How to Register Imported Medicines in Your Market: A Document Checklist

Registration is where many import projects stall — usually for missing documents, not missing products.

Before selecting a supplier, confirm they can provide the full set: Certificate of Analysis (COA) with HPLC/GC chromatograms for the exact batch; Drug Master File (DMF) open parts where applicable; product dossiers in CTD format; GMP certificates; free sale certificates; and legalization (embassy or apostille) support.

At Sinophare we keep these documents ready for every regular item, because registration timelines in most markets are driven by document completeness rather than testing. Ask our regulatory support desk for a document sample pack for your target market before you commit to a supplier.