Post Marketing Surveillance Methods – South Africa

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Post Marketing Surveillance Methods – South Africa

Post marketing surveillance (PMS) is the practice of monitoring a pharmaceutical drug or device after it has been released on the market. PMS is a function of the Medicines Control Council (MCC), the regulatory authority in South Africa. The MCC’s PV Committee was comprised of a pharmacist and six external experts from various. Types – Active safety surveillance, Passive safety surveillance, stimulated reporting, Comparative Observational Studies.


  • Who to Report To – National Adverse Drug Event Monitoring Centre, Registrar of Medicines
  • Route of Notification –. It should be sent by post, or by facsimile
  • Report Format – Adverse reaction report form available from the NADEMC or holders of a certificate of registration may use their in-house report forms.
  • Follow-Up Reports Any follow-up information must be cross-referenced to the unique number assigned by the holder of a certificate of registration. A CIOMS format “initial” report which follows a previous (first) communication from the holder of a certificate of registration must be clearly marked that it is a follow up and linked through the applicant-assigned reference number. The only reliable way to minimize the duplication of reports, submitted by holders of a certificate of registration, in the NADEMC’s ADRI database.

Type of ADR report

Time frame for reporting


South African Reports (spontaneous/published/study):

• Serious (expected and unexpected)

• Non-serious (expected and unexpected)

15 days Annually ADR form, Summary report
Foreign Reports (spontaneous/published/study):

• Serious

On request or relating to specific safety issue As appropriate
Notification of Change in Nature, Severity or Frequency or Risk factors 15 days Detailed report (including publications)
New information impacting on benefit-risk profile of product including international regulatory decisions 3 days Detailed report (including publications)


South Africa is having a legal framework in place requiring that adverse events be monitored both actively and passively.


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