Posted Wed, 12 Jan 2022 14:39:35 GMT by Mikael Zad Head of Regulatory Affairs

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)?
 

Posted Thu, 13 Jan 2022 12:40:17 GMT by Anna Fiodorova
Birthday dates for the notices issued after 01/05/2013 are established according to the date of the first PD notice issued after that 01/05/2013.

Quote from FAQ for parallel distribution: "The “birthday date” of an annual update is the date by when an annual update should be submitted. The first “birthday date” is counted from the date of the last PD notice issued for a certain pharmaceutical form of a particular product for each Member State of destination, prior to 01/05/2013. When no PD notice for a certain pharmaceutical form of a particular product for each Member State of destination had been issued prior to 01/05/2013, the birthday date is calculated from the date of the first PD notice issued after 01/05/2013​​​​"

In case of your example, the first annual update should be submitted before the end of December 2022.
Posted Thu, 13 Jan 2022 12:58:23 GMT by Mikael Zad Head of Regulatory Affairs
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?
Posted Mon, 24 Jan 2022 15:24:54 GMT by Anna Fiodorova
Yes, an annual update for both presentations can be submitted earlier, i.e. in January 2022, instead of December 2022. 
A birthday date can be brought forward or delayed slightly, by simply submitting an annual update. The submission date will then become a new birthday date for this particular pharmaceutical form and member state of destination of the product.
Posted Tue, 25 Jan 2022 06:42:37 GMT by 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?
Posted Thu, 27 Jan 2022 12:37:35 GMT by Anna Fiodorova
Yes, the submission date becomes the new birthday date, as explained above.

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