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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.
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.
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.