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
Deadline: Dec 14, 2021