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Health Legislation

Health Legislation

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Guidelines for Registration of Human Vaccines

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.

These guidelines provide the required standards on the establishment, registration, management and supervision of early childhood development (ECD) services. These are to ensure the effective implementation of ECD programmes.

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