• TGA has asked all the affected sponsors to update their medicine labels and relevant documentation in accordance with the new ingredient names.

    • - The transition period ends on April 30, 2020

    Let your medicine labels showcase new ingredient names.

    Deadline: Apr 30, 2020

  • EMA’s new EU MDR will be effective from May 26, 2021.

    • In accordance, manufacturers must submit a Clinical Evaluation Report (CER) along with CE Technical File.

    Don’t give it a miss.
    Act now to be compliant!

    Deadline: May 26, 2021

  • The USFDA has extended the Type III DMF’s eCTD submission deadline

    • - May 5, 2020 has been mandated as the new deadline

    How compliant are your eCTD conversions?

    Deadline: May 5, 2020

  • The TGA has introduced new labeling requirements for medicines supplied in Australia.

    • - TGO 91 for standard labels of prescription and related medicines
    • - TGO 92 for standard labels of non-prescription medicines
    • Aug 31, 2020 is the transition deadline.

    Would you like to comply with the new standards?

    Deadline: Aug 31, 2020

  • Australia’s TGA has announced new Product Information (PI) Form, which is going to be mandatory.

    • - The transition deadline is December 31, 2020

    Would you like to reformat the existing PIs?

    Deadline: Dec 31, 2020

  • Health Canada has announced amendments to nutrition labeling, list of ingredient and food colours.

    • - The transition deadline for new requirements ends on December 14, 2021

    Would you like to adopt the
    new requirements?

    Deadline: Dec 14, 2021

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