Drugdu.com expert's response:

The qualifications required for foreign trade enterprises to act as agents for pharmaceutical exports primarily encompass the following aspects:

I. Basic Qualifications

1.Foreign Trade Management Right:
Foreign trade companies must possess general foreign trade import and export management rights, which serve as the fundamental prerequisite for acting as agents for pharmaceutical exports. This right permits the company to engage in or act as an agent for the import and export of various goods and technologies, except for those commodities and technologies whose import and export are restricted or prohibited by the state.

2.Registration:
Foreign trade companies need to register with relevant government departments. For instance, they must register with the Ministry of Foreign Trade and Economic Cooperation to obtain import and export qualifications and with the Entry-Exit Inspection and Quarantine Bureau to acquire a quarantine registration code. These registrations are crucial steps to ensure compliance with regulations pertaining to pharmaceutical exports.

Ⅱ. Pharmaceutical-Related Qualifications

1.Pharmaceutical Production/Trading License:
According to the "Law of the People's Republic of China on Pharmaceutical Administration," enterprises engaged in pharmaceutical business activities (including wholesale and retail) must obtain a Pharmaceutical Production/Trading License. Although foreign trade enterprises acting as agents for pharmaceutical exports do not directly produce drugs, they typically need to ensure that their partnering pharmaceutical manufacturing enterprises possess a valid Pharmaceutical Production/Trading License.

2.Export License:
For the export of pharmaceuticals, it is necessary to obtain an "Export License" from the National Medical Products Administration. This is a specific requirement for pharmaceutical exports, serving as proof of the exporter's legal qualification to export pharmaceuticals. Only enterprises holding an Export License are authorized to export pharmaceuticals to overseas markets.

III. Other Relevant Requirements

1.Requirements of the Importing Country:
In addition to the aforementioned domestic qualifications, foreign trade companies must also ensure that the companies accepted by the importing country possess corresponding Pharmaceutical Production/Trading Licenses and Import Licenses, and that the exported pharmaceuticals comply with the importing country's pharmaceutical quality standards. These requirements are common in international pharmaceutical trade, aimed at ensuring the safety and efficacy of pharmaceuticals.

2.Quality Control and Risk Management:
Pharmaceutical exporting companies must prioritize quality control, ensuring that pharmaceuticals meet relevant standards and requirements. Additionally, they should strengthen risk management, formulate contingency plans, and mitigate potential losses.

3.International Communication and Cooperation:
Active participation in international communication and cooperation is crucial for staying informed about international market dynamics and trends, thereby enhancing the competitiveness and adaptability of export operations.

In summary, the primary qualifications required for foreign trade enterprises to act as agents for pharmaceutical exports include foreign trade management rights, registration, Pharmaceutical Production/Trading Licenses (ensuring that partnering pharmaceutical manufacturing enterprises possess them), and Export Licenses. Compliance with the relevant requirements and standards of the importing country is also essential. The acquisition and adherence to these qualifications and requirements serve as vital safeguards for ensuring the legality, safety, and smooth operation of pharmaceutical export business.