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ToggleVietnam’s Pharmaceuticals Law, also known as the Law on Pharmacy, is a comprehensive legal framework that regulates the production, distribution, use, and management of pharmaceutical products and activities in Vietnam. It was enacted by the National Assembly on April 6, 2016, and came into effect on January 1, 2017. The law aims to ensure the quality, safety, and efficacy of pharmaceutical products and to promote the development of Vietnam’s pharmaceutical industry.
This piece of legislation is an important part of doing business in Vietnam as a pharmaceutical firm and as such this article breaks down its key provisions.
Who does Vietnam’s Pharmaceuticals Law apply to?
Vietnam’s Pharmaceuticals Law applies to a wide range of entities and individuals involved in the pharmaceutical sector within the country. This includes:
Pharmaceutical Manufacturers and Distributors: All organisations and enterprises engaged in the manufacturing, importing, exporting, distributing, and wholesaling of pharmaceutical products must comply with the law. This includes local and foreign companies operating in Vietnam.
Retail Pharmacies and Pharmacists: Retail pharmacy owners and pharmacists must adhere to regulations regarding the storage, distribution, and sale of drugs, including compliance with Good Pharmacy Practices (GPP).
Healthcare Providers and Medical Institutions: Hospitals, clinics, and healthcare professionals involved in prescribing, dispensing, or using pharmaceutical products are subject to the regulations of the law, particularly in relation to the rational use of medicines and prescription controls.
Drug Researchers and Developers: Entities involved in pharmaceutical research, clinical trials, and the development of new drugs must follow specific guidelines for research conduct, drug approval, and registration procedures.
Drug Importers and Exporters: Companies that import or export pharmaceutical products must comply with regulations governing the licensing, registration, and quality control of drugs entering or leaving Vietnam.
Regulatory Authorities and Inspectors: The law also applies to regulatory bodies such as the Ministry of Health, which is responsible for enforcing the law, issuing licences, and overseeing compliance. Inspectors and authorities tasked with monitoring pharmaceutical activities must operate within the legal framework established by the law.
Consumers: While the primary focus is on organisations and professionals, certain provisions of the law, such as those related to drug safety, advertising, and rational use, are aimed at protecting consumers and ensuring they have access to safe, effective, and affordable medications.
In essence, the law applies to all stakeholders in the pharmaceutical supply chain, from production to end-use, ensuring that all activities related to drugs are conducted safely, ethically, and in compliance with regulatory standards.
Key provisions in Vietnam’s Pharmaceuticals Law
Vietnam’s Pharmaceuticals Law includes several key provisions outlined in specific articles, which regulate the pharmaceutical sector comprehensively:
1. Drug Registration and Licensing
Article 32: All pharmaceutical products, including both domestic and imported drugs, must be registered with the Ministry of Health before being marketed in Vietnam. The article details the necessary documentation and procedures for registration.
Article 33: Establishes the licensing requirements for drug manufacturing, importing, exporting, and retailing activities.
2. Quality Standards and Compliance
Article 6: Mandates adherence to Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), Good Pharmacy Practices (GPP), and Good Storage Practices (GSP) to ensure consistent quality throughout the supply chain.
Article 13: Requires all pharmaceutical entities to comply with the law and relevant quality standards in their operations.
3. Drug Price Management
Article 14: Regulates the pricing of pharmaceutical products to prevent excessive pricing and ensure public access to essential medicines. It includes mechanisms for price disclosure and control over certain categories of drugs.
Article 15: Sets out the responsibilities of the Ministry of Health in coordinating with other agencies to regulate and stabilise drug prices.
4. Rational Use of Medicines
Article 67: Regulates the prescription and sale of medicines to ensure their rational use. Prescription-only drugs must not be sold without a valid prescription.
Article 68: Prohibits misleading advertising and promotion of pharmaceutical products, ensuring that information provided to the public is accurate and not exaggerated.
5. Pharmacovigilance and Post-Market Surveillance
Article 62: Requires the establishment of a pharmacovigilance system to monitor the safety of drugs after they have been marketed. It mandates the reporting of adverse drug reactions and other safety issues.
Article 63: Outlines the responsibilities of manufacturers, healthcare providers, and pharmacists in reporting and handling drug safety issues.
6. Management of Controlled Substances
Article 68: Provides strict regulations on the management, storage, and use of narcotic drugs, psychotropic substances, and precursors. It includes licensing requirements and procedures to prevent misuse and illegal activities.
Article 69: Specifies the responsibilities of relevant authorities and healthcare facilities in controlling and managing these substances.
7. Research and Clinical Trials
Article 80: Regulates the conduct of clinical trials, requiring compliance with ethical standards and approval from relevant authorities. It protects the rights and safety of trial participants.
Article 81: Details the procedures for approving clinical trials and the requirements for reporting trial results.
