It is required to submit proposed labels and package insert of the products to Vietnam MOH for their evaluation/approval. Labels for Vietnam market includes:
- Unit box (in English and Vietnamese)
- Blister/bottle/ampoule/vial/tube/sachet label (in English)
- Package leaflet (in Vietnamese)
Procedures to prepare label for registration purpose
Documents required to be submitted to Vietnam MOH:
– Proposed labels in Vietnam that are arranged according to local regulation, by revising artwork of the Product in original country.
– Package insert in Vietnamese, preparing by translated package insert of the Product in original country or package insert of referral brand name Product.
– Scanned copy label of the Products that are being marketed in original country
Manufacturer is requested to provide:
1/ Artwork of unit box, bottle/strip/blister/vial/ampoule in editable format (Adobe Illustrator or Corel). Our team will revise it according to local regulation, add some Vietnamese information on unit carton of the Product as per requirement of local regulation.
2/ SoPC (Summary of Product Characteristics) in English so we can translate into Vietnamese.
3/ Draft CPP (Certificate of Pharmaceutical Product) or Free Sale Certificate (for Food supplement, Cosmetics or Medical Devices). All information on artwork should correspond to those in these legal documents. Therefore it should be provided to us together with original artworks for revising.
Procedures to prepare label for commercial orders
1/ Upon receiving approval from Vietnam MOH for registration dossier of the Product including artwork, we will send manufacturer copy of the approved artwork.
2/ We will prepare final artwork based on approved artwork and Vietnamese package insert and send to manufacturer for approval. Artwork in commercial order should follow strictly artwork that have been approved by Vietnam MOH, only add Registration number, Mfg. date, Exp. Date, Batch No., Importer name and address.
3/ Manufacturer will send trial prints/proof copy of label (carton, bottle/strip/blister/vial/ampoule, package insert) to us for reviewing. Please note that trial prints must be always in image format with added mock-up Mfg. date and Exp. date.
4/ We will check trial prints and send approval to manufacturer.
5/ Only after getting Doha’s final approval for label that manufacturer can start bulk/mass printing.