What Is The Export Procedure For API?

The export drugs shall be examined by the Institute for drug control of all provinces, autonomous regions and municipalities directly under the central government, and shall be exported by the local health department after examination and approval.

Basic principles of export Drug Administration

1, the units that produce pharmaceutical products must have a license for pharmaceutical production enterprises.

2, the export of drugs should be put forward by the foreign consignee. The domestic pharmaceutical companies will sign the contract according to the actual production potential.

3, the effect of uncertainty and other reasons, domestic production or sale and use of drugs have not been stopped, in principle, do not export.

If the foreign demand is made, the foreign trade department may declare to the local health department with a copy of the contract. After approval, the export department will be allowed to export.

4, the pharmaceutical standards of the two sides can be made according to the requirements of the Chinese Pharmacopoeia, and in principle, they should be exported according to the recent Pharmacopoeia.

Quality standard for exported drugs

Generally speaking, the foreign trade department is based on the quality standard stipulated in the supply contract signed with foreign countries.

1, where all the pharmaceutical products that meet the domestic three grade standard production are completely identical with those of the domestic market, the production plant shall report to the local health department and send it to the local drug inspection institute for technical examination. If the name, specifications and prescriptions of the drugs are different from those of the domestic products, they conform to the three level of the domestic standards. They must put forward the reason or basis for changing the name, specifications and prescriptions, and report to the local health department and send them to the local drug inspection office (with samples) for examination.

2, where the export products are produced by imitation of foreign products or produced according to the prescriptions provided by foreign businessmen, the factory shall give reasons for it and submit the relevant reference materials to the local health office and send it to the local drug inspection office (with samples).

3, the export products approved by the health department have agreed to be reissued to the health department for approval and sent to the drug inspection office (with export samples) for technical review.

No export is permitted without the approval of the Department of health.

4. Any central and Western packaging, packaging, processing and processing of Chinese and Western medicines, a letter from the pharmaceutical factory and a copy of the contract for external pactions to the local health office for the record, and sent to the local drug inspection institute.

5. Any export drug that has not been approved for production in China shall be handled according to the new drug approval method promulgated by the Ministry of public health.

6, the export of narcotic drugs and psychotropic substances shall be submitted to the Ministry of health for application, and the import licenses issued by the competent government departments of the importing countries shall be submitted for examination and approval. After approval by the Ministry of health, the export licenses for narcotic drugs and the export licenses for psychotropic substances can be issued for export procedures.

On the issue of exporting drugs to domestic market

All medicines for export, which are not approved by the health administrative department for sale, are sold in the domestic market. If a pharmaceutical factory needs to sell its products domestically, it must declare to the local health department, and it will be sold in the market if approved.

Inspection of exported drugs

1, declare.

2, registration number.

3, technical review.

4, submit the examination and approval.

5. Issue proof.

Inspection charges for import and export drugs

The inspection fees for import and export drugs shall be collected by inspection fees, sampling fees and certificate fees according to the standards stipulated by the Ministry of health.