Drugdu.com expert's response:

Export Requirements for Pharmaceutical Raw Materials by Trading Companies：

I. Basic Qualifications

Import and Export Rights: According to the relevant provisions of the "Regulations of the People's Republic of China on the Administration of Import and Export of Goods," foreign trade companies need to obtain import and export rights, which are the basic qualification for conducting international trade.

Pharmaceutical Business License: Foreign trade companies must possess a legal pharmaceutical business license to purchase and export from domestic pharmaceutical enterprises or drug trading enterprises. If the foreign trade company itself engages in the production of pharmaceutical raw materials, it also needs to hold a valid pharmaceutical production license.

Dangerous Goods Business License: Since pharmaceutical raw materials often fall into the category of dangerous goods, foreign trade companies need to hold a dangerous goods business license to comply with the "Regulations on the Administration of Safety of Dangerous Chemicals."

Pesticide Business License: If the pharmaceutical raw materials are pesticides, it is necessary to obtain a pesticide business license. According to relevant regulations, units engaged in the import and export of pesticides should obtain the corresponding pesticide business license.

II. Specific Export Qualifications

Export License: Foreign trade companies need to possess a drug export license issued by the National Medical Products Administration. Additionally, if the pharmaceutical raw materials are goods under state-run trade management, they can only be operated by authorized enterprises or operated by non-authorized enterprises in accordance with national regulations.

Export Quota License: For some pharmaceutical raw materials subject to export quota management, foreign trade companies need to apply for an export quota license from the competent department of foreign economic and trade under the State Council based on the quota certificate issued by the export quota administration department.

III. Quality and Safety Certifications

GMP Certificate: The GMP certificate certifies that the production facilities of foreign trade companies meet international quality standards and is one of the important qualifications for the export of pharmaceutical raw materials.

Quality Assurance Agreement: This agreement clarifies the foreign trade company's commitment to the quality of pharmaceutical raw materials and is an important means to ensure the quality of exported pharmaceutical raw materials.

Certificate of Conformity: Foreign trade companies need to provide certificates of conformity for the drugs to prove their compliance with international standards.

IV. Other Qualifications and Requirements

Customs Declaration Form: Foreign trade companies need to provide customs declaration forms to certify the quantity, value, and name of the goods.

Foreign Exchange Registration: Foreign trade companies must follow the legal provisions on foreign trade, export customs declaration, and foreign exchange registration to complete the corresponding foreign exchange registration procedures.

Requirements of the Importing Country: Foreign trade companies also need to pay attention to the relevant regulations and requirements of the importing country for pharmaceutical raw materials to ensure that the products comply with the standards and regulations of the importing country. For example, if the importing country of pharmaceutical raw materials belongs to a regulated market (such as the European Union, the United States, Japan, etc.), it may be necessary to apply for relevant qualification licenses or registration with the drug regulatory department of the importing country.

In summary, to export pharmaceutical raw materials, trading companies need to possess qualifications such as import and export rights, pharmaceutical business licenses (or pharmaceutical production licenses), dangerous goods business licenses (if applicable), pesticide business licenses (if applicable), export licenses, and export quota licenses (if subject to quota management). They must also comply with relevant national and importing country regulations and requirements. At the same time, they should focus on product quality and safety to ensure the legality and compliance of exported pharmaceutical raw materials.