Drug import and export involves complex legal and regulatory requirements, and it is crucial for companies that want to export Chinese drugs to the Vietnamese market to understand the process of drug import and export between China and Vietnam. Today, we offer you a comprehensive understanding of the key steps of Chinese drug export and Vietnamese drug import in a common way to help you complete your trade transactions smoothly.

Export of Chinese medicines

Chinas law stipulates that in addition to narcotic drugs and certain psychiatric drugs, the export of drugs generally does not require special approval, but must meet a series of export procedures to ensure compliance.

Qualification of Import and Export Trade Subjects

First, according to the requirements of the Foreign Trade Law, enterprises should register with the competent department of foreign trade or its authorized agency under the State Council; secondly, according to the provisions of the National Customs Law (revision 2017), enterprises must complete registration in the customs. In addition, drug export enterprises should also hold the drug business license and drug production license to ensure that they have legal drug and business qualification.

Application for a Drug Export License

According to the Drug Administration Law of the Peoples Republic of China, the export of drugs must first apply to the National Food and Drug Administration or relevant regulatory authorities to apply for the Export License.The application must submit the production license, quality certification documents, detailed descriptions of ingredients and production process data, etc., to ensure that the exported drugs meet the quality and safety standards of the Chinese and international markets.

Export inspection inspection

Medicines must be inspected by customs and sanitation departments before export to ensure that they meet the health and quality standards of the target market. Generally, quality inspection reports and safety assessment documents of medicines are required to prove the safety and effectiveness of medicines.

Customs reporting

Exportors are required to submit relevant customs reporting documents to the customs, including export licenses, commercial invoices, packaging documents and proof of origin, etc. Due to the specialty of the medicines, stricter inspections are often required to ensure their quality and legality.

Import of Medicines in Vietnam

When medicines are exported to Vietnam, they must comply with relevant laws and regulatory requirements in Vietnam.

Registration of medicines

The Ministry of Health of Vietnam (MOH) requires all imported medicines to be registered with the Drug Administration (DAV). Registration of medicines must be submitted including medicinal ingredients, clinical trial data, manufacturing process, and evidence of the safety and effectiveness of medicines. Registration applications must also provide a certificate of access to other markets in order for Vietnamese regulators to evaluate the conformity of medicines.

Application for import license

After the drug registration is approved, the importer must apply for an import license to the Vietnam Drug Administration (DAV). The application must include a certificate of conformity of the medicinal product, its packaging and labels, as well as detailed arrangements for the storage and transport of the medicinal product to ensure that the medicinal product remains quality and safe during transport and storage.

3) Detection and testing

After imported drugs enter Vietnam, it is necessary to pass the sanitation and testing of the designated laboratory in Vietnam to confirm its quality and safety in accordance with national standards.Testing includes component analysis, impurities testing, stability testing, etc., generally takes several weeks to complete the full evaluation.

Customs and logistics

After completion of registration and quality inspection, the medicines can be subjected to customs procedures. Since the medicines are sensitive commodities, their customs procedures are more complex and require strict compliance with Vietnams customs policy, including providing proof of origin and inspection reports for all medicines.

Regulatory Requirements of Vietnam

1. labelling and packaging

All imported medicines must be labelled in Vietnamese with information such as effective ingredients, usage, date of manufacture and batch number.Importers must ensure that the labels comply with Vietnamese drug labelling regulations to help consumers correctly understand the medicinal information.

Drug Price Management

The sales price of imported drugs in Vietnam must be declared at DAV and must not exceed the price of similar drugs in other ASEAN countries.

Market access and distribution permits

Medicines must be approved by the Ministry of Health of Vietnam before entering the market. Distributors must be legally licensed and comply with the relevant regulations on the storage and distribution of medicines to ensure the quality of the medicines during the shipment process.

d) Special attention

Vietnam is a member of the Comprehensive and Progressive Trans-Pacific Partnership Agreement (CPTPP) and therefore has legal requirements regarding pharmaceutical patents and market access. Importers must ensure that products do not infringe patent rights and handle relevant patent issues before the drug is registered to ensure smooth entry into the Vietnamese market.