Patern Ltd

Standard Regulatory Quality

Structure of dossier

Print

According to existing legislation (Order №426 of MOH of Ukraine) registration dossier for new registration of medicinal product must be submitted in simplified or CTD (common technical document) format.

1. New registration of medicinal product:
Simplified format
CTD-format of the dossier

2. Renewal:
List of required documents for renewal



 

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We are an ISO 9001:2008 certified company

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ACC

Our company is a member oа American Chamber of Commerce