With a dynamic pharmaceutical landscape, Vietnam presents significant opportunities for providers looking to introduce methadone pills and related products. Stringent regulatory frameworks ensure patient safety and drug efficacy, particularly for controlled substances like methadone.

As a leading supplier, Vonage Pharma offers a robust portfolio including Methadone HCl, Methadone Hydrochloride 5 mg, Methadone 20 mg, Methadone Oral Solution 25 mg/5 ml, and Methadone Hydrochloride 40 mg. Understanding the registration process and exact regulatory requirements for methadone pills in Vietnam is key to successful market entry and patient impact.

Regulatory Framework in Vietnam

Vietnam’s pharmaceutical sector has undergone rapid modernization, with regulations evolving to support a balance between access, safety, and international alignment. In May 2025, the Ministry of Health (MOH) issued Circular No. 12/2025/TT-BYT on registration of drugs and materials—with changes effective from July 1, 2025. This circular replaces previous guidance and places new demands on both local and foreign pharmaceutical suppliers seeking market authorization for methadone pills and related products (Vietnam New Regulations).

Classification and Prescription Status

Methadone pills are strictly regulated as controlled, prescription-only medicines in Vietnam, dispensed primarily within addiction treatment programs or as part of closely monitored pain management strategies. Changes to non-prescription drug lists in Circular 12/2025/TT-BYT do not affect methadone, which remains heavily scheduled due to its dependency and abuse potential.

Drug Registration Requirements

Drug registration is centralized under the Drug Administration of Vietnam (DAV), the authority responsible for reviewing dossiers and granting Marketing Authorization (MA). Here’s a breakdown of the key steps and documentation requirements for registering methadone pills:

1. Dossier Preparation

The registration dossier for methadone pills must be prepared in strict compliance with MOH and DAV guidelines. The core dossier includes (Pharmaceutical Registration in Vietnam):

• Application form
• Letter of authorization (if applicable)
• GMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice) certificates
• Certificate of Pharmaceutical Product (CPP), or Free Sale Certificate, consular legalized unless exempted by treaty 
• Detailed information on the drug substance and product (description, composition, stability, and bioequivalence data)
• Labeling materials and packaging information
• Translation into Vietnamese if documents are not already in the national language

CPP is a central requirement for imported methadone pills. It must follow the WHO format, bear appropriate signatures and seals, and be legally valid—typically considered valid for 24 months if not otherwise specified (CPP Requirements). For drugs already approved by authorities like the EMA or SRAs, Vietnam allows a registration dossier referencing international assessments, as long as the Vietnamese dossier is filed within five years of the foreign approval.

2. Application Submission

The prepared dossier is submitted to the DAV. Applicants must present all documents in Vietnamese or accompany them with certified translations. (Pharmaceutical Registration in Vietnam).

3. Review and Evaluation Timeline

Once submitted, the DAV organizes the dossier review and consults an Advisory Council. As of 2025, the authorities have introduced expedited review timelines—regulatory bodies can now process reference-based approvals in as little as nine months, and they have streamlined renewal documentation. The average historical timeline for a complete registration review remains around 12 months.

4. Validity and Renewal

Once granted, the MA for methadone pills is valid for 12 months, published in the online system. Timely submission of renewal documents, now simplified, ensures the continued use or market presence of the product and allows for license validity during the renewal review. (Pharmaceutical Registration in Vietnam).

5. Import and Market Entry Considerations

For drugs not yet fully registered, temporary import licenses are sometimes available for urgent government health programs, valid for one year. However, routine supply and broad market distribution require full registration. The Prime Minister’s Decision No. 68 and procurement regulations prioritize locally produced drugs for government tenders, so foreign companies must consider having a local manufacturing or packaging partner for competitive access (state.gov).

6. Other Regulatory Updates

The latest amendments also:

• Legalize online sales for non-prescription drugs (not applicable to methadone).
• The authorities require all price declarations to go public before market entry, fostering transparency.

Foreign-registered dossiers prior to July 1, 2025, can choose to follow either the old or new regulations for continuity, minimizing disruption while adapting to new requirements (vietnam-briefing).

Statistical Overview and Market Relevance

• Methadone maintenance therapy has been a pillar of Vietnam’s strategy against opioid dependence, with over 53,000 patients reported as of early 2024 (). The need for high-quality, consistent supply of methadone pills remains strong for public health.
• According to the Ministry of Health, the proportion of domestically produced pharmaceuticals has increased, but demand for international standards and innovative formulations like Methadone Oral Solution 25 mg/5 ml persists, especially in urban centers ().
• Estimated annual market growth for controlled substances in Vietnam’s pharmaceuticals sector remains between 10-15%, underlining the urgency for international suppliers to ensure regulatory compliance and timely registration.

Vonage Pharma: Leading the Way

Vonage Pharma brings an advanced product portfolio to providers in Vietnam, including:

• Methadone HCl
• Methadone Hydrochloride 5 mg
• Methadone 20 mg
• Methadone Oral Solution 25 mg/5 ml
• Methadone Hydrochloride 40 mg

Our team manufactures all products under strict GMP standards and ensures they meet global safety requirements. Our company supports providers throughout the complex registration process by supplying documentation, certificates, and technical support to satisfy Vietnamese regulatory requirements.

Conclusion

Registering methadone pills in Vietnam requires close attention to evolving regulations. It also demands accurate and timely dossier submission. In addition, providers must cooperate with both regulatory bodies and local partners. The new MOH circulars and streamlined approval processes are now in place. As a result, pharmaceutical providers have a clearer regulatory path for methadone pills. This helps improve patient safety and public health outcomes.

Vonage Pharma stands ready as a trusted partner. We offer complete, compliant product lines and regulatory expertise. Our support ensures safe and efficient market entry into Vietnam’s growing pharmaceuticals sector. For more information or assistance, contact our regulatory affairs team today.