--- title: Blog | Serialization | CosmoTrace | Regulations description: Regulations | Industry Information related to Pharmaceutical Serialization, News and Updates for Regulatory Affairs and Track & Trace. Serialization Consulting Services. --- +44 203 097 1597 [info@cosmotrace.com](mailto:info@cosmotrace.com) - - - - [![Cosmotrace](https://blog.cosmotrace.com/hs-fs/hubfs/raw_assets/public/CosmoTrace_Oct2021/images/cosmotrace-2.png?width=630&height=209&name=cosmotrace-2.png "Cosmotrace")](https://www.cosmotrace.com/) - [Home](https://www.cosmotrace.com/) - [About Us](https://www.cosmotrace.com/about-us/) - [Careers](https://www.cosmotrace.com/pages/careers/) - [Services](https://www.cosmotrace.com/our-services/) - Compliance Focused - [Misalignment Exceptions Management (US DSCSA)](https://www.cosmotrace.com/our-services/misalignment-exceptions-management-us-dscsa/) - [EU Alert Management](https://www.cosmotrace.com/our-services/eu-alert-management/) - [Middle East Serialization Consulting](https://www.cosmotrace.com/our-services/middle-east-serialization-consulting/) - [China Reporting Services](https://www.cosmotrace.com/our-services/china-reporting-services/) - Business Operations Focused - [Master Data Management](https://www.cosmotrace.com/our-services/master-data-management/) - [Trade Partner Onboarding](https://www.cosmotrace.com/our-services/trade-partner-onboarding/) - [Level 4 System Validation](https://www.cosmotrace.com/our-services/level-4-system-validation/) - [Serialization System Health Check](https://www.cosmotrace.com/our-services/serialization-system-health-check/) - Business Processes Outsourcing - [Managed Services CoE](https://www.cosmotrace.com/our-services/managed-services-coe/) - [US DSCSA Ti Digitization](https://www.cosmotrace.com/our-services/us-dscsa-ti-digitization/) - [Our Solutions](https://www.cosmotrace.com/solutions/) - [Traceware](https://www.cosmotrace.com/solutions/traceware/) - [nTrack](https://www.cosmotrace.com/solutions/ntrack/) - [Clients](https://www.cosmotrace.com/clients/) - [Blog](https://www.cosmotrace.com/blog/) - [Serialization](https://www.cosmotrace.com/blog/serialization) - [Digital](https://www.cosmotrace.com/blog/digital) - [News](https://www.cosmotrace.com/blog/news/) - [Contact](https://www.cosmotrace.com/contact-us/) - - - - - [Home](https://www.cosmotrace.com/) - [About Us](https://www.cosmotrace.com/about-us/) - [Careers](https://www.cosmotrace.com/pages/careers/) - [Services](https://www.cosmotrace.com/our-services/) - Compliance Focused - [Misalignment Exceptions Management (US DSCSA)](https://www.cosmotrace.com/our-services/misalignment-exceptions-management-us-dscsa/) - [EU Alert Management](https://www.cosmotrace.com/our-services/eu-alert-management/) - [Middle East Serialization Consulting](https://www.cosmotrace.com/our-services/middle-east-serialization-consulting/) - [China Reporting Services](https://www.cosmotrace.com/our-services/china-reporting-services/) - Business Operations Focused - [Master Data Management](https://www.cosmotrace.com/our-services/master-data-management/) - [Trade Partner Onboarding](https://www.cosmotrace.com/our-services/trade-partner-onboarding/) - [Level 4 System Validation](https://www.cosmotrace.com/our-services/level-4-system-validation/) - [Serialization System Health Check](https://www.cosmotrace.com/our-services/serialization-system-health-check/) - Business Processes Outsourcing - [Managed Services CoE](https://www.cosmotrace.com/our-services/managed-services-coe/) - [US DSCSA Ti