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track and trace compliance africa

[Blog] Track and Trace Compliance Landscape in Africa (part 2)

Introducing the second article of the series on Africa's Track and Trace Compliance landscape. In this paper we will look through the Track and trace systems in Zambia, Botswana and South Africa.         Zambia   In late October 2021, the Zambia Medicines Regulatory Authority (ZAMRA) published a draft Guideline...

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Serialization deadline in Jordan expanded by JFDA

[Blog] Serialization deadline in Jordan expanded by JFDA

  JFDA extended the implementation deadline for DataMatrix and serialization on secondary packaging on regulated pharmaceutical products until 30 September 2023.             Journey towards traceability implementation   Jordan announced the implementation of pharma serialization in 2017. The first phase included a transition period during which 2D DataMatrix codes were allowed...

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BPOM announced the e-Labeling Pilot in Indonesia

[Blog] BPOM announced the e-Labeling Pilot in Indonesia

The Indonesian Food and Drug Monitoring Agency (BPOM) has launched an initiative called the e-Labeling Pilot Project which certainly will make a significant impact in the healthcare industry.     Current labelling and packaging regulations     Pharmaceutical products must comply with specific labelling and packaging requirements, including information on indications,...

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MDR-Significant-changes

[Blog] MDR – Significant changes you want to know

In May 2023 Medical Device Coordination Group (MDCG) approved new changes to the design or intended purpose of medical devices. Some of them are considered significant while others are non-significant. Products with certificates issued under the old EU directives can stay on the market during...

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Press release by SoftGroup

SoftGroup at Pharma Kazakhstan International Exhibition 2023

This year SoftGroup was a General Sponsor of the International Congress and Exhibition Pharma Kazakhstan & Central Asia 2023 that took place in Astana, Kazakhstan on the 13th and 14th of June.   SoftGroup was represented by Venelin Dimitrov – CEO, Andrey Atanasov – CRO/ Director Business...

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