MA and Signals

Dear members,

I have a general question on signal management. As an MAH in the UK, do we have to conduct signal management activities for products that we do not currently market?

 

Dear Member

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.

Kind regards,

PIPA

[Author]

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