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 protects the privacy of the individual and of personal data by regulating the collection and processing of personal information; provides for the rights of the persons whose data is collected and the obligations of data collectors, data processors and data controllers; regulates the use or disclosure of personal information; and provides for related matters.