You are using an outdated browser and your browsing experience will not be optimal. Please update to the latest version of Microsoft Edge, Google Chrome or Mozilla Firefox. Install Microsoft Edge

February 23, 2018

New Regulations on Pharmaceutical Product Labeling in Vietnam

Subscribe to Updates
Informed Counsel

On January 18, 2018, the Ministry of Health (MoH) of Vietnam issued Circular No. 01/2018/TT-BYT (Circular 01) on the labeling of pharmaceuticals (referred to hereinafter as “drugs” for brevity). This circular will take effect from June 1, 2018, and will replace the current drug labeling regulations (Circular No. 06/2016/TT-BYT).

Circular 01 includes four chapters and 40 articles, providing guidelines on: (1) labels of finished product drugs and drug raw materials; (2) package inserts of finished drugs; and (3) changing the shelf life indicated on the label of finished drugs in special cases.

In light of the new circular, some notable changes will be forthcoming, including, among others:

Requirements for Package Inserts of Finished Drugs

Under current regulations, the package insert (PI) must include two separate sections, one with information for patients and the other with information for healthcare professionals. Under the new regulations, the PI will include only one section, containing general information for both patients and healthcare professionals. The simpler PI will reduce the time spent preparing the language for the PI and preparing packaging samples when registering drugs.

Package Insert Replacement after Finished Drug Is Imported into Vietnam

Under current regulations, a PI may not be replaced or supplemented after the finished drug is imported into Vietnam. Under the new Circular, this restriction is loosened, and a PI can be replaced or supplemented in Vietnam in the following circumstances:

  • When imported drugs with Marketing Authorization (MA) licenses have Vietnamese-language PIs in their packages but the PIs have not been updated per the MoH’s requirements; and
  • When imported drugs with import licenses do not have Vietnamese-language PIs in their packages.

Entities in Charge of Imported Drug Labeling

The responsible entities for drug labeling have been changed under the new circular, effectively releasing offshore manufacturers from labeling responsibility.

  • The responsible entities for a product with an MA license will be the importer and the MA holder. Currently, the responsible entities are the manufacturer and the MA holder.
  • The responsible entity for a product with an import license will be the importer only. Currently, the responsible entities are the manufacturer and the importer.

Transitional Provisions

Circular 01 provides the following transitional provisions:

  • Drugs granted registration numbers before June 1, 2018, may be sold with MoH-approved labels and PIs until the expiry date of the MA license.
  •  In the case of drugs for which the MA/import license dossiers were submitted to the DAV before June 1, 2018, and are awaiting the DAV’s approval, the following will apply:
  1. The applicant may submit updated labels and updated PIs for the drug in accordance with the new circular; or
  2. If no updated documents are submitted to the DAV, the applicant’s label and PI may be considered by the DAV under current regulations. However, within six months from the date on which an MA license is issued, the MA holder must submit updated labels and PI in the form of a variation registration to comply with Circular 01. Circular 01 is silent on the duty of the import license holder in this situation.
Download Full Article
Related Professionals

