BIOVIA’s Post

🔍 DSCSA Compliance FAQ Series: FAQ #2 Do I still need to verify if I only order through my wholesaler? Yes, you still need to verify. DSCSA mandates verification of all transacted product and their transaction data. Even without DSCSA, it's crucial to verify wholesaler orders to catch any exceptions early. Learn more about DSCSA compliance and optimization with ConsortiEX here: https://hubs.ly/Q02tYFXb0

CECIP participated in the Joint Activity for the Compliance of Products (JACOP) project, which focuses among other sectors on NAWIs. The project is a collaboration of Market Surveillance Authorities (MSAs), CECIP and the European Commission. The objective of the joint project is to promote compliance, identify non-compliance, raise awareness, and provide guidance on EU harmonization. We have developed a guidance document “Guide for online sellers & online platforms of Non-Automatic Weighing Instruments (NAWIs) for the EU single market” to provide guidance to persons/business selling NAWIs for commercial purposes via online platforms in the EU single market and to ensure that sellers are aware of the requirements of the NAWI Directive 2014/31/EU. CECIP aims to ensure consumer protection and achieve a level playing field between manufacturers. Please share the guide with fulfilment service providers, distributors, and website providers to ensure product compliance. https://lnkd.in/ewnXnHmR #compliance  #harmonization #consumerprotection

Does your Health system want: "Worry-Free Compliance" even if you have this question: "My facility can not handle any additional barcode scans, how can I stay compliant?" - Talk with ConsortiEX, VS reading/believing False charts!

DSCSA IMPLEMENTATION: FDA & INDUSTRY COLLABORATION TABLE I would be remiss if I did not recognize and applaud all the well-meaning and dedicated people in FDA and industry who have worked so hard over the last 11 years to bring DSCSA interoperability into the implementation “red zone” and get us so close to the goal line, even as the goal posts had to be moved a few times along the way. There has been great collaboration, discussion, and debate across trading partners along this journey. I put together a companion table to the enforcement table to highlight the steady stream of communication and listening that has helped progress DSCSA implementation…

🔍 DSCSA Compliance FAQ Series: FAQ #4 My facility can not handle any additional barcode scans, how can I stay compliant? ConsortiEX’s ScanCast™ tackles the challenge of excessive scanning in pharmacies. By eliminating redundant scans from your receiving process, ScanCast™ offers a simplified solution for maintaining compliance. Learn more about DSCSA Compliance and ScanCast™ here: https://hubs.ly/Q02tYVK30

💡 Learn how the New GPSR is Changing Product Safety Standards in our upcoming webinar. 💼 Whether you’re a manufacturer, distributor, or retailer, the new General Product Safety Regulation (GPSR) changes will cover all consumer products sold in the EU, online and offline, and will impact how you do business. 🗓️ Join us on Thursday 24 October for an informative webinar where we’ll dive deep into the key updates, new requirements, and how your business can stay compliant. Secure your place today ➡️ https://ow.ly/UO0z50TEcG5 #EssexBusiness | #TradeTuesday | #GPSR | #ProductSafety | #EURegulations | #BusinessCompliance | #ConsumerProtection | #WebinarAlert

Just released the latest five minutes of guidance video about the 340B Alternative Distribution model and DSCSA. The evolving alternative distribution model is tied up in litigation and practice and if it is not addressed before full implementation of DSCSA it could be disruptive to the program and patient's access to medications. #DSCSA #340B #FDA #Regulation #HealthcareSupplyChain

Our 2nd DSCSA Blog in 2 Days! We support FDA's decision to exempt portions of DSCSA further. While there is always room for improvement in something this complicated, it allowed activity to pick up significantly this year while avoiding clear indications of impacts to product flow approaching in November. We encourage clients to continue expanding participation in the many industry efforts underway at GS1, PDG, HDA, NABP and others. These are now heavily focussed on exception management, expanding interoperability, and sharing lessons learned. Here is to the drive to full compliance in 2025! https://lnkd.in/gY9cSeFt #dscsa #FDA #pharmacueticals

#ICPHSO 2024 International Symposium Session: Bridging the Gap: Linking Policy to Action for Product Recalls #productsafety #ICPHSO24 #IPSW2024

#ICPHSO 2024 International Symposium Session: Bridging the Gap: Linking Policy to Action for Product Recalls #productsafety #ICPHSO24 #IPSW2024