The general process of exporting medicines by international freight

The general process of exporting medicines by international freight

With the gradual control of the epidemic in China and the rapid spread of the epidemic outside China, China’s pharmaceutical exports are facing new opportunities. Starting from the general process of drug export, we will summarize the process of drug export in combination with the current Chinese laws and regulations on drug export. If you are a foreign importer of pharmaceuticals, want to import from China to your country, or export from China to other countries, I think you need to know this.


 Generally speaking, the procedural materials required for drug export are mainly prepared according to the requirements of the importing country. Drug administrations in different countries have different regulations and procedures, and importers or agents need to cooperate with the importing country’s registration declaration. Secondly, China has also made general regulations on matters related to the export of medicines, including general regulations for exporting enterprises and special regulations for export of medicines.


The general process of exporting medicines by international freight forward


1. Market development and cooperation


The export of medicines is mainly concerned with the requirements and regulations of the importing country. For example, when a drug is exported to the United States, it is necessary to issue DMF documents to the US FDA agency, such as drugs, packaging, excipients, colorants, etc. ; If the EU requires regular and strict GMP inspections on imported drug manufacturers, and unannounced unannounced inspections are not notified in advance, once violations are found, immediate measures should be taken. supporting documents.


2. Start and complete registration


According to the laws and regulations of the drug supervision and administration department of the importing country, if registration is required, it is necessary to complete the corresponding drug registration and submit the registration materials to obtain the preliminary access qualification of the drug importing country.


3. Production stocking


At this stage, international freight exporters sign orders or export purchase and sales contracts with importers, and make proper arrangements.


4. Export declaration


This stage mainly includes pre-export supervision and export declaration. The enterprise shall submit an application for pre-export inspection and supervision of a batch of products to the customs, and the customs shall issue the electronic basic account data as the customs declaration certificate after passing the comprehensive evaluation. Customs declaration exports are usually represented by customs declaration banks or freight forwarding companies, and declarations are made in accordance with customs requirements.


5. Freight transportation


In the process of international freight transportation, it is necessary to ensure compliance with China’s pharmaceutical GMP, GSP, “Pharmaceutical Freight Service Specifications” and the relevant regulations of the importing country for pharmaceutical freight transportation.


6. Customs clearance and delivery


Exporters provide a full set of customs clearance documents, including but not limited to commercial invoices, packing lists, bills of lading, certificates of origin, insurance policies, etc.

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