REQUIREMENTS OF NEW PHARMA REGISTRATION DOSSIER IN VIETNAM
CPP according to WHO-format In case CPP doesn't mention that Manufacturer meets GMP-WHO, GMP-WHO certificate is required. If there are many manufacturers take part in the manufacturing process of finished product, GMP-WHO certificates of all manufacturers are required. CPP need to have: from 01/01/2022 with information: - Drug formulation: It is required to fully state the composition, concentration/content of each pharmaceutical substance, excipients. For soft capsules, hard capsules must have more information about the composition of the capsule shell. - Specification DP, DS, DS manufacturer's name and address - All manufacturers and role of each - Attachments need to certify...
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