|Cơ quan ban hành:||Bộ Y tế||Số công báo:||Đã biết|
|Số hiệu:||04/2008/TT-BYT||Ngày đăng công báo:||Đã biết|
|Loại văn bản:||Thông tư||Người ký:|
|Ngày ban hành:||12/05/2008||Ngày hết hiệu lực:||Đã biết|
|Áp dụng:||Đã biết||Tình trạng hiệu lực:||Đã biết|
|Lĩnh vực:||Y tế-Sức khỏe|
Thông tư 04/2008/TT-BYT của Bộ Y tế về việc hướng dẫn ghi nhãn thuốc
THE MINISTRY OF HEALTH
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:
1. Scope of regulation
a/ This Circular guides contents and methods of labeling medicines circulated in
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.
2. Subjects of application
This Circular applies to organizations and individuals that manufacture, trade in. import or export medicines in
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;
- Outer packages, which are used for packaging one or several medicine units contained in immediate packages.
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.
Use instruction insert means a document accompanying the commercial package of a medicine and bearing use instructions and other required contents.
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
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.
8. Languages used on medicine labels
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.
b/ Medicines manufactured in
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
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.
CONTENTS OF MEDICINE LABELS
Section A. LABELS OF ORDINARY MEDICINES
1. Mandatory contents of medicine labels
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:
i/ Use instructions.
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;
- Net weight or volume;
- 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:
- 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 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:
- The manufacture batch number and expiry date;
- 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.
b/ For medicines of health programs not for sale under regulations, their labels must bear the phrase "medicine of program not for sale."
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 (
- Names of proprietary medicines.
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
a/ Packaging specifications of medicines must be indicated in quantity, net weight and net volume of medicines enclosed in their commercial packages.
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
a/ Treatment indications appearing on labels must be appropriate to the effect of medicines.
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.
d/ Manufacture batch number: Write as follow:
- "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.
- 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.
For example: Keep in a dry place and at a temperature not exceeding 30C.
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:
- Remarkable words or signs must be printed conspicuously in bold letters so as to be easily noticed:
- 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
+ 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;
The name of the packaging establishment must be printed in the same place and of the same letter font size with that of the semi-finished product manufacturer.
- 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
a/ Origin of a medicine shall be written as follows: Write the phrase "san xuat tai" (made in) or "che tao tai" (manufactured in) or "xuat xu " (originating from) followed by the name of the country or territory where this medicine is manufactured.
b/ For a medicine made in
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.
- Preparation form;
- Packaging specification;
- 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.
- Pharmacodynamic and pharmacokinetic properties (for pharmaceuticals);
- 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.
10. Auxiliary labels of medicines
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.
- Origin of the medicine.
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.
INSPECTION, EXAMINATION, AND HANDLING OF VIOLATIONS
1. Inspection and examination
a/ The Drug Administration of
b/ Provincial/municipal Health Services shall inspect and examine the implementation of this Circular in their respective localities.
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.
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
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.
FOR THE HEALTH MINISTER