See attached spreadsheet of what constitutes a significant change as per EU, US, Canada and Singapore (which I had prepared for our Company sometime back).
The EU guidance may be revised. pls check in the NBMED Guidance docs for the latest ones.
For your case, I would suggest:
- If you have any SOP for significant changes reporting, perform analysis whether it is a significant change or not
- based on the evaluation you need to notify to appropriate stake holders such as regulatory agencies, distributors, customers, suppliers, etc.
- the address change falls under non-significant change, as it doesn;t affect the product quality and safety and no additional risks raised, so there is no need to report to the authority. You can document this justification and file it in Technical File or DHF
- To inform customers and other stakeholders, you can either use a memo-to-file or any form associated with your procedure that is best suitable for this purpose.
Regards,
Sreenu