Serialization: South Africa will join the fight against counterfeiting

Monitoring the worldwide pharma Serialization and Aggregation 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 in 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. There 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.

Serialisation start in 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 expiration date. Furthermore, South Africa will join the global fight against counterfeit medicines by implementing serialization of the secondary and tertiary packaging level by 2022. The regulation will be phased in gradually so as to leave healthcare manufacturers with enough time for adequate preparation. WIPOTEC-OCS 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 serialization regulations.

The implementation timeline:

Tertiary packaging trade item (pallet or case)

Application IdentifierImplementation Date
(01) GTINDez 30, 2018
(10) BATCH /LOTDez 30, 2018
(17) EXPIRATION DATEDez 30, 2018
(21) SERIAL NUMBERJun 30, 2022

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

Application IdentifierImplementation Date
(01) GTINJun 30, 2020
(10) BATCH /LOTJun 30, 2020
(17) EXPIRATION DATEJun 30, 2020
(21) SERIAL NUMBERJun 30, 2022
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