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eAF - Implementation of Changes for Type IB or Type II applications
eAF - Implementation of Changes for Type IB or Type II applications
Posted
Thu, 01 Feb 2024 10:59:17 GMT
by
Isha Arora
Dr.
Hello,
I would like to raise a concern here please.
In the eAF webform for variations (PLM portal), in the section ''Declaration of the applicant'', in order for the form to be validated, applicant
has to
mention a date for implementation for Type IB or Type II applications.
However, in the old/current format of eAF pdf, mentioning a specific date is not mandatory; the form can be validated with a comment.
Can the eAF webform be aligned to the current existing requirement (not mandatory date), as this raise issues for changes which require long implementation timelines (e.g. CMC changes)
Thank you,
Isha
Posted
Mon, 26 Feb 2024 16:17:31 GMT
by
Kristiina Puusaari
Dear Isha,
I have just rechecked the application to ensure that there are no errors in the rules, and the implementation in the PLM Portal eAF is the same as in the pdf based eAF. It is possible to select from 3 different options, you can simply tick the box 'Next production run', select a date from the calendar or use the free text field to indicate the intended implementation date, this can be text or numbers i.e. a comment can be inserted, however, it is not possible to leave this section empty as it is mandatory to select one of the three options.
Please see a screenshot of this section with the 3 options.
I hope this helps,
Kristiina
changes will be implemented.jpg (27.5 KB)
Posted
Wed, 28 Feb 2024 14:45:12 GMT
by
Isha Arora
Dr.
Thank you for clarifying.
Isha
Posted
Fri, 08 Mar 2024 08:21:37 GMT
by
Estelle Truchet
Good morning,
I am running into the same issue as described above, I have entered the text "upon variation approval" in the free text section, saved the form, but I still have the red banner "please select at least one option in the section "changes will be implemented from" to proceed - the field date is required" (see capture enclosed).
How can I solve this issue ?
Thank you and kind regards,
Estelle
Capture10.PNG (58.7 KB)