These Instructions determine the duties and functioning of committees in charge of management of public or subsidised health facilities. These instructions apply to the following committees of health facilities: Committee of a Referral Hospital; Committee of a Provincial Hospital; Committee of a District Hospital; Committee of a Specialised Hospital; Committee of a Medicalised Health Centre; and Committee of a Health Centre.
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.