Anna Fiodorova

This user role is not available for the "Parallel distribution" process types / submissions.

Thank you for your question.
The issue with the new products/product presentations not always being visible in IRIS will be addressed by a new routine for data integration which is expected to be deployed within the next couple of weeks.

Thank you for your feedback. We will take it into consideration when planning future improvements.
Completed submissions can be found in 'Completed Submissions' section in IRIS.

<br> Thank you for your question.<br> We suggest that you upload the Excel file once again. Please refer to recently updated&nbsp;<a href="https://iris.ema.europa.eu/forums/whats-new/141d48a7-b31e-ec11-b76a-0003ff4a48b7">Questions and answers on Marketing Status reporting submissions&nbsp;· IRIS (europa.eu)</a> for more frequent mistakes which lead to submission validation issues.<br> If the submission is neither completed, nor you receive validation error email, please follow the guidance provided in the Q&amp;A.

Thank you for your question.&nbsp;<br> We would like to advise you to visit your draft submission, re-upload the file and attempt to complete the submission process. Please refer to the updated IRIS User guide as well as the Q&amp;A for most recent mistakes and proposed actions.<br> Should submission case remain open for more than an hour without validation error email, please log a Service Desk ticket with detailed explanation, (draft)submission number and attach the Excel file.&nbsp;

Once the submission is invalidated, the case is closed. Therefore you need to make a new submission and upload the corrected file.

Yes, the submission date becomes the new birthday date, as explained above.

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.

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.

For the requirements on the batch numbers for the parallel-traded products, please refer to Chapter 5 Question 5 ‘What are the requirements for batch numbers appearing on the packaging of medicinal products subject to parallel trade?’ of the Guidance on good manufacturing practice and good distribution practice: questions and answers.