The South African Health Products Regulatory Authority (SAHPRA) is developing an e-services portal for the industry. On 17 & 24 August, SAHPRA conducted training on the service desk tool ahead of the envisioned pilot rollout of 5 September: service.sahpra.org.za.
User forms (which will be made available on the SAHPRA website) should be submitted in order to create user profiles for each company and should be submitted as soon as possible. At this point, only one user will be allocated to the company (preferably the Authorised Representative), but SAHPRA is looking at the feasibility of additional users and will likely send out a survey to this end.
Once live the user can sign in and access a dashboard with tasks, company performance, and a contact list. Under task there is a list of service requests which can be used to submit a request to SAHPRA and the service can then be followed up via the system. Some of the service requests include establishment licences, general information requests, borderline product submissions, and medical device registration (not yet active). Additional service requests will continue to be added as they evolve. The system will allow you to upload relevant documentation including proof of payment. The requests will then be allocated to a relevant resource within SAHPRA.
This e-services portal is an effort to streamline and track SAHPRA service requests. A training manual and FAQ are in development for those who were not able to attend the training session. These will be circulated as soon as SAHPRA publishes them.