Are there any specific requirements for Materiovigilance in terms of an Materiovigilance-officer residing in South Africa, or having a nominated person who’s contact details are submitted to SAHPRA, like there is with PV? Would it be “legally” allowed for someone in the Global Company Headquarters or Regional Office to perform this function, or does it have to be a local person?

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  • Are there any specific requirements for Materiovigilance in terms of an Materiovigilance-officer residing in South Africa, or having a nominated person who’s contact details are submitted to SAHPRA, like there is with PV? Would it be “legally” allowed for someone in the Global Company Headquarters or Regional Office to perform this function, or does it have to be a local person?

This should be your local Authorised Representative

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