These guidelines prescribe data, which is required to be submitted to the National Drug Authority to demonstrate the safety, efficacy and quality of vaccines being applied for market authorization. The guidelines also describe the format (CTD) in which dossiers should be presented in support of the application.
This Act harmonizes and consolidates the law on registration of persons; provides for registration of individuals; establishes a national identification register; establishes a national registration and identification authority; provides for the issue of national identification cards and aliens identification cards and for related matters.