Công văn số 7043/QLD-TT về việc hướng dẫn thực hiện Thông tư số 04/2008/TT-BYT ngày 12/5/2008 hướng dẫn ghi nhãn thuốc do Cục Quản lý dược ban hành

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

- The country from which products are transported to the importing country.

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

- Date of expiry on the auxiliary label is 01/01/2010

- 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).

- If the country of production is not the country of origin, the format must be “Nhà sản xuất: tên nhà sản xuất - tên nước sản xuất” and “Xuất xứ: tên nước xuất xứ bằng tiếng Việt” (Producer: name of the producer - country of production” and Origin: country of origin in Vietnamese language).

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:

A drug labeled according to the Circular No. 14/2001/TT-BYT dated June 26, 2001 or Circular No. 14/2000/TT-BYT dated June 22, 2000 shall only be considered to be put on the market and exempt from label supplementation and permitted for free sale until its expiry date after it has undergone quality inspection as per current regulations after its production, importation and storage and before its delivery in the mandatory presence of invoice(s) from the producer, importer or import authorizer to the effective date of the Circular No. 04/2008/TT-BYT.

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:

Pursuant to ASEAN’s common technical dossier (ACTD), a patient information leaflet indicates information of an OTC drug, is part of an application for drug registration and is not deemed as a package insert (which is part of a drug label attached to commercial packaging).  Therefore, every drug must be enclosed with a package insert according to the Circular No. 04/2008/TT-BYT and this official dispatch.

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.

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