CPP Requirements for Imported Drug Registration in Vietnam

The Certificate of Pharmaceutical Product (CPP) is one of the most important documents required when registering imported drugs in Vietnam. In Vietnam, CPP requirements are governed by Circular 08/2022/TT-BYT, issued by the Ministry of Health. This guide outlines the current requirements, verification procedures, and product-specific scenarios related to CPPs. For a full overview of imported drug registration, see our guide to imported drug registration in Vietnam.

1. Requirements for a Valid CPP

To be accepted by the Drug Administration of Vietnam (DAV), a CPP must:

Follow the WHO-recommended format (available at who.int).
Include the name and signature of the signatory, the issuing date, and the official seal.
If no seal is present, provide justification that the seal is not required under the laws of the issuing country.

2. Validity Period of the CPP

The CPP must be valid at the time the dossier is submitted.
If no validity period is stated, the CPP will be considered valid for 24 months from the date of issuance.

3. Consular Legalization

The CPP must be consular legalized, unless exempted under international treaties or bilateral agreements to which Vietnam is a signatory.

4. When CPP Verification Is Required

The Drug Administration of Vietnam may verify the authenticity of the CPP in the following situations:

Signs of tampering, correction, or erasure;
The applicant has previously been penalized for submitting false information;
The manufacturer is applying for registration in Vietnam for the first time;
The CPP is electronic and cannot be verified via the link provided;
The CPP lacks an official seal;
The Advisory Council requests verification.

🔍 How Verification Is Conducted:

DAV will coordinate with relevant competent authorities including:

The Consular Department – Ministry of Foreign Affairs or Vietnamese embassies abroad (for legalization);
The issuing foreign authority or regulatory body (for document content).

5. CPP Requirements by Product Category

a. Generic Drugs, Probiotics, Herbal Medicines

- Submit 1 CPP confirming the product is approved and marketed in the country of manufacture.
- If the CPP confirms that the drug is not authorized in the country of manufacture, or is authorized but not actually marketed there, an additional document must be submitted from the European Medicines Agency (EMA) or a Stringent Regulatory Authority (SRA) confirming that the product is approved and actually marketed in that country. The document must include at least the following information: product name, active ingredient(s), strength or concentration, dosage form, and the name and address of the manufacturer.

b. New Chemical Entities (NCEs), Vaccines, Biologics (excluding probiotics)

If the competent authority in the country of manufacturer is under EMA or SRA : only 1 CPP is required to confirm the product is approved and marketed in the country of manufacture.
In all other cases, submit:
- 1 CPP issued by the competent authority in the country of manufacture, and
- 1 CPP issued by EMA or SRA confirming the product’s approval and actual marketing, including at least the following information: product name, active ingredient(s), strength or concentration, dosage form, and the name and address of the manufacturer.

6. Special Exemptions

If the CPP is non-compliant, the Minister of Health may decide based on the Advisory Council’s advice, provided the product is authorized by at least one competent authority and meets one of the following conditions:

Drugs needed for defense, disaster relief, or epidemic control;
Vaccines in the National Expanded Immunization Program (EPI) with no substitute;
Products covered under mutual recognition agreements between Vietnam and other countries.

This article helps pharmaceutical applicants and foreign manufacturers understand the strict yet transparent documentation requirements when entering the Vietnamese market. Accurate preparation of CPP documents—especially for verification and legal compliance—will reduce delays in the registration process.