You’re offline. This is a read only version of the page.
Toggle navigation
Home
Forums
Products
Sign in
Home
IRIS Stakeholder Forums
What's New in IRIS
"Dormant" status for Regulatory Entitlements
"Dormant" status for Regulatory Entitlements
Posted
Wed, 26 May 2021 07:56:44 GMT
by
Paolo Tomasi
EMA
The "dormant" status only applies to Parallel Distribution Regulatory entitlements. Please see below the information from the
Parallel Distribution FAQs
.
If the
medicinal product
has not been distributed in parallel for the last 12 months it should be updated to the ‘dormant’ status using the ‘update of
parallel distribution
notice status’ procedure, which does not incur any fees. During the period of dormancy the annual update does not need to be submitted.
The confirmed dormancy will be reflected in the public register of
parallel distribution
. An independent notice will not be sent.
The product will remain ‘dormant’ until the Agency is notified otherwise. To resume distribution of the product after a period of ‘dormancy’, an ‘annual update’ should be submitted.
You must be signed in to post in this forum.