Industries

Life Sciences

Practices

Regulatory Affairs

Location

RELATED INSIGHTS​ 

June 4, 2026
Indonesia’s Minister of Health has issued Decree No. HK.01.07/MENKES/301/2026 on the Affixation of Nutritional Labels and Health Information to Ready-to-Eat Processed Food Products. The decree came into force on April 14, 2026, and was issued to implement the Health Law and Minister of Health Regulation No. 3 of 2026 on Disease Control. The decree requires the inclusion of Nutri-Level labeling on the front-of-pack nutrition labeling (FOPNL) to indicate the product’s nutritional level based on the content of sugar, salt, and fat (“gula, garam dan lemak (GGL)”). Changes from 2024 Draft Regulation The Nutri-Level labeling was previously proposed in 2024 by the Indonesian FDA (BPOM) through a draft regulation concerning nutrition information. While the categories of Nutri-Level labeling remain the same in the issued decree, the content requirements of sugar, salt and fat in the decree are different from the earlier proposal introduced in the 2024 draft BPOM regulation. In addition, the decree has further specified that the content of fat in the Nutri-Level labeling is the content of saturated fat, not total fat as previously proposed in the 2024 draft. The decree requires Nutri-Level labeling to be implemented in beverage products, which is the same as previously proposed in the 2024 draft BPOM regulation. Other food products may gradually become subject to mandatory Nutri-Level labeling under future implementing regulations. Nutri-Level Labeling Food levels as shown by the Nutri-Level labeling are classified into four color-coded categories from A to D: Level A (lowest amount) in dark green Level B in light green Level C in yellow Level D (highest amount) in red The Nutri-Level labeling is represented by the following image. The requirements for each level for sugar, salt, and fat content, based on amounts per 100 milliliters of product in beverage form, are as follows. Nutri-Level information must be
Read More
May 29, 2026
Indonesia’s Food and Drug Authority (BPOM) has issued Regulation No. 7 of 2026 on Drug Promotion and Advertising, establishing an updated framework for promotional activities involving medicinal products in Indonesia. The regulation took effect on April 16, 2026, and supersedes BPOM Regulation No. 2 of 2021 on Drug Advertising Supervision. The new regulation maintains general principles for advertising content, including requirements that advertisements be objective, complete, and not misleading, as further detailed in its annex. It also confirms that advertisements for nonprescription drugs directed to the public must obtain prior approval from BPOM before publication and must be in Bahasa Indonesia. The regulation provides a more comprehensive framework governing how drug promotion is conducted, introducing several notable additions and changes, as described below. Procedure and Requirements for Drug Advertisement Approval To apply for a drug advertisement approval, applicants must create an online account through the dedicated portal SIAPIK. Advertisement approval is available only for registered drugs; unregistered drugs are not eligible for advertisement approval with BPOM. The application must include the advertisement design, along with a translation if the design contains any wording in a foreign language. The submission format varies by media type, requiring, for example, copies in the form of print advertisements for visual media, scripts for audio media, and storyboards for audiovisual media. For online media—including social media—submissions should include any captions, descriptions, and hashtags that form an integral part of the advertising material. The approval timeline takes approximately 3–4 months, as BPOM will generally request additional information or revisions during the verification and evaluation process. Applicants have 20 days to submit any such requested documents. BPOM may also conduct a reevaluation of advertisements that have already received approval, based on monitoring results or new information regarding the safety and quality of the advertised drug. This
Read More
May 11, 2026
Vietnam’s legal framework governing chemicals has undergone significant reform, with the Law on Chemicals No. 69/2025/QH15 (Law on Chemicals 2025) taking effect on January 1, 2026. Together with a comprehensive set of implementing instruments issued in January 2026, including three decrees (No. 24/2026/ND‑CP, No. 25/2026/ND‑CP, and No. 26/2026/ND‑CP) and two circulars (No. 01/2026/TT‑BCT and No. 02/2026/TT‑BCT), the Law on Chemicals 2025 has significantly reshaped chemical registration and management requirements. Determining What Constitutes a “New Chemical” Among the most notable changes introduced under the Law on Chemicals 2025 are the rules governing the registration and management of new chemicals, which must be registered with the authority before being placed on the Vietnam market. Although the concept of new chemical registration was first introduced under the Law on Chemicals 2007, the corresponding registration mechanism has remained largely dormant in practice. Under the Law on Chemicals 2025, a “new chemical” is defined as a substance that is not yet included in Vietnam’s National Chemical Inventory and the list of foreign chemical inventories recognized by the competent Vietnamese authority (List of Foreign Chemicals). On a literal reading, the definition in the new law may suggest that a substance qualifies as a new chemical only if it is absent from both lists. Accordingly, a chemical present in either list should be treated as an existing chemical without the registration burden. However, a different interpretation emerges from Decree 26, which specifically requires registration of “new chemicals” even where such substances already appear in the List of Foreign Chemicals. This implies that inclusion in a recognized foreign inventory does not automatically exempt a substance from new chemical registration in Vietnam. This inconsistency between the statutory definition in the Law on Chemicals 2025 and the implementing provisions of Decree 26 creates significant interpretative and compliance challenges. At
Read More
April 29, 2026
Effective June 22, 2026, Thai Industrial Standards (TIS) for food contact paper and cooking paper will be enforced as mandatory for sale in the Thai market. This move has important implications for product licensing and tightens hygiene, labeling, and chemical-safety requirements for food-contact and cooking paper products. Thailand is strengthening its regulatory framework for paper-based culinary materials against a backdrop of accelerating global commitments to ESG and sustainability, as such materials—particularly those derived from natural or recycled fibers—have emerged as key alternatives to plastics in food preparation, cooking, and packaging applications. As a result, regulators worldwide are tightening controls to ensure that sustainability initiatives do not compromise consumer safety, particularly regarding the potential migration of chemical substances into food. Regulatory Framework: Voluntary vs. Mandatory Standards Standards under the TIS regime are generally classified into two categories. Voluntary standards allow manufacturers or importers to apply for a product license and affix the TIS mark to demonstrate product quality and build consumer confidence, but compliance is not legally required. Mandatory standards, by contrast, require manufacturers and importers to obtain a product license and affix the TIS mark before placing products on the Thai market, and noncompliant products cannot be legally sold. Previously, the TIS standards for food contact paper (TIS 2948-2562) and cooking paper (TIS 3438-2022) fell under the voluntary standard regime, meaning that obtaining a TIS license and displaying the TIS mark was optional. However, due to the increasing use of paper in food preparation and cooking, the Thai Industrial Standards Institute has determined that upgrading these standards to mandatory status is necessary to enhance consumer safety. As a result, all paper intended for food contact or cooking purposes must now obtain a TIS product license prior to sale in Thailand. Scope of the Standards The primary distinction between the
Read More