Please note that the response to your query represents the views and suggestions of the PIPA Committee Members and are intended as guidance. Please also refer to guidelines and your own company procedures.
As per GVP Module IX Signal Management, The marketing authorisation holder in the EU should continuously monitor the safety of their medicinal products and inform the authorities of any new information that might have an impact on the marketing authorisation.
We hope this helps.
Necessary cookies are absolutely essential for the website to function properly. This category only includes cookies that ensures basic functionalities and security features of the website. These cookies do not store any personal information.
Any cookies that may not be particularly necessary for the website to function and is used specifically to collect user personal data via analytics, ads, other embedded contents are termed as non-necessary cookies. It is mandatory to procure user consent prior to running these cookies on your website.