Health product registration is a document-driven process. Delay is rarely caused by the product and far more often by files that are inconsistent or use terminology the assessor does not recognise.
Parts of the dossier that usually need translating
- Quality documents: material specifications, analytical methods and validation results
- Preclinical and clinical documents: protocols, study reports and their summaries
- Good manufacturing practice certificates from the country of origin
- Certificates of free sale from the origin country's authority
- Product information, leaflets and packaging labels
- Manufacturer and marketing authorisation holder legality documents
- Distributor appointment agreements and registration powers of attorney
Consistency between technical files and labelling
The active ingredient name, strength, dosage form and indication appear in many places: quality documents, summaries, leaflets and labels. Any discrepancy between them will be found by the assessor and will generate a question.
The effective practice is to build one product glossary before any file is translated, recording the official rendering of each ingredient name, strength unit and dosage form. That list then binds every file, including later updates.
Documents that usually require sworn translation
| Document type | Form usually required |
|---|---|
| Certificates from the origin country authority | Sworn translation, often with legalisation |
| Manufacturer legality documents | Sworn translation |
| Appointment letters and powers of attorney | Sworn translation |
| Clinical study reports | Professional translation, unless otherwise required |
| Quality documents and analytical methods | Professional translation |
| Labelling and product information | Professional translation with a guidance compliance check |
| The required form varies by product type and registration pathway. Confirm with your registration consultant before fixing the scope of the quotation. | |
Managing dossier updates
A registration dossier does not end when the licence issues. Formulation changes, manufacturer changes, renewals and product information updates create a stream of documents that continues for years.
For that reason, a vendor's ability to maintain a glossary over time is worth more than a rate difference. Update files that use different terminology from the original filing generate questions that should never have existed.
Start earlier than feels necessary
Certificates from the origin country authority often need legalisation or an Apostille before they can be translated and used. That chain runs across borders and cannot be shortened by paying more. Start with these documents, not with the easiest ones.
Map the certification chain