Drugdu.com expert's response:

Exporting pharmaceutical products to Vietnam requires a series of certifications to ensure compliance with Vietnamese regulations and legal sale in the Vietnamese market. Here are the primary certification requirements:

Ⅰ. Free Sales Certificate (FSC) from the Drug Regulatory Authority and Vietnam Embassy Authentication

Free Sales Certificate (FSC) from the Drug Regulatory Authority:

Definition: The Free Sales Certificate, also known as the Export Sales Certificate, is an official document issued by the drug regulatory authority, certifying that a particular pharmaceutical product or medical device meets relevant national standards and directives, allowing its free sale within the country and export to other countries.

Role: In international trade, the FSC is a crucial document for enhancing a product's international competitiveness, particularly when exporting to overseas markets like Vietnam, where it validates the legality and quality of the pharmaceutical products.

Vietnam Embassy Authentication:

Definition: Vietnam Embassy Authentication is an official certification process that verifies and confirms the authenticity and legality of the FSC.

Process: Typically involves preparing application materials (such as the original FSC, copies of the company's business license, product-related instructions, technical documents, etc.), submitting the application for review, paying fees, and receiving the authenticated certificate.

Importance: An FSC authenticated by the Vietnam Embassy carries more authority and is more likely to gain recognition and trust in the Vietnamese market.

Ⅱ. Other Potential Certifications Required

FORM E Certificate of Origin:

Definition: FORM E is a preferential certificate of origin for the ASEAN Free Trade Area, proving that the goods originate from an ASEAN country and are eligible for preferential tariff treatment within the ASEAN Free Trade Area.

Application: Pharmaceutical exports to Vietnam may require a FORM E certificate to enjoy tariff concessions. Enterprises can inquire about the agreed tariff rates through the China Free Trade Service Network and apply accordingly.

Commodity Inspection Certificate:

Definition: The Commodity Inspection Certificate, issued by China's Entry-Exit Inspection and Quarantine Bureau (CIQ), attests to the conformity of goods with relevant hygiene, safety, and quality standards.

Requirement: For certain commodities, especially food and cosmetics, Vietnamese customs may request a Commodity Inspection Certificate.

Import License:

Definition: Some commodities require an import license from the Vietnamese government before being imported into Vietnam.

Application: These commodities often include certain chemicals, pharmaceuticals, foods, machinery, and equipment. The application process for an import license can be complex, requiring detailed submissions and supporting documents.

Hygiene Certificate:

Definition: For food and beverage products, Vietnamese customs may demand a hygiene certificate issued by the Vietnamese health department or relevant agency, certifying that the goods comply with Vietnamese hygiene standards and requirements.

III. Considerations

Compliance: All certifications and documents must be accurate and comply with the requirements of Vietnamese customs and relevant authorities.

Timeliness: The processing time for certifications and documents may vary depending on specific circumstances, requiring enterprises to plan ahead and track progress.

Partners: Selecting experienced and reputable freight forwarders, customs brokers, and other partners can enhance clearance efficiency and success rates.

In conclusion, exporting pharmaceutical products to Vietnam necessitates the FSC and Vietnam Embassy Authentication, and potentially, other certifications such as the FORM E Certificate of Origin, Commodity Inspection Certificate, Import License, and Hygiene Certificate, depending on the circumstances. Enterprises must closely monitor Vietnamese import regulations and requirements to ensure seamless export and legal sale in the Vietnamese market.