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Vietnam is fundamentally restructuring its pharmaceutical law, a critical shift headlined by the new Circular 31/2025/TT-BYT. For any pharmaceutical business, understanding the specific new regulations on the methods, forms, and introducers of drug information is central to operational success and securing marketing authorization. As a critical YMYL sector, the pharmaceutical sector demands the highest standards, a principle that underpins this amended pharmaceutical law.
At Viettonkin Consulting, our expertise is frequently applied to navigating Vietnam's complex legal documents, particularly for a pharmaceutical business establishment. This guide breaks down the new regulations from the Ministry of Health (MOH), providing insights for any pharmaceutical business aiming for sustainable growth.
Key Takeaways:
- Regulatory Overhaul: Vietnam's legal framework for drug information is transitioning to a digital model, driven by the amended pharmaceutical law (Law No. 44/2024/QH15).
- Clear Distinction: The new regulations draw a firm line between drug information (for professionals) and advertising, affecting every pharmaceutical business.
- Licensed Introducers: The role of a drug introducer is now formalized and requires a pharmacy practice certificate, transforming them into regulated communicators for the pharmaceutical business establishment.
- Pre-Approval is Mandatory: All drug information materials must be pre-approved by the MOH before use, a key step after receiving marketing authorization.
- Compliance as an Advantage: Mastering these new regulations is a strategic advantage for any pharmaceutical business looking to build trust and achieve long-term success with their marketing authorization.
The Amended Pharmaceutical Law: New Vietnam Regulations on Drug
The most significant transformation in Vietnam's system is its shift to a digital compliance model, designed to simplify administrative procedures for the pharmaceutical business.
The foundation of this legal framework is the amended Law on Pharmacy, documented as Law 44/2024/QH15, which provides principles for all pharmacy activities. Supporting this law are detailed regulations, including the pivotal Circular 31/2025/TT-BYT, which specifies rules for providing drug information. Obtaining marketing authorization is a central theme.
These instruments apply to every pharmaceutical business establishment, drug introducers, and distributors. The competent authority overseeing enforcement is the MOH and its Drug Administration of Vietnam (DAV). This guide provides practical applications for any pharmaceutical business beyond just listing legal documents.
Regulations on Methods, Forms, and Raw Materials
A core principle of the new pharmaceutical law is that "informing is not advertising." The regulations create a clear distinction for how a pharmaceutical business can discuss its products that have marketing authorization.
Approved methods for delivering drug information include meetings with professionals who hold pharmacy practice certificates, seminars, and digital content. Permitted forms include leaflets and e-brochures, which must align with approved package inserts. As Vietnam embraces digital transformation, the Ministry of Health will issue further guidance. All drug information must be faithful to the approved marketing authorization; promoting off-label uses is strictly prohibited. The focus is always on ensuring drug quality, starting from raw materials and medicinal materials.
Responsibilities and Licensing of Pharmaceutical Drug Introducers
The era of loosely defined sales roles is over. Under the new regulations, a "Licensed Introducer" is a regulated communicator, and the person responsible at the pharmaceutical business establishment must ensure compliance.
To qualify, an individual must have the proper training and a valid pharmacy practice certificate. The Circular 31/2025/TT-BYT mandates a rigorous licensing process for anyone practicing pharmacy in this role. Companies must implement MOH-approved training programs. These introducers are subject to strict supervision. Any violation can lead to severe penalties, including suspension of their pharmacy practice certificates and a ban on the company's pharmaceutical activities.
For instance, a European pharmaceutical business establishment we advised had to overhaul its training program to align with these requirements for pharmacy practice certificates, ensuring every introducer was certified before discussing products with marketing authorization.
Checklist: Securing Marketing Authorization and Managing Administrative Procedures
To assist any pharmaceutical business, we have developed this checklist.
- Secure Marketing Authorization: No drug information can be disseminated until the product has a valid marketing authorization from the Ministry of Health. This applies to both new drugs and generic drugs. The process requires extensive documentation, including clinical trial data for a new drug.
- Pre-Approval of Materials: Every piece of informational material must be approved. The content must match the package inserts tied to the marketing authorization.
- Quality of Drug Materials: A pharmaceutical business establishment is responsible for verifying the raw materials, drug materials, and medicinal materials used in its products. The quality of pharmaceutical ingredients is key to maintaining marketing authorization.
- Prohibited Practices: There is zero tolerance for advertising prescription drugs or offering material benefits to professionals. This includes psychotropic drugs and other certain drugs under special control.
| Compliance Area | Pharmaceutical Enterprise Responsibility | Licensed Drug Introducer Responsibility |
| Content | Get pre-approval for materials based on the marketing authorization. | Only use approved drug information and package inserts. |
| Licensing | Manage training and ensure all introducers hold valid pharmacy practice certificates. | Maintain their pharmacy practice certificate and adhere to rules for pharmacy practice. |
| Activity | Supervise all professional pharmacy activities. | Report activities accurately. |
| Ethics | Ensure the pharmaceutical business avoids prohibited practices. | Refrain from offering incentives. |
Strategic Outlook: Technology Transfer and Customs Clearance
While these regulations add complexity, they also create opportunities. A pharmaceutical business that masters digital compliance will gain an advantage. For investors, the new regulations also emphasize technology transfer and opportunities for importing drugs with a clear path to marketing authorization, which involves simplifying customs clearance.
At Viettonkin Consulting, our team helps FDI enterprises navigate these challenges, from the initial application for marketing authorization based on clinical trials to establishing compliant training programs. In Vietnam’s evolving market, compliance is the most powerful lever for a pharmaceutical business to achieve success.
Frequently Asked Questions
What is the biggest change under TT BYT 31/2025 for drug information?
The most significant change is the formalization of the drug introducer role, which now requires a pharmacy practice certificate and strict supervision by the pharmaceutical business establishment. This ensures all drug information provided is accurate and ethical.
How does marketing authorization impact providing drug information?
A product must be granted marketing authorization by the Ministry of Health before any drug information activities can begin. All materials, including package inserts, must strictly align with the terms of the approved marketing authorization.
Should a foreign pharmaceutical business hire its own introducers?
Hiring your own team provides greater control over compliance with the new regulations and ensures they hold valid pharmacy practice certificates. However, using a distributor's team can accelerate market access. We often advise a hybrid model or a rigorous audit of the distributor’s team to ensure they meet the stringent requirements of the pharmaceutical law.
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