General trading enterprises, with import and export rights, want to export drugs, what procedures ne

Not all enterprises with import and export rights can export drugs, and enterprises that can export drugs must have an export drug license.

It is necessary to go to the Food and Drug Administration for approval.

Legal analysis: 1. Registration procedures must be carried out in the destination country of going abroad, which is different in each country, some countries need to re-do clinical trials, and some countries even need to re-do basic tests such as pharmacology and toxicology. 2. There are also some countries that require that the enterprises that produce the drug must also pass the certification to be eligible for export, of course, the items that require certification are different, some require EU certification, some FDA certification, WHO certification, and PQ certification.

3. Rewrite the packaging and instructions of all drugs, use the language of the export destination country, and conform to the relevant requirements of the export destination country.

Legal basis: Drug Administration Law of the People's Republic of ChinaArticle 27 For the first import of drugs, the importing unit must provide the instructions, quality standards, inspection methods and other relevant information and samples of the drugs, as well as the supporting documents approved by the exporting country (region) for production, and the import contract can only be signed with the approval of the health administrative department.

The export of drugs requires the manufacturer or the export company holding the drug business license to apply for an export license from the State Food and Drug Administration. Exported drugs shall be subject to technical review by the drug inspection institutes of all provinces, autonomous regions and municipalities directly under the Central Government, and shall be reviewed and approved by the local health department before they are allowed to be exported.

Article 15 of the Foreign Affairs Law.

Based on the need to monitor the import and export situation, the competent department of foreign affairs may implement automatic import and export licensing for some goods that are freely imported and exported and publish its catalogue.

For import and export goods subject to automatic licensing, if the seller or consignor submits an application for automatic license before going through the customs declaration formalities, the competent department of foreign affairs or the agency entrusted by it shall grant permission; If the automatic licensing procedures are not completed, the customs will not release them violently.

Import and export of technology that belongs to free import and export shall be filed and registered with the competent department of foreign affairs or the agency entrusted by it.

Legal analysis: 1. Registration procedures must be carried out in the destination country of going abroad, which is different in each country, some countries need to re-do clinical trials, and some countries need to re-do basic tests such as pharmacology and toxicology. 2. There are also some countries that require that the enterprises that produce the drug must also pass the certification to be eligible for export, of course, the items that require certification are different, some require EU certification, some FDA certification, Danmin also has WHO certification, and PQ certification.

3. Rewrite the packaging and instructions of all drugs, use the language of the export destination country, and conform to the relevant requirements of the export destination country.

Legal basis: Drug Administration Law of the People's Republic of ChinaArticle 27 For the first import of drugs, the importing unit must provide the instructions, quality standards, test methods and other relevant information and samples of the drug, as well as the certification documents of the exporting country (region) for approved production, and the import contract can only be signed with the approval of the health administrative department.