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Since the latest revision of the vaccine prequalification system, the global use of the common technical document (CTD) format has expanded substantially. The majority of manufacturers have generated a dossier in CTD format for product registration in one or more countries, and many countries that import prequalified medicines require submission of a dossier in CTD format for product registration.
Module 1 contains information not included in Modules 2, 3, 4 or 5 but that is required to assess the product for prequalification purposes. See below for further information and guidance.
Modules 2,3,4 and 5 share the common format and content of dossiers submitted to other authorities, according to the following major headings:
Even if you are still in the planning stages of your project, you are more than welcome to submit a request to us. We can assist you with a quotation or create a proposal for you based on the minimum information you can provide.
