PHARMACEUTICAL IMPORT PROCESS AT SMARTLINK

Pharmaceutical importation is a highly regulated sector in Vietnam. Due to its direct impact on public health, businesses looking to import pharmaceuticals must strictly adhere to legal requirements, quality standards, documentation regulations, and applicable tax rates. This article provides a comprehensive and detailed overview of the pharmaceutical import process, enabling businesses to proactively comply with procedures while saving time and costs.

 

1. Conditions for Importing Pharmaceuticals

To legally import pharmaceuticals into Vietnam, businesses must meet the following legal and technical conditions:

• Possess a Certificate of Eligibility for Pharmaceutical Business issued by the Ministry of Health.

• Comply with GSP (Good Storage Practices) standards.

• Hold a valid pharmaceutical import license issued by the Administration of Traditional Medicine and Pharmacy.

These conditions ensure that businesses have the necessary legal and technical capacity to engage in the import and distribution of pharmaceuticals.

 

2. Required Documentation for Pharmaceutical Imports

To complete the import process, the following documents must be prepared:

• Business registration certificate (with pharmaceutical trading listed as a business line).

• Import license issued by the Ministry of Health.

• Commercial Invoice.

• Packing List.

• Certificate of Origin (C/O) — required for preferential tax treatment.

• Quality control/test certificates for each batch (if subject to testing requirements).

• Commercial contract and product catalogue (if applicable).

 

3. Detailed Pharmaceutical Import Process

To ensure compliance with regulations, the import process should follow these steps:

Step 1: Apply for an Import License

Submit an application to the Ministry of Health, including business registration, purchase contract, technical documentation, and product catalogue.

Processing time: approximately 10–20 working days.

 

Step 2: Product Quality Inspection

Imported pharmaceuticals must undergo quality testing by a designated agency (Administration of Pharmaceutical Management).

Samples and translated test certificates (if required) must be submitted.

 

Step 3: Customs Declaration

Declare goods electronically via the VNACCS system.

Attach all required documents: Invoice, Packing List, C/O, import license, etc.

 

Step 4: Customs Clearance

Upon meeting quality control requirements, submit the inspection certificate to proceed with customs clearance.

Goods are then delivered to the warehouse and ready for distribution.

4. Import Taxes on Pharmaceuticals

Common import tax rates:

• Standard import duty: 5% to 12% (depending on the type of pharmaceutical).

• Preferential rates: 0% with a valid C/O under FTAs with the EU, South Korea, Japan, ASEAN, etc.

 

Value-Added Tax (VAT):

• The applicable VAT rate for pharmaceuticals in Vietnam is 5%, considerably lower than that for other goods, to support the healthcare sector.

 

Conditions for Preferential Tax Rates:

• Proper presentation of the C/O form (e.g., EUR.1 for EU-origin goods).

• Accurate HS Code classification for each product.

 

5. Key Considerations When Importing Pharmaceuticals

To ensure a smooth import process, businesses should pay close attention to the following:

• Choose the correct HS Code to accurately determine the type of drug and its applicable tax rate.

• Label products in compliance with regulations: Vietnamese labeling is mandatory, including full information on ingredients, concentrations, manufacturer, etc.

• Comply with quality inspection: products must not be distributed if they fail quality testing.

• Stay updated on legal and tax policy changes, which may be revised annually.

• Use specialized logistics services: certain pharmaceuticals require cold storage or temperature-controlled transportation — choose a provider experienced in pharmaceutical logistics.

 

6. Conclusion

Pharmaceutical importation involves complex procedures and strict compliance with legal, technical, and documentation requirements. Preparing complete dossiers, understanding customs and quality inspection processes, and staying informed about tax policies will help businesses minimize legal risks and optimize costs.