Republic of South Africa

STATUS: PUBLISHED/ADOPTED

Authorities: Ministry of Health of the Republic of South Africa (NDOH)

Request Source: Regulation

Data Carrier: GS1 Data Matrix

Detail: In the text published by the Ministry of Health of the Republic of South Africa in the Official Gazette on September 15, 2017, it is stated that traceability practices will be met with international standards. In addition, the details of the information to be contained in the 2D code (datamatrix) to be applied are also included in this text. The deadline set by the Republic of South Africa for drug serialization is 30 June 2022.

Update: NAFDAC has developed a 5-Year Traceability Implementation Plan to ensure supply chain visibility by the end of 2024 and strengthen pharmacovigilance activities against the scourge of substandard and counterfeit medicines and medical devices.

 

  • GTIN
  • Batch/lot
  • Expiry Date
  • Serial Number

Links:

https://www.sahpra.org.za/wp-content/uploads/

https://nafdac.gov.ng/traceability/

South Africa Regulations

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