctors).
Cases in which medicine use must
be stopped and cases which must be reported to doctors must be clearly
enumerated.
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- Overdose and remedies:
Manifestations of overdose and remedial and first-aid methods;
- Remarkable signs and warning:
Remarkable signs must be written according to the provisions of Clause 6. Part
III of this Circular.
The warning phrase "Doc ky
huong dan su dung truoc khi dung. Neu can. them thong tin xin hoi y kien bac
sy" (Read the use instructions carefully before use. For more information,
please consult doctors) must be written.
For prescription medicines, the
phrase "Thuoc nay chi dung theo don bac sy" (This medicine can be
used only on doctor prescriptions) must be written.
- Storage conditions: Necessary
storage conditions of the medicine must be clearly specified:
- Expiry date: Expiry
date of the medicine as specified at Point e. Clause 5. Part III of this
Circular or the shelf life from
the manufacturing date (for example: 24 months from the manufacturing date)
must be written.
For a medicine not yet divided
into doses, its shelf life (if any) counting from the time of opening its
immediate package must be written.
- Name and address of the
organization or individual responsible for the medicine.
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Auxiliary labels must be
attached to outer packages of medicines and must not hide contents of original
labels. Contents of auxiliary labels must not misrepresent contents of original
labels, and labeling organizations and individuals shall take responsibility
before law for the accuracy and truthfulness of additionally written contents.
Auxiliary labels are written as follows:
a/ If auxiliary labels are large
enough for the mandatory contents specified in Clause 1, Section A. Part II of
this Circular, write all these contents on labels.
b/ If auxiliary labels are too
small for all the mandatory contents, write at least the following contents:
- Name of the medicine;
- Active ingredients, their
contents or concentrations;
Name of organization or
individual responsible for the medicine (according to the provisions of Clause
7. Part III of this Circular);
- Registration number or import
permit number:
- Packaging specification:
- Manufacturing date, expiry
date, manufacture batch number.
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Other mandatory contents must be
written on the use instruction insert. In this case, the auxiliary label must
bear the phrase "Cac thong tin khac de nghi xem trong to huong dan su dung
kern theo" (For more information, please read the use instruction insert)
and the information in the use instruction insert, as referred to in the auxiliary
label, must be regarded as pan of the auxiliary label.
c/ If the following contents
appear on original labels in a language of Latin origin, they are not required
to be translated into Vietnamese and appear on auxiliary labels:
- Proprietary name, original name
or international nonproprietary name of the medicine;
- International nonproprietary
name or scientific name of each ingredient of the medicine in case it cannot be
translated into Vietnamese or its Vietnamese translation is meaningless:
- Name and address of the
foreign manufacturer or licensor.
Part IV
INSPECTION, EXAMINATION,
AND HANDLING OF VIOLATIONS
1.
Inspection and examination
a/ The Drug Administration of
Vietnam and the Inspectorate of the Health Ministry shall inspect and examine
according to their competence the implementation of this Circular by medicine
manufacturers and traders throughout the country.
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2. Handling
of violations
a/ Organizations and individuals
that manufacture, trade in, import or export medicines in Vietnam shall
strictly comply with the provisions of the Government's Decree No. 89/
2006/ND-CP of August 30. 2006. and the guidance in this Circular.
b/ Organizations and individuals
that violate legal provisions on medicine labels shall, depending on the nature
and severity of their violations, be administratively handled or examined for
penal liability. If causing damage, they shall pay compensations therefor in
accordance with law.
Part V
IMPLEMENTATION PROVISIONS
1. This Circular takes effect 90
days after its publication in "CONG BAO." To annul the Health
Ministry's Circulars No. 14/2001/TT-BYT of June 2,.2001, guiding the labeling
of medicines and cosmetics with direct impacts on human health, and No.
14/2000/TT-BYT of June 22, 2000, guiding the implementation of the Prime
Minister s Decision No. 178/1999/QD-TTg of August 30, 2000. on labeling of
vaccines and immuno-biological products.
2. Medicines labeled under the
Health Ministry's Circulars No. 14/2001/TT-BYT of June 26,2001. and No.
14/2000/TT-BYT of June 22,2000. which are marketed before the effective date of
this Circular, may continue being circulated until their expiry date.
3. The Drug Administration of
Vietnam, units attached to the Health Ministry and provincial/ municipal Health
Services, the Vietnam Pharmaceutical Corporation, pharmaceutical manufacturers
and traders, and licensed foreign pharmaceutical companies shall implement this
Circular.
4. Any problems arising in the
course of implementation should be promptly reported to the Health Ministry
(the Drug Administration of Vietnam) for study and solution.
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FOR THE
HEALTH MINISTER
VICE MINISTER
Cao Minh Quang