Mikael Zad Head of Regulatory Affairs

When re-activating a product, i.e. updating a notice from dormant status to active via IRIS, an annual update shall be submitted simultaneously. Will this affect the birthday date?

Thank you for quick response Anna. In my example, would it be possible to move the birthday date to an earlier month (as early as January), and from when would that be possible in that case?

In the FAQ for parallel distribution on EMA website, the example in heading 8 for section  "Safety updates/bulk changes/annual update" states:

"Example: A parallel distributor holds the following PD notice for ‘product X’ tablets issued on: 5 March 2006, 27 July 2008, 22 December 2008 and 19 February 2013. The first “birthday date” is February 2014 and the company is required to submit an annual update before the end of February 2014."

Let's say in theory there are two PD notices that are issued for product X, having the same pharmaceutical form AND same Member State of Destination. What would have happened if the first PD notice was held on December 2021, and the second (and last) in January 2022? Would that mean that the first birthday date is in January, and that the first annual update for both PD notices would be sent in earliest January 2023 (i.e. longer than 12 months for submitting the first annual update for the first PD notice)?
 

Dears,

Are parallell distributors obliged to not cover the original batch and expiry of the source product? Where can more information about this be found on the EMA website?

Kind regards,
Mikael