SERIALIZATION & BEYOND...
Thought leadership articles, expert advice, compliance updates and more on serialization, aggregation and business intelligence.
Serialization of medicines in Russia: Deadline is officially extended!
Just before New Year, the federal law No. 346344-7 amending Government Decree 1556 "On approval of the Regulations on the system of monitoring the movement of medicines for medical use" was officially signed and published
Serialization Countdown in Russia: 4 months to go
Serialization requirements in Russia are among if not the most complex in the world. Not only is the timeline very tight - October 1, 2019 for the 12 high-cost nosologies and January 1, 2020 for the rest of the medicinal products
VRS Solutions and their Providers: Is Choice an Option?
When the Healthcare Distribution Alliance (HDA) imagined the Verification Router Service (VRS) concept, the intent was to design a solution that – when built according to VRS specification – would create an ecosystem where different VRS solutions would be interoperable.
Blockchain Technology and Serialization – Interview with Tianna Umann, Microsoft
Tianna Umann, Cross Domain & Blockchain Solution Architect, Microsoft, discusses Blockchain Technology for Serialization and the robust solutions that have been co-developed by Adents and Microsoft to comply with US and EU regulatory requirements.
Additional Insight into the Regulation of Medicines as the Brexit Clock Ticks
As of February 26, 2019, the Medicines and Healthcare products Regulatory Agency (MHRA) has published an update of the guidance note regarding the regulation of medicines, medical devices, and clinical trials if there’s no Brexit deal on March 29, 2019.
Saudi Arabia: Compliance Deadline is Now
The Saudi Food & Drug Authority (SFDA) requested that by the January 7, 2019 deadline all stakeholders (manufacturers, warehouses, pharmacies, medical and dispense centers) register and start reporting all transactions for drug packages placed on the Saudi market to Drug Track & Trace System (DTTS)
Adents Successfully Completes End-to-End Testing for Verification Request Routing (VRS) in the US Market
As part of HDA’s VRS task force, Adents successfully completed end-to-end testing for Verification Request routing including Look-up Directory synchronization. Adents VRS, developed in partnership with Microsoft, is the unique solution currently tested by 4 of the top 5 largest Pharma wholesalers in the US.
Falsified Medicines Directive Compliance: A Quick Overview of Requirements for Wholesalers, Distributors and Logistics Partners
Each passing day brings the pharmaceutical industry closer to the inevitable deadline of February 9, 2019 and the enforcement of serialization, track and trace and reporting requirements imposed by the European Falsified Medicines Directive (FMD) 2011/62/EU to many stakeholders at different levels of the pharmaceutical supply chain.
Verification Router Service – Comply with the Saleable Returns DSCSA requirements
Did you know that on average, 60 million pharmaceutical saleable product returns, equaling $7-8 billion dollars, occur each year in the US market? This year, the establishment of shared standards for sales stream reintegration has become vital for the pharmaceutical industry.
Cloud Serialization Solutions to Solve the Data Management Challenge
Serialization and track & trace processes generate a huge amount of data and pharmaceutical manufacturers need to have sufficient, secure and reliable data storage capacities. Data will need to be indexed and accessible for authorized personnel.
Top 5 Reasons You Should Attend the Adents Serialization Innovation Summit in Philadelphia June 20-21, 2018
The Adents Serialization Summit provides a unique, collaborative forum for pharmaceutical leadership, and technology experts to discuss serialization and traceability in the pharmaceutical industry.
The Falsified Medicines Directive (FMD) 2011/62/EU
To fight against this scourge, the European Union (EU) has put in place directive 2011/62/EU or Falsified Medicines Directive with which pharmaceutical manufacturers (whether MAH or CMO) as well as their supply chain partners will have to comply by early 2019.
Brexit – a bitter pill for the pharma industry?
The impact of Britain leaving the European Union or ‘Brexit’ negotiations is unclear. Where does this leave the pharmaceutical industry and what is the potential impact on the different players: pharma companies, CMOs, patients?