GMIS – Recent News

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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