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fda dscsa 2025

FDA extended the DCSCA Deadline for 2025

  In August FDA issued documents for the official extension of DSCSA in order to support the trading partners in meeting upcoming requirements. Furthermore, in October, theย FDA issued an exemption from the enhanced drug distribution security requirements for certain eligible trading partners. Discover the exemptions and...

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e-leaflet medicines

[Blog] Global Scale of Electronic Leaflet Trend

  The leaflet is an integral part of any medicine. Moreover,ย  according to the EU Legislation, it is obligatory to include a package leaflet with all medicinal products, unless all the information required is directly conveyed on the packaging. However, the pharma supply chain and its...

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Serialization deadline in Jordan expanded by JFDA

[Blog] Jordan extended the serialization deadline for September 2024

  Jordan Food and Drug Agency (JFDA) released the notice, extending the deadline for the requirement of implementing Data Matrix and serialization on secondary packaging for regulated pharmaceutical products until 30 September 2024           Another extension   The situation is being rolled forward for another time this year.   The current deadline...

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greece italy eu fmd

[Blog] Italy and Greece – EU FMD Implementation Update

  In less than a year the 6-year extension period for FMD (Falsified Medicines Directive)ย  implementation in Italy and Greece will end. After this date, the FMD 2011/62, the European directive on falsified medicines, will come into force in both countries. Here is an overview of...

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uk track and trace medicines

[Blog] Insights from the UK MHRA Guidance under the Windsor Framework

Navigating Medicinal Product Labelling Changes: Insights from the UK MHRA Guidance under the Windsor Framework             On 29 September 2023, the UK Medicines and Healthcare Products Regulatory Agency (โ€œMHRAโ€) published furtherย guidanceย (โ€œMHRA Guidanceโ€) on changes to labelling and packaging for medicinal products intended for the UK market (including...

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FDA announces compliance policy guidance for drug distribution security

[Blog] DSCSA Postponement for 2024

  Discover what stands behind the DSCSA postponement for 2024 - Key track and trace requirements ahead           In 2023, the FDA announced that the deadline for DSCSA`s enforcement will be extended to November 2024. In the published Compliance Policy Guidance, it is stated that the extension of...

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