8. Pharmaceutical Industry Development
Article 8: Encourages the development of the domestic pharmaceutical industry, promoting the production and use of generic drugs and supporting research and development activities.
Article 16: Provides incentives for investment in pharmaceutical manufacturing and technology transfer to strengthen local production capabilities.
9. Drug Import and Export Regulations
Article 47: Governs the import and export of pharmaceutical products, requiring strict compliance with licensing, quality standards, and safety regulations.
Article 48: Details the procedures and conditions for granting import and export licences for drugs and medicinal ingredients.
10. Education and Professional Standards
Article 75: Sets requirements for the education and training of pharmacists and other pharmaceutical professionals, ensuring that they meet high standards of professional practice.
Article 76: Mandates continuous professional development and certification for pharmacists to maintain their qualifications and competence.
These articles collectively form the backbone of Vietnam’s Pharmaceuticals Law, ensuring that pharmaceutical activities are regulated in a manner that protects public health, promotes rational drug use, and supports the sustainable development of the pharmaceutical industry.
How is Vietnam’s Pharmaceuticals Law enforced?
Vietnam’s Pharmaceuticals Law is enforced through a structured system involving various government agencies, regulations, and oversight mechanisms to ensure compliance with the law. The key aspects of enforcement include:
1. Regulatory Authorities
Ministry of Health (MOH): The primary authority responsible for implementing and enforcing the Pharmaceuticals Law. The MOH oversees drug registration, licensing, and quality control. It issues regulations, guidelines, and circulars to provide detailed instructions for compliance.
Drug Administration of Vietnam (DAV): A specialised department under the MOH, the DAV handles drug registration, import-export management, and monitoring of drug prices and quality.
Provincial Health Departments: These local authorities are responsible for monitoring and enforcing pharmaceutical regulations at the provincial level, including inspections of pharmacies, manufacturers, and healthcare facilities.
2. Licensing and Registration Controls
All pharmaceutical entities must obtain licences from the MOH for activities such as drug manufacturing, distribution, and retail. This includes compliance with Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and other quality standards.
Drug registration is mandatory for all pharmaceutical products before they can be marketed. The DAV reviews and approves applications, ensuring that drugs meet safety, efficacy, and quality standards.
3. Inspections and Audits
Regular Inspections: The MOH and Provincial Health Departments conduct regular inspections of pharmaceutical facilities, pharmacies, and healthcare institutions to ensure compliance with the law.
Unannounced Audits: These are conducted to check for compliance with drug quality standards, storage conditions, and proper handling of controlled substances. Violations can lead to fines, licence suspensions, or revocation.
4. Enforcement of Drug Quality Standards
The MOH enforces compliance with GMP, GDP, and other standards. Pharmaceutical entities are required to implement quality management systems and are subject to regular inspections and audits.
In cases of non-compliance, the MOH can impose administrative sanctions, recall products, or suspend licences.
5. Pharmacovigilance and Post-Market Surveillance
A national pharmacovigilance system is in place to monitor the safety and efficacy of drugs after they have been marketed. Manufacturers, healthcare providers, and pharmacists must report adverse drug reactions and other safety concerns to the DAV.
The MOH conducts post-market surveillance to identify and respond to safety issues, including the withdrawal or suspension of drugs from the market if necessary.
6. Penalties and Sanctions
Administrative Sanctions: These include fines, suspension, or revocation of licences for violations such as non-compliance with quality standards, unauthorised advertising, or failure to report adverse drug reactions.
Criminal Penalties: Severe violations, such as the production and distribution of counterfeit drugs, can lead to criminal prosecution, including imprisonment.
7. Public Reporting and Whistleblowing
The law encourages public reporting of illegal activities in the pharmaceutical sector, such as counterfeit drugs or illegal advertising. Whistleblowers can report to the MOH or local health departments, and their identity is protected by law.
8. Coordination with Other Agencies
The MOH collaborates with other government bodies, such as the Ministry of Public Security and customs authorities, to prevent and combat illegal activities, including the smuggling and counterfeit production of pharmaceutical products.
This multi-tiered enforcement mechanism, involving regulatory authorities, stringent licensing controls, regular inspections, and strict penalties, ensures that Vietnam’s Pharmaceuticals Law is effectively implemented and that public health is protected.
Summary
Vietnam’s Pharmaceuticals Law regulates the production, distribution, and use of pharmaceutical products to ensure their safety, efficacy, and quality. It establishes strict standards for drug registration, licensing, and compliance, and mandates oversight by the Ministry of Health to protect public health and promote the development of the domestic pharmaceutical industry.
While the law is comprehensive changes have been floated with a draft circular revising the law circulated earlier this year. With this in mind, foreign pharmaceutical firms doing business in Vietnam should make sure to keep up with the regulatory revisions process and the best way to do that is to subscribe to the-shiv.