Vietnam Pharmaceutical Product Registration Form

Streamline Your Vietnam Pharmaceutical Product Registration

Navigating pharmaceutical registration in Vietnam requires detailed documentation, regulatory compliance, and careful coordination between manufacturers, importers, and the Ministry of Health. This Vietnam Pharmaceutical Product Registration Form provides a comprehensive, structured solution for pharmaceutical companies, contract manufacturing organizations (CMOs), and regulatory affairs professionals seeking to register products under Vietnam's Drug Administration Law.

Built for Vietnamese Pharmaceutical Compliance

This template addresses the specific requirements of Vietnam's pharmaceutical regulatory framework, including:

• Complete product identification and classification according to Vietnamese pharmacopoeia standards
• Manufacturing facility certification and GMP compliance documentation
• Detailed active and inactive ingredient declarations with INN nomenclature
• Clinical trial data upload with ethics committee approval references
• Import license and distributor information for foreign manufacturers
• Shelf life, storage conditions, and packaging specifications

From Submission to Approval Tracking

With Paperform's document upload capabilities and conditional logic, you can create a registration workflow that adapts based on product type (generic, branded, biological), manufacturing origin (domestic or imported), and registration pathway (full dossier, abridged, or bioequivalence study).

Connect with Stepper (stepper.io) to automate your post-submission workflow: route applications for internal review, notify quality assurance teams when clinical data is uploaded, update regulatory tracking spreadsheets, and send status updates to stakeholders throughout the 6-12 month registration timeline.

Add Papersign (papersign.com) for secure eSignatures on declarations of conformity, authorized representative agreements, and manufacturer authorization letters—all linked directly to the original application for complete audit trail compliance.

Designed for Regulatory Affairs Teams

Whether you're a multinational pharmaceutical company expanding into the Vietnamese market, a local manufacturer seeking registration renewals, or a regulatory consultancy managing multiple client submissions, this template provides the structure and data capture you need while maintaining the flexibility to adapt to evolving MOH requirements.

Paperform's SOC 2 Type II compliance and secure file handling ensure your sensitive pharmaceutical data, proprietary formulations, and clinical trial information remain protected throughout the registration process.