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Pharmacovigilance Requirements in South Africa

How to report?

Physical Address:

Loftus Park Building A (2rd FLOOR)

402 Kirkness Road,

Arcadia Pretoria

South Africa

E-Mail:

 

 

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Is local QPPV mandatory in South Africa?

Yes; every MAH needs to nominate a local Pharmacovigilance Officer in South Africa.

"Responsibilities of the holder’s or applicant’s pharmacovigilance officer should include:

(i) the establishment and maintenance of a system which ensures that information about all suspected adverse reactions, which are reported to the holder or applicant, including to medical representatives and clinical research associates, is collected and collated so that it is accessible at a single point;

(ii) serving as a contact person for the Authority and NADEMC for all matters relating to pharmacovigilance;

(iii) the preparation of the following, either directly or by delegation/supervision, for submission to the authority: - ADR reports; - summary report for both serious and non-serious ADRs occurring in South Africa; - Periodic Safety Update Reports (PSURs) or Periodic Benefit-Risk Evaluation Reports (PBRER), when necessary; - company-sponsored post-registration study reports, when required; and - ongoing pharmacovigilance evaluation during the post-registration period; and

(iv) ensuring that any request from the Authority for additional information deemed necessary for the evaluation of the risk-benefit ratio of medicine, is provided to the Authoritypromptly and in accordance with all requirements,

(v) ensure that all the above responsibilities are met for all old and registered medicines on the Authority's Register that is marketed in South Africa. For products that are no longer marketed, post-marketing surveillance and reporting of ADRs should continue until six months after the expiry date of the last marketed batch."

Reporting safety and quality concerns

Consumers: If you are concerned that you have had an adverse effect/side effect to a medicine, or experienced a quality problem with any type of health product regulated by SAHPRA, you may need to contact your healthcare professional (a nurse, pharmacist, doctor etc) who can advise on any treatment that may be needed. They can also report the issue to SAHPRA on your behalf. Should you wish to report an adverse event by yourself, kindly click here. to access the e-reporting portal. Alternatively, click here to download an adverse drug reaction form and email it to adr@sahpra.org.za. Before completing the form kindly ensure that you first read “information regarding reporting of an adverse event” above to ensure that you provide the information required.

 

Healthcare Professionals: If you wish to report an adverse event or quality issue relating to the use of a health product, kindly click here  to access the e-reporting portal. Alternatively click here to download an ADR reporting form and email it to: adr@sahpra.org.za, or use the Adverse Event Following Immunisation (AEFI) reporting form in case of a vaccine related issue.

Pharmacovigilance Systems - PSMF, QPPV, Training, etc

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RMP Requirements

 

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GUIDELINE FOR ADVERSE DRUG REACTIONS (ADRs) REPORTING FOR HEALTHCARE PROFESSIONALS

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