Foreign herbal medicine dossiers required following documents:
Administration documents:
Certificate of Pharmaceutical Product (CoPP)
Package artwork and patient information leaflet of proposed product.
Package artwork and patient information leaflet of product which is actually circulated in origin country.
Documents to evaluate GMP compliance of manufacturer
Authorization letter (for 8A/TT or form 8B/TT) is required to legalized at Vietnam Embassy.
Legal documents of manufacturer of herbal materials and intermediate product of herbal materials (GMP or CEP)
Quality dossiers
Materials
a) Manufacturing process
b) Specification and analytical methods
c) Certificate of analytical (COA) of materials
Finished product
a) Manufacturing process
– Formulation for a smallest package (name, strength/ concentration/ weight, specification of ingredients)
– Batch formula.
– Flow chart and description in details for manufacturing process
– List of all equipments in manufacturing process and their capacity
– Control in manufacturing process
b) Specification and analytical methods
c) Certificate of analytical (COA) of finished product
d) Package specification: full and detailed descriptions of packing materials, quality specifications, and analytical methods should be provided.
e) Documents on stability studies according to ASEAN guideline about stability study.
For new herbal drug product
It is also required to submit pre-clinical dossier and clinical dossier according format of ASEAN (ACTD) or ICH-CTD.