Digitization](https://www.cosmotrace.com/our-services/us-dscsa-ti-digitization/) - [Our Solutions](https://www.cosmotrace.com/solutions/) - [Traceware](https://www.cosmotrace.com/solutions/traceware/) - [nTrack](https://www.cosmotrace.com/solutions/ntrack/) - [Clients](https://www.cosmotrace.com/clients/) - [Blog](https://www.cosmotrace.com/blog/) - [Serialization](https://www.cosmotrace.com/blog/serialization) - [Digital](https://www.cosmotrace.com/blog/digital) - [News](https://www.cosmotrace.com/blog/news/) - [Contact](https://www.cosmotrace.com/contact-us/) - - - - [![The First Step Towards Pharmaceutical Serialization in Oman](https://blog.cosmotrace.com/hubfs/Pharmaceutical%20Serialization%20Oman%20-%20Jun%2019%20-%20Featured%20Image.jpg)](https://blog.cosmotrace.com/serialization/pharmaceutical-serialization-in-oman) ## [The First Step Towards Pharmaceutical Serialization in Oman](https://blog.cosmotrace.com/serialization/pharmaceutical-serialization-in-oman) Jun 20, 2025 | [Serialization](https://blog.cosmotrace.com/serialization/tag/serialization), [Regulations](https://blog.cosmotrace.com/serialization/tag/regulations) Pharmaceutical serialization has become a crucial global initiative to combat counterfeit drugs, improve patient safety, and enhance supply chain... [![Italy's Transition from Bollino to EU-FMD: Proposed Deadline Extension and Industry Implications](https://blog.cosmotrace.com/hubfs/Italy%20Bollino%20EU%20FMD%20Deadline%20-%206-2-25%20-%20CosmoTrace%20-%20Blog.jpg)](https://blog.cosmotrace.com/serialization/italy-transition-from-bollino-to-eu-fmd-proposed-deadline-extension-and-industry-implications) ## [Italy's Transition from Bollino to EU-FMD: Proposed Deadline Extension and Industry Implications](https://blog.cosmotrace.com/serialization/italy-transition-from-bollino-to-eu-fmd-proposed-deadline-extension-and-industry-implications) Feb 7, 2025 | [Serialization](https://blog.cosmotrace.com/serialization/tag/serialization), [Regulations](https://blog.cosmotrace.com/serialization/tag/regulations) Reference: 19th Legislature - 10th Permanent Commission - Summary report no. 247 of 26/11/2024 (Accessed on February 6, 2025.... [![Italy’s Transition from Bollino to FMD: Challenges and Preparation Guide for Pharmaceutical Manufacturers](https://blog.cosmotrace.com/hubfs/Italy%20Bollino%20-%2024-1-25%20-%20CosmoTrace%20-%20Blog%20%E2%80%93%202.jpg)](https://blog.cosmotrace.com/serialization/italy-transition-from-bollino-to-fmd-challenges-and-preparation-guide-for-pharmaceutical-manufacturers) ## [Italy’s Transition from Bollino to FMD: Challenges and Preparation Guide for Pharmaceutical Manufacturers](https://blog.cosmotrace.com/serialization/italy-transition-from-bollino-to-fmd-challenges-and-preparation-guide-for-pharmaceutical-manufacturers) Jan 24, 2025 | [Serialization](https://blog.cosmotrace.com/serialization/tag/serialization), [Regulations](https://blog.cosmotrace.com/serialization/tag/regulations) Italy is embarking on a significant shift in its pharmaceutical regulation by transitioning from the Bollino system to the European Union’s Falsified... [![Overview of Indonesia’s Pharmaceutical Serialization Regulations](https://blog.cosmotrace.com/hubfs/Indonesia%E2%80%99s%20Pharmaceutical%20-%202-1-25%20-%20CosmoTrace%20-%20Blog%20%E2%80%93%203.jpg)](https://blog.cosmotrace.com/serialization/overview-of-indonesias-pharmaceutical-serialization-regulations) ## [Overview of Indonesia’s Pharmaceutical Serialization