Posted Tue, 13 Apr 2021 12:18:16 GMT by Stephanie Pham Dr
Hello,

I have a question related to a request for Protocol assistance for one molecule under multiple ODDs (subsets of condition).  
In the system I can only select one ODD (only subset of the condition) related to the molecule.   

Question: 
- Do I need to submit only once PA request under one ODD (of subset) or should I submit multiple PA request for each of the ODD ?
- If the first option is appropriate, where do I need to report other relevant ODD designations? 

Thanks,
Kind regards
Posted Tue, 13 Apr 2021 15:27:25 GMT by Tarita Toufexi Ms
Protocol Assistance is provided for a single ODD and the system is designed accordingly to allow only one designation.
If you have questions only on one indication you can select the relevant ODD.
If you have questions on more than one indication, multiple requests should be created.
However there can be exceptions depending on the content of the briefing document (broad advices not indication specific).
For these exceptions please contact directly the Scientific Advice office for guidance at scientificadvice@ema.europa.eu.
     

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