Manual on the Promotion of Access to Information and Protection of Personal Information Act(POPIA)

The South African Health Products Regulatory Authority (SAHPRA) holds a substantial amount of information that it gathers for its primary function of receiving and processing applications for registration of health products. This information is of interest to the people it affects directly or indirectly, employees or data subjects in general.

The Promotion of Access to Information Act 2 of 2000 (PAIA) reinforces the confidentiality of this information by providing that it must not be disclosed in terms of the Act, except to the person to whom it relates or that person’s authorised representative. In addition, PAIA provides for the confidentiality of various aspects of information, where this would be appropriate or applicable.

Protection of Personal Information Act 4 of 2013 (POPIA) provides for the lawful processing of personal information held by institutions such as SAHPRA. Accordingly, SAHPRA is required to ensure that the processing of Personal Information accords with the dictates of POPIA.

This manual describes procedures for making a request for any of SAHPRA’s records or information in terms of PAIA and POPIA.