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MINISTRY OF HEALTH
DRUG ADMINISTRATION OF VIETNAM
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SOCIALIST REPUBLIC
OF VIETNAM
Independence - Freedom - Happiness
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No. 7043/QLD-TT
Re: guideline for implementation of Circular
No. 04/2008/TT-BYT dated May 12, 2008 on guideline for drug labeling
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Hanoi, July 17,
2008
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To:
- Provincial Departments of Health
- Producers and traders of drugs in Vietnam
On May 12, 2008, the Minister of Health
issued the Circular No. 04/2008/TT-BYT on drug labeling (referred to as the
Circular No. 04/2008/TT-BYT). In order to implement the Circular in unison with
Vietnam's commitments during its integration into ASEAN and the world, the
Ministry of Health provides the following guideline for the implementation of
certain details of the Circular in conformity to the approval by the heads of
the Ministry of Health and the Drug administration of Vietnam - Ministry of
Health:
1. Origin of drug as defined
in Point O, Clause 3, Part I:
Origin is “… country or territory where the entire
production of the drug or the final stage of basic processing occurs ..."
with three options according to ASEAN's common technical dossier that Vietnam
has harmonized with, as follows:
- The country where the final
dosage form is produced and/or
- The country where batches of
the drug are produced or
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2. Word color, symbols and
images on drug label as per Section 7 of Part I:
“… the color of words and numerical
characters indicating mandatory details must contrast with the background color
of the label" includes embossing of numerical characters that specify
batch number, production date and expiry date for easy comprehension of
information shown on packaging.
3. Display of measuring units
as per Point b, Section 2, Part III from an original label (including secondary
and primary packaging):
- International measuring
units commonly used in the medical sector, such as IU or UI, and globally
regulated symbols of strength for special active ingredients can be displayed
in original writing without being translated into Vietnamese if such
translations may cause misunderstanding.
- For an amount lower than 1
mg or volume less than 1 ml, a period (.) or comma (,) can be used as a decimal
mark since the zero before the fractional part cannot lead to misunderstanding.
4. Display of production date
and expiry date as per Point dd, Section 5, Part III:
- If an original label in
foreign language indicates the production date and expiry date in month/year,
the date of expiry on the auxiliary label must adhere to the Circular and take
the first of the expiry month.
For example:
- Production date on the
original label is Jan/2008 or 01/2008, shelf life is 24 months
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- The separator for day,
month, year can be a slash (/) or a period (.).
- If primary packaging does
not indicate words “số lô SX” (production batch number) and “HD” (expiration)
and only displays numbers, the secondary packaging must show information in
full format according to regulations.
5. Position of name and
address of the distributor as per Point b, Section 7, Part III:
"... name and address of the distributor must
be at the same position with the name and address of the producer ..."
means being displayed on the same side of the packing, on which the name and
address of the producer are shown.
6. Display of the producer’s
name and address as per Point a, Section 7 and the origin of the drug as per
Point a, Section 8, Part III:
- If the country of production
is also the country of origin, the format “Sản xuất bởi: tên nhà sản xuất - tên
nước sản xuất" (Produced by: name of the producer - country of production)
or “Nhà sản xuất: tên nhà sản xuất - tên nước sản xuất" (Producer: name of
the producer - country of production in Vietnamese language) abides by Point a,
Section 7, Part III and Point c, Section 8, Part III.
For example:
- Sản xuất bởi: AstraZeneca AB
- Sweden (Produced by: AstraZeneca AB - Sweden) or
- Nhà sản xuất: AstraZeneca
AB; Sản xuất: Thụy Điển (Producer: AstraZeneca AB; Made in: Sweden).
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For example:
- Nhà sản xuất: AstraZeneca AB
- Sweden (Producer: AstraZeneca AB - Sweden)
Xuất xứ: Anh (Origin: England)
7. Name and address of the
organization and individual held liable for a drug imported as per Section 9,
Part III refer to the name and address of the producer.
8. Display of reminders as per
Section 6, Part III:
- The phrase “Thuốc bán theo
đơn” (Prescription drug) can be alternatively shown as "Thuốc kê đơn” or
“Thuốc này chỉ dùng theo đơn của bác sỹ” (Use drug only under prescription).
9. Display of reminders and
warnings on a direction for use insert as per Point b, Section 9, Part III:
- The symbol Rx on a drug
label indicates prescription drugs. Therefore, the phrase "Thuốc bán theo
đơn” (Prescription drug) or “Thuốc này chỉ dùng theo đơn của Bác sĩ” (Use drug
only under prescription) must be shown on a package leaflet that displays
information in Vietnamese and the symbol Rx shall be removed.
10. Definition of drugs put on
the market prior to the effect of the Circular No. 04/2008/TT-BYT as per Section
2, Part IV:
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11. Other details:
a. Circular No. 04/2008/TT-BYT dated May 12, 2008
came into force 90 days after its publishing on the official gazette; however,
the Government's Decree No. 89/2006/ND-CP dated August 30, 2006 had taken
effect in September 2007; therefore, organizations concerned can implement the
Circular prior to the date that it comes into force.
b. Labels and inserts granted registration number
prior to the date of effect of the Circular No. 04/2008/TT-BYT but containing
information not pertinent to the Circular:
- Organizations concerned
shall make revisions and be held responsible for maintaining labels and inserts
in compliance with the Circular. Approval by the Drug Administration of Vietnam
is not mandatory.
- If organizations request the
Drug Administration of Vietnam to review and approve new labels in conformity
to the Circular, their applications for label revision must abide by the
regulation on drug registration. The procedure for consideration and response
is subject to regulations on revisions to drugs granted registration number.
c. For drugs for which applications were submitted
to the Drug Administration of Vietnam prior to the date of effect of the
Circular No. 04/2008/TT-BYT:
- Drug Administration of
Vietnam shall consider applications and grant label registration number
according to guidelines on drug labeling in the Circular No. 14/2001/TT-BYT
dated June 26, 2001 or Circular No. 14/2000/TT-BYT dated June 22, 2000. When
the Circular No. 04/2008/TT-BYT comes into force, organizations must abide by
the Circular for putting their drugs on the market.
- Organizations can supplement
labels according to the Circular No. 04/2008/TT-BYT to be eligible for issuance
of registration numbers according to the Circular.
d. Replacement of package inserts with patient
information leaflets for OTC drugs:
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dd. Display of “Đặc tính dược động học, dược lực
học” (“Pharmacokinetics and pharmacodynamics) on a package insert of an OTC
drug:
OTC drugs are sold for common ailments without prescription.
The information on their pharmacokinetics and pharmacodynamics has been
published broadly on domestic and international medical documents; therefore,
such information is not required on their package inserts. Before the Ministry
of Health issues a list of OTC drugs, current non-prescription drugs shall
adhere to this guideline.
12. Drug Administration of
Vietnam shall consider and respond to special cases not mentioned in this
official dispatch>
Drug Administration of Vietnam - Ministry of Health
inform relevant organizations of such details for compliance. Difficulties
shall be reported to the Drug Administration of Vietnam for joint solutions.
HEAD
Truong Quoc Cuong