Violations related to packaging, drug labels and drug ingredients will directly affect the quality, transparency and traceability of products.
In order to tighten drug management and ensure safety for users, the Government has issued Decree No. 90/2026/ND-CP stipulating penalties for administrative violations in the field of health.
Article 64 mentions violations of regulations on packaging, drug labels, and drug ingredients:
1. A fine of 5 million VND to 10 million VND shall be imposed for one of the following acts:
a) Importing, buying, and wholesaling drugs and drug ingredients that are no longer intact in the manufacturer's commercial packaging, unless permitted by law;
b) Importing medicinal herbs without stating the origin of the medicinal herbs on the outer packaging of the medicinal herbs.
2. A fine of 10 million VND to 20 million VND shall be imposed for one of the following acts:
a) Production and import establishments of drugs and drug ingredients with packaging not in accordance with the approved dossiers, except for cases specified in point b, clause 3 of this Article;
b) Registered establishments, pharmaceutical business establishments erase, correct, or change information about the date of manufacture, batch number of drug production, drug ingredients recorded on the original label;
c) Not updating drug information on labels and instructions for use of drugs circulating in Vietnam as required by the Ministry of Health;
d) Importing establishments, registration establishments, and domestic production establishments circulating drugs and drug ingredients with labels and user instructions that are not consistent with the approved content or do not accurately reflect the information of the drug for the content not required for approval.
e) Importing establishments, registration establishments, and domestic production establishments circulating drugs and drug ingredients with labels and user instructions that are not consistent with the approved content or do not accurately reflect the information of the drug for the content not required for approval.
3. A fine of 20 million VND to 30 million VND shall be imposed for one of the following acts:
a) Changing or correcting the expiration date of the drug stated on the label;
b) Packaging materials or packaging forms that do not meet the requirements for ensuring the quality of drugs and drug ingredients;
c) Not updating drug information related to contraindications, narrowing the target of use according to the provisions of law.
4. Additional penalties:
Suspending business activities related to violations for a period of 1 month to 3 months for the acts specified in point b, clause 2 and clause 3 of this Article.
5. Remedial measures:
Forcing the recall to remedy or destroy all drugs and drug ingredients that do not meet quality standards for the acts specified in points b, c, d, clause 2 and clause 3 of this Article.
