Tighter Vietnam Pharmacy Practice Requirements: Overcoming Challenges, Seizing Opportunities

Recent shifts in Vietnam's regulatory landscape signal a deliberate move towards international standards in pharmacy practice, presenting both a complex challenge and a significant opportunity for any pharmaceutical business establishment. 

As of 2025, the government is tightening the management of pharmaceutical business, with Circular 31/2025/TT-BYT, guided by the Ministry of Health, emerging as the cornerstone of this reform affecting all practice certificates.

For domestic and foreign pharmacists, these changes to practicing pharmacy are transformative. At Viettonkin Consulting, we see this not as a barrier, but as a strategic maturation of the market. It is one that will reward a well-prepared pharmaceutical business establishment that has secured its certificate of eligibility and is ready to navigate Vietnam’s evolving healthcare industry and its rules on drug information.

Key Takeaways:

• Vietnam's new regulations, guided by the Law on Pharmacy, aim to standardize the pharmacy practice industry and improve how drug information is managed.
• Foreign professionals seeking pharmacy practice certificates now face updated requirements for degree verification, professional experience, and mandatory Vietnamese language proficiency.
• The reforms create a more predictable environment for pharmaceutical business, fostering trust and attracting qualified talent to handle professional pharmacy activities.
• A pharmaceutical business establishment now bears greater responsibility for its staff, and failure to comply can impact its certificate of eligibility for pharmacy business.
• Proactive compliance, including early preparation of legal documents and technical documents, is crucial for obtaining pharmacy practice certificates and minimizing risks.

Regulatory Drivers: The Ministry of Health and the Law on Pharmacy

Vietnam's move to tighten control over its pharmaceutical sector is a calculated step driven by the amended Law on Pharmacy. 

This initiative is supported by a regulatory trio: the amended Law on Pharmacy (amended by Law No. 44/2024/QH15, effective July 1, 2025), Decree 163/2025/ND-CP, and the pivotal Circular 31/2025/TT-BYT from the Ministry of Health (effective July 1, 2025). This framework, enforced by the Ministry of Health, aims to achieve several key goals for every pharmacy business:

• Enhance patient safety through accurate drug information.
• Increase transparency for every treatment establishment and pharmaceutical business.
• Align the domestic market, including the handling of medicinal materials and drug materials, with global standards.

The primary motivation is to elevate the quality of healthcare by preventing misconduct in pharmacy practice. According to a recent Chambers and Partners report (2024), recent regulatory developments signal a maturation of governance. 

This reduces ambiguity for investors, making the process to achieve eligibility for pharmaceutical business clearer and creating a secure environment. The competent authority now has a stronger mandate.

Core Updates: The Pharmaceutical Practice Certificate and Rules for Medicinal Materials

Circular 31/2025/TT-BYT introduces several critical updates affecting all pharmacy practice certificates. Here are the most important changes:

1. Licensing, Qualifications, and Your Certificate of Eligibility

• Stricter Criteria: Harsher requirements for granting pharmacy practice certificates, which are essential for practicing pharmacy. The pharmacy authority will scrutinize every application.
• Verified Credentials: Applicants for practice certificates must provide verified degrees and prove capability. The person responsible for a pharmacy establishment must ensure all technical documents are complete.

2. Requirements for Foreign Pharmacists, Including the Medical Examination

• Formalized Degree Recognition: A more rigorous verification process for foreign degrees, requiring notarized Vietnamese translations of all legal documents.
• Comprehensive Vetting: Foreign pharmacists must provide proof of experience, a clean legal record, and pass a medical examination. This applies to the persons responsible for clinical pharmacy activities.
• Clarified Practice Scope: The Circular now specifies the exact pharmacy practice categories open to foreigners, including roles in clinical trials and managing drug materials.