Regulations](https://blog.cosmotrace.com/serialization/overview-of-indonesias-pharmaceutical-serialization-regulations) Jan 3, 2025 | [Serialization](https://blog.cosmotrace.com/serialization/tag/serialization), [Pharmaceutical](https://blog.cosmotrace.com/serialization/tag/pharmaceutical), [Regulations](https://blog.cosmotrace.com/serialization/tag/regulations), [Compliance](https://blog.cosmotrace.com/serialization/tag/compliance) The Indonesian Food and Drug Authority (Badan Pengawas Obat dan Makanan) or Badan POM, also known as the Indonesian FDA, is a government agency in... [![US Drug Supply Chain Security Act (DSCSA) Waivers, Exceptions, and Exemptions - WEE’s](https://blog.cosmotrace.com/hubfs/US-Drug---banner-2.jpg)](https://blog.cosmotrace.com/serialization/us-drug-supply-chain-security-act-dscsa-waivers-exceptions-and-exemptions-wees) ## [US Drug Supply Chain Security Act (DSCSA) Waivers, Exceptions, and Exemptions - WEE’s](https://blog.cosmotrace.com/serialization/us-drug-supply-chain-security-act-dscsa-waivers-exceptions-and-exemptions-wees) Dec 20, 2024 | [Serialization](https://blog.cosmotrace.com/serialization/tag/serialization), [Pharmaceutical](https://blog.cosmotrace.com/serialization/tag/pharmaceutical), [Regulations](https://blog.cosmotrace.com/serialization/tag/regulations), [Compliance](https://blog.cosmotrace.com/serialization/tag/compliance) The US DSCSA, enacted in 2013, aims to create a system for tracking prescription drugs as they are distributed within the United States. The act is... [![The Importance of Master Data Management in Pharmaceutical Track & Trace](https://blog.cosmotrace.com/hubfs/Track-%26-Trace--banner.jpg)](https://blog.cosmotrace.com/serialization/the-importance-of-master-data-management-in-pharmaceutical-track-trace) ## [The Importance of Master Data Management in Pharmaceutical Track & Trace](https://blog.cosmotrace.com/serialization/the-importance-of-master-data-management-in-pharmaceutical-track-trace) Dec 13, 2024 | [Serialization](https://blog.cosmotrace.com/serialization/tag/serialization), [Pharmaceutical](https://blog.cosmotrace.com/serialization/tag/pharmaceutical), [Regulations](https://blog.cosmotrace.com/serialization/tag/regulations), [Compliance](https://blog.cosmotrace.com/serialization/tag/compliance) Serialization involves assigning serial numbers to products or packaging units, requiring a defined set of attributes for tracking and tracing. Master... [![CSV in Pharmaceuticals: Challenges and Solutions](https://blog.cosmotrace.com/hubfs/CSV-in-Pharmaceuticals-Challenges-and-Solutions--banner-2.jpg)](https://blog.cosmotrace.com/serialization/csv-in-pharmaceuticals-challenges-and-solutions) ## [CSV in Pharmaceuticals: Challenges and Solutions](https://blog.cosmotrace.com/serialization/csv-in-pharmaceuticals-challenges-and-solutions) Dec 6, 2024 | [Serialization](https://blog.cosmotrace.com/serialization/tag/serialization), [Pharmaceutical](https://blog.cosmotrace.com/serialization/tag/pharmaceutical), [Regulations](https://blog.cosmotrace.com/serialization/tag/regulations), [Compliance](https://blog.cosmotrace.com/serialization/tag/compliance) Pharmaceutical manufacturers face several challenges specific to Computer System Validation (CSV) due to the industry's stringent regulatory and... [![UAE TATMEEN - Pharmaceutical Drug Traceability](https://blog.cosmotrace.com/hubfs/UAE-TATMEEN---Pharmaceutical-Drug-Traceability-2.jpg)](https://blog.cosmotrace.com/serialization/uae-tatmeen-pharmaceutical-drug-traceability) ## [UAE TATMEEN - Pharmaceutical Drug