GMIS – Recent News

DSCSA T3 Data Standardization & Documentation Practices
The FDA released the draft guidance which provides a significant amount of detail regarding the standardization of product tracing information, its specific data elements; and recommended documentation practices trading partners may utilize to satisfy their product tracing requirements. This guidance supplements the DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information guidance released in November 2014.
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FDA Key Definitions for Suspect & Illegitimate Product Verification

The FDA released its draft guidance which provides FDA’s interpretation of the terms counterfeit, diverted, fraudulent transaction, and unfit for distribution to aid trading partners in their determination of whether a given product is suspect and/or illegitimate.
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European Medicines Verification Organization (EMVO) Published Onboarding Deadlines
With the deadline for the Falsified Medicines Directive (FMD) approaching, EMVO has issued guidance as it relates to the On-boarding process for manufacturers. This guidance advises all On-Boarding Partners and future On-Boarding Partners that the final opportunity to on-board into EMVO with a guarantee of making compliance deadlines is June 2018.
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European Medicines Verification Organization (EMVO) Published Onboarding Deadlines
With the deadline for the Falsified Medicines Directive (FMD) approaching, EMVO has issued guidance as it relates to the On-boarding process for manufacturers. This guidance advises all On-Boarding Partners and future On-Boarding Partners that the final opportunity to on-board into EMVO with a guarantee of making compliance deadlines is June 2018.
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“USFDA Publishes Guidance of Enforcement Discretion for UDI (Unique Device Identification) Compliance Dates – Class I and Unclassified Devices”
On January 16, 2018, the FDA released a guidance document, Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices. This guidance, with initial intent released in June 2017, describes FDA’s intention with regard to enforcement of these requirements for class I and unclassified devices.
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The Russian Federation Closes in on a Serialized Track and Trace Model
On January 24, 2017, the Government of the Russian Federation and several government agencies announced and released a decree to implement a system for the identification and monitoring of all pharmaceutical products in the Russian market, known as the “Medicines Quality and Safety” project.
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The FDA Has Spoken: Grandfathering Guidance Has Been Released!
The FDA released the Grandfathering policy on November 27, 2017. Although this guidance is exactly two years late (Based on the DSCSA timeline), it provides clear direction on the grandfathering policy.
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