Active pharmaceutical ingredients (APIs) intended for export to the European Union need to obtain the Good Manufacturing Practice (GMP) certification and Written Confirmation (WC) document issued by the European Medicines Agency (EMA).

GMP certification for pharmaceuticals involves rigorous auditing of the manufacturer's quality management system, production processes, equipment, and personnel, ensuring the produced pharmaceuticals meet the quality and safety requirements of the EU. GMP certification is a prerequisite for obtaining the WC document; only businesses that have passed GMP certification can obtain the WC document and export APIs to the EU market.

The WC document is one of the required export documents for APIs to the EU, aiming to ensure that APIs exported to the EU meet the EU's quality and safety requirements. To apply for the WC document, the API manufacturing company needs to submit the following information to the EMA:

1.Name of the API and its CAS number

2.Name, address, and GMP certification number of the manufacturing company

3.Batch number and production date of the API

4.Quality standards and analysis methods of the API

5.Whether the API meets the EU's quality and safety requirements

After obtaining the WC document, the manufacturing company can export the API to the EU market. However, it should be noted that the validity period of the WC document is 6 months, after which a new application is required.

Please note that the specific application process and requirements for the WC document for APIs may vary depending on the type of product and the exporting country. Therefore, it is recommended to carefully understand the local requirements and procedures before applying, to ensure smooth processing of certification documents and successful export.