Where are prohibited acts in pharmaceutical business regulated?

This English version is translated from the Vietnamese original. In case of any discrepancy, the Vietnamese version prevails.

Where are the prohibited acts in pharmaceutical business defined?

The legal basis is Article 6 – Prohibited Acts of the Pharmaceutical Law 2016 (No. 105/2016/QH13), as amended and supplemented by the Amended Pharmaceutical Law 2024 (No. 44/2024/QH15) effective from 01/7/2025 (hereinafter referred to as the "Pharmaceutical Law"). Enterprises, pharmacies, and distribution facilities must all comply with the amended and supplemented version.

Is operating a pharmaceutical business without a license prohibited?

Yes. This is the first and most fundamental prohibited act. According to Clause 1, Article 6 of the Pharmaceutical Law:

Operating a pharmaceutical business without a Certificate of Compliance with Pharmaceutical Business Conditions or during a period of suspension of operations or during a period of revocation of the Certificate of Compliance with Pharmaceutical Business Conditions.

This provision applies to all types of pharmaceutical business operations: manufacturing, importing, wholesale, retail, and related services. Business facilities must meet the requirements for material, technical, and human resources under Article 33 of the Pharmaceutical Law before being granted a license.

What types of medicines are prohibited from being traded?

Clause 5, Article 6 of the Pharmaceutical Law provides a comprehensive list of medicines and pharmaceutical ingredients prohibited from being traded:

• Counterfeit medicines and counterfeit pharmaceutical ingredients (point a);

• Medicines and pharmaceutical ingredients that fail to meet quality standards; have been subject to a recall notice from a competent state agency; have unclear origin or source; have expired (point b);

• Medicines and pharmaceutical ingredients on the list of prohibited imports or prohibited manufacturing (point c);

• Clinical trial medicines (point d);

• Medicines and pharmaceutical ingredients used as samples for registration, testing, scientific research, or participation in exhibitions and trade fairs (point đ);

• Medicines and pharmaceutical ingredients not yet authorized for circulation (point e);

• Medicines under national target programs, aid medicines, and other medicines subject to a prohibition on sale (point g);

• Retail sale of prescription medicines without a prescription; retail sale of vaccines (point h);

• Wholesale sale of prescription medicines at prices higher than the announced or re-announced intended wholesale price; wholesale and retail sale of medicines at prices higher than the listed price (point i).

Is selling medicines for an incorrect purpose or to an incorrect party a violation?

Yes. According to Clause 3, Article 6 of the Pharmaceutical Law:

Trading in medicines and pharmaceutical ingredients as defined in Clause 26, Article 2 of this Law and other medicines and pharmaceutical ingredients not for the correct purpose or supply not to the correct party as approved by the competent state management agency.

This is particularly important for distribution facilities of special pharmaceutical materials, narcotic substances, psychotropic substances, or precursors used as medicines—all transactions must be conducted with the correct party and for the correct purpose as approved by the competent authority.

How is the sale of prescription medicines without a prescription handled?

The act of retail sale of prescription medicines without a prescription is specifically listed in point h, Clause 5, Article 6 of the Pharmaceutical Law as a prohibited act. Additionally, retail sale of vaccines is completely prohibited. The specific administrative penalty for violation is determined by the specialized enforcement documents in the pharmaceutical field in accordance with the regulations of the competent authority.

Are there other prohibited acts related to pharmaceuticals besides business operations?

Article 6 of the Pharmaceutical Law is not limited to business operations. The prohibited acts also include: falsifying pharmaceutical registration documents, providing misleading information about medicines, illegal advertising of medicines, abusing position and authority to violate pharmaceutical regulations, and obstructing the inspection and audit activities of state agencies. Enterprises should read all of Article 6 to fully understand the scope of prohibitions, not just business-related acts.

What should pharmaceutical business enterprises pay attention to in order to avoid violations?

To comply with Article 6 of the Pharmaceutical Law, enterprises should take at least the following steps:

1. Ensure that the Certificate of Compliance with Pharmaceutical Business Conditions remains valid and is not in a period of suspension or revocation of rights;

2. Strictly control the origin, quality, expiration date, and circulation status of each batch of medicine before bringing it to market;

3. Only retail prescription medicines when there is a valid prescription; absolutely do not retail vaccines;

4. Post prices and sell at prices already declared to the competent authority;

5. Do not trade in clinical trial medicines, sample medicines for registration, aid medicines, or national target program medicines that are subject to a prohibition on sale.

A&D Law Firm provides specialized legal advisory services on pharmaceutical business conditions, pharmaceutical license document review, and administrative violation handling assistance in the pharmaceutical field. Enterprises in need of legal advice are welcome to contact our team of attorneys for timely support.

This article is for informational reference purposes only and does not substitute for official legal advice for specific cases. Laws and regulations may change; please contact A&D Law Firm's attorneys for advice tailored to your enterprise's actual situation.