Bioequivalence and Bioavailability Forum

Hi everyone,
In Brazil we are implementing the guideline about generic transdermal products and I have some doubts about the EMA Guideline.

(1) About the sensitisation and irritation test, is it dependent on how the medication is used or should it always be done as described in the guide, a patch every day even if the patch is to be used for more than 24 hours?

(2) Is a multiple dose study necessary if accumulation is observed or is there any other condition that would dispense this study with transdermal patches?

I would appreciate a lot any kind of help.
Thanks in advance!

Kelen