Traceability](https://blog.cosmotrace.com/serialization/uae-tatmeen-pharmaceutical-drug-traceability) Nov 22, 2024 | [Serialization](https://blog.cosmotrace.com/serialization/tag/serialization), [Pharmaceutical](https://blog.cosmotrace.com/serialization/tag/pharmaceutical), [Regulations](https://blog.cosmotrace.com/serialization/tag/regulations), [Compliance](https://blog.cosmotrace.com/serialization/tag/compliance), [Aggregation](https://blog.cosmotrace.com/serialization/tag/aggregation) The UAE Ministry of Health and Prevention issued Legislative Decree No. (73) of 2021 on June 14, 2021, regarding Pharmaceutical Products Traceability.... [![How effective is your EMVO Alert Management Strategy?](https://blog.cosmotrace.com/hubfs/Imported_Blog_Media/How-effective-is-your-EU-Alert-management-strategy-CosmoTrace-Blog-Featured-Image-1.jpg)](https://blog.cosmotrace.com/serialization/how-effective-is-your-emvo-alert-management-strategy) ## [How effective is your EMVO Alert Management Strategy?](https://blog.cosmotrace.com/serialization/how-effective-is-your-emvo-alert-management-strategy) Nov 15, 2024 | [Serialization](https://blog.cosmotrace.com/serialization/tag/serialization), [Regulations](https://blog.cosmotrace.com/serialization/tag/regulations), [Counterfeit](https://blog.cosmotrace.com/serialization/tag/counterfeit) Introduction [![Battling Counterfeit Medicines in Africa: Leveraging Technology for a Safer Supply Chain](https://blog.cosmotrace.com/hubfs/Safer-Supply-Chain-banner.jpg)](https://blog.cosmotrace.com/serialization/battling-counterfeit-medicines-in-africa-leveraging-technology-for-a-safer-supply-chain) ## [Battling Counterfeit Medicines in Africa: Leveraging Technology for a Safer Supply Chain](https://blog.cosmotrace.com/serialization/battling-counterfeit-medicines-in-africa-leveraging-technology-for-a-safer-supply-chain) Nov 8, 2024 | [Serialization](https://blog.cosmotrace.com/serialization/tag/serialization), [Pharmaceutical](https://blog.cosmotrace.com/serialization/tag/pharmaceutical), [Regulations](https://blog.cosmotrace.com/serialization/tag/regulations), [Compliance](https://blog.cosmotrace.com/serialization/tag/compliance) Fake medicines kill almost 500,000 sub-Saharan Africans a year: UNODC report. Prev [1](https://blog.cosmotrace.com/serialization) [2](https://blog.cosmotrace.com/serialization/tag/regulations/page/2) [3](https://blog.cosmotrace.com/serialization/tag/regulations/page/3) [4](https://blog.cosmotrace.com/serialization/tag/regulations/page/4) [5](https://blog.cosmotrace.com/serialization/tag/regulations/page/5) [Next](https://blog.cosmotrace.com/serialization/tag/regulations/page/2) #### Search #### Recent Posts - [Egypt’s Pharmaceutical Track and Trace - From 2019 Pilot to 2025 Nationwide Mandate](https://blog.cosmotrace.com/serialization/egypt-pharma-traceability-2025-mandate) - [Algeria’s 2027 Pharmaceutical Serialization & Aggregation](https://blog.cosmotrace.com/serialization/algeria-2027-pharmaceutical-serialization-aggregation) - [Serialization and Traceability in the Middle East: Navigating a Complex Compliance Landscape](https://blog.cosmotrace.com/serialization/middle-east-serialization-traceability-compliance) - [Sri Lanka Extends Barcode Grace Period for Medicines: What MAHs Need to Know](https://blog.cosmotrace.com/serialization/sri-lanka-barcode-grace-period-extension) - [DSCSA Enforcement Timeline: What Trading Partners Need to Know in 2025](https://blog.cosmotrace.com/serialization/dscsa-enforcement-timeline-2025) - - - - © 2020 CosmoTrace - part of ZeeInx Group