SAHPRA POLICY ON CONDUCT OF CLINICAL TRIALS OF HEALTH PRODUCTS DURING THE CURRENT COVID-19 PANDEMIC1

Kindly note that during the lockdown SAHPRA Clinical Trials Unit will work remotely with limited number of employees.

The correspondence received by email during the lockdown should be submitted once the situation has stabilised (i.e. once SAHPRA reception is opened).

Please see attached SAHPRA’s policy related to COVID 2019.

Please note the bits related to Informed Consent and Social Conduct Communication

Major protocol amendment will ideally require the approvals from SAHPRA and the EC before implementation.

Regarding Deviations, ensure proper documentation.

Please be informed that the attached communication regarding the conduct of clinical trials during COVID-19 pandemic has been submitted for posting on SAHPRA website.

The communication is expected to be available on website later today under the tab COVID-19_ communication to stakeholders.

Disaster Management

Attached are the Government Gazette Disaster Management regulations for your easy reference.

Permit Template for Persons performing Essential Services.

Herewith Form C for completion of the South African Animal Health Association permit for key individuals who may be travelling and are responsible for the performance of essential services.

SAHAA will provide a letter confirming that members applying provide an essential service, should additional confirmation be required.

All Organisations and Employees providing Essential services will need to apply for and hold permits as they travel and go about their work.

The link below provides the portal that the application for the permit can be done online.

Get your permits at the link below:

www.bizportal.gov.za

Kedibone Malatji

Medicines Control Officer

SAHPRA

Telephone: 012 842 7606/7602

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