3. Language Requirements and Interpreter Rules

• Mandatory Language Proficiency: Foreign practitioners must demonstrate proficiency in Vietnamese or work with a registered interpreter when conducting drug information activities.
• Employer Accountability: The employing pharmaceutical business establishment is legally responsible for interpreter compliance, a key part of maintaining its certificate of eligibility for pharmacy business.

4. Reporting, Inspection, and Disciplinary Frameworks

• Tighter Reporting Deadlines: New deadlines for reporting changes related to pharmacists holding practice certificates. An amended and supplemented dossier may be required.
• Clear Grounds for Revocation: The Circular defines conditions for revoking a pharmacy practice certificate, including flawed drug information materials or non-compliance at treatment establishments.

New Opportunities: From Marketing Authorization to Clearer Pharmacy Business Rules

These stricter regulations create a landscape ripe with opportunity. The key benefits for the pharmaceutical business sector include:

• Improved Professional Standards: Higher trust in healthcare, better drug information, and alignment with international pharmacy practice expectations, including clinical pharmacy.
• Advantage for Qualified Professionals: A competitive edge for those holding a valid pharmacy practice certificate, especially in roles requiring management of traditional drugs or herbal drugs.
• Stronger Foundation for Investment: Reduced ambiguity for investors seeking eligibility for pharmacy business and clear rules for marketing authorization.

Challenges and Compliance Risks to Consider

Businesses and professionals must be aware of new compliance risks that could affect their certificate of eligibility:

• Complex Document Validation: Time-consuming processes for foreign degree recognition, impacting the timeline to get a pharmacy practice certificate applied for.
• Significant Language Barrier: Vietnamese proficiency requirements create operational hurdles, particularly for providing drug information or holding drug introduction seminars.
• Increased Employer Liability: A pharmaceutical business establishment faces penalties, especially if the person responsible for the quality control system fails to meet standards.
• Heightened Scrutiny: Stronger inspection from the competent authority on everything from drug storage to drug advertisement, impacting representative offices and facilities.

Strategic Recommendations for Success

To thrive, we recommend a proactive, four-step approach for any pharmacy business:

1. Develop a Proactive Compliance Plan: Align your strategy with the Law on Pharmacy and all relevant laws to ensure eligibility for pharmaceutical business.
2. Prepare Documentation Early: Initiate verification for your pharmacy practice certificate application, including all technical documents and notarized Vietnamese translations.
3. Formalize Contracts: Establish clear agreements with partners and interpreters, detailing responsibilities for professional pharmacy activities and quality assurance.
4. Engage Expert Advisors: Partner with a firm like Viettonkin Consulting to streamline the process of getting a pharmaceutical practice certificate and maintaining your certificate of eligibility.

The Path Forward: Following the Minister of Health's Vision

The updated Vietnam pharmacy practice requirements represent both a challenge and an opportunity. By elevating standards, the Minister of Health is cultivating a more transparent environment for every pharmaceutical business establishment.

Those who adapt quickly will benefit. With deep expertise in Vietnam's regulatory environment and the Law on Pharmacy, Viettonkin Consulting is uniquely positioned to help stakeholders turn these challenges into advantages.

Frequently Asked Questions

What is the biggest change for foreign pharmacists under Circular 31/2025/TT-BYT?

The most significant change is the formal language requirement, impacting how drug information is delivered. A foreign pharmacist seeking a pharmacy practice certificate must either be proficient in Vietnamese or use a registered interpreter, a rule the employing pharmacy establishment must enforce.

How long should a foreign pharmacist expect the licensing process to take in Vietnam now?

With more stringent verification for practice certificates, applicants should anticipate a longer timeline. Preparing for a 6 to 9 month process is realistic, assuming all legal documents, including proof of passing a medical examination, are in order from the start.

What is the most critical first step for a foreign-invested pharmacy to ensure compliance?

The most critical first step for a pharmaceutical business establishment is to conduct a gap analysis against the new pharmacy practice rules. This includes auditing the pharmacy practice certificates of all staff and ensuring the facility meets all good storage practice requirements.

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