*Requirement for EMA NO meeting YES (specify preferred week for meeting): If yes please indicate if there are any NO YES regulatory topics to be discussed: Aimed start of the procedure at SAWP meeting Comments: *Type of request Previous advices received This request is a follow-up to the advice given by the CHMP. Procedure number: EMEA/H/SA/ Other CHMP Scientific Advice (s) given to this product. Procedure number: EMEA/H/SA/ Previous Scientific Advice(s) received by relevant Competent Authorities, EU or non-EU (including exact dates): Previous briefing meeting with EMA: Particular request (choose if Request relating to Conditional marketing authorisation applicable) Advice relating to “Justification” criteria Advice relating to development WHO Art. 58 FDA Parallel advice Request on general issues (broader advice) Request relating to marketing authorisation under “Exceptional circumstances” Advice relating to “Justification” criteria Advice relating to development Request for includes (choose if Process Analytical Technology applicable) Modelling and Simulation Comments: Parallel Consultation EMA EUnetHTA Participating HTAs (preference) Request for ED includes Economic analysis YES NO Involvement of Early Dialogue YES NO Working Party (EDWP) preferred Exchange of documents Please tick if the Applicant consents to share between EMA and EUnetHTA Administrative information List of Issues Final Advice Letter Clinical trial phase(s) for which Parallel Consultation is requested: Are the Trial(s) for which advice YES NO is requested ongoing? Does this represent a new YES NO mechanism of action for in this indication? Does the indication target a YES NO or chronically debilitating disease? Does the indication target an YES NO Unmet need? Summary of safety and efficacy YES NO annexed Comments Post-Authorisation Studies Centrally Authorised Products (CAPs)
*Requirement for EMA meeting NO YES (specify preferred week for meeting): If yes please indicate if there are any NO YES regulatory topics to be discussed: Aimed start of the procedure at SAWP meeting Comments: *Type of request Previous advices received This request is a follow-up to the advice given by the CHMP. Procedure number: EMEA/H/SA/ Other CHMP Scientific Advice (s) given to this product. Procedure number: EMEA/H/SA/ Previous Scientific Advice(s) received by relevant Competent Authorities, EU or non-EU (including exact dates): Previous briefing meeting with EMA: Particular request (choose if applicable) Request relating to Conditional marketing authorisation Advice relating to “Justification” criteria Advice relating to development WHO Art. 58 FDA Parallel advice Request on general issues (broader advice) Request relating to marketing authorisation under “Exceptional circumstances” Advice relating to “Justification” criteria Advice relating to development Request for includes (choose if applicable) Process Analytical Technology Modelling and Simulation Comments: Parallel Consultation EMA EUnetHTA Participating HTAs (preference) Request for ED includes Economic analysis YES NO Involvement of Early Dialogue Working Party (EDWP) preferred YES NO Exchange of documents between EMA and EUnetHTA Please tick if the Applicant consents to share Administrative information List of Issues Final Advice Letter Clinical trial phase(s) for which Parallel Consultation is requested: Are the Trial(s) for which advice is requested ongoing? YES NO Does this represent a new mechanism of action for in this indication? YES NO Does the indication target a or chronically debilitating disease? YES NO Does the indication target an Unmet need? YES NO Summary of safety and efficacy annexed YES NO Comments Post-Authorisation Studies Centrally Authorised Products (CAPs)