Serialisation: South Africa will join the fight against counterfeiting

Monitoring the worldwide pharma Track and Trace regulations is key for accurate production planning and forecasting. Pharmaceutical companies exporting high volumes of their production output consider regulatory compliance to be a crucial requirement to operate successfully on the foreign markets. For example, companies shipping their products to South Africa must plan for rearrangement of their packaging process to meet the upcoming South African requirements described in the government notice No. 9881 of the National Department of Health. Although this requirement is not as actively discussed, as the EU FMD and the US DSCSA regulations, it is certainly worth of paying attention to for companies exporting to South Africa. These are quite a few, as Eurostat2, the statistical office of the European Union, estimated the exports of pharmaceuticals from the EU to South Africa to add up to 1,185 Million Euro in 2017.

1South African Department of Health (2017). Request for information: National Department of Health phased implementation of GTIN-14 DataMatrix Barcodes (No. 988). Government Gazette (Vol. 627, No. 41114).

2European Commission, Directorate-General for Trade (2018). European Union, Trade in goods with South Africa.

The government notice outlines implementation of GTIN-14 DataMatrix that will replace an EAN-13 barcode on the tertiary packaging (i.e. shipping cases etc.) by the end of 2018. The DataMatrix should then include GTIN, batch/lot and expiry date. Furthermore, South Africa will join the global fight against counterfeit medicines by implementing serialisation of the secondary and tertiary packaging level by 2022.

The regulation will be phased leaving healthcare manufacturers with enough time for adequate preparation. Wipotec and USS Pactech, our South African partner, actively support the country’s healthcare sector in this transition and help pharmaceutical companies around the world to be compliant with global serialisation regulations.

The implementation timeline:

Tertiary packaging trade item (pallet or case)

Application Identifier Implementation Date
(01) GTIN Dez 30, 2018
(10) BATCH /LOT Dez 30, 2018
(17) EXPIRATION DATE Dez 30, 2018
(21) SERIAL NUMBER Jun 30, 2022

Secondary packaging (multi pack and/or single pack carton)

Application Identifier Implementation Date
(01) GTIN Jun 30, 2020
(10) BATCH /LOT Jun 30, 2020
(17) EXPIRATION DATE Jun 30, 2020
(21) SERIAL NUMBER Jun 30, 2022
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