EUnetHTA Early Dialogue Secretariat EUnetHTA-HAS@has-sante.fr	Date: Click to select date

Letter of Intent for EUnetHTA Multi-HTA Early Dialogue

Please fill in all the predefined fields as accurately as possible

Unique Product Identifier
*Substance
INN (if available)
Trade name (if available)
Company product code
*Description of the product & mechanism of the action
*Type of product	☐ Chemical ☐ Generic ☐ Antisense ☐ NCE ☐ Others ☐ Bio(techno)logical ☐ Classical biological ☐ Blood derived ☐ Enzyme ☐ Vaccine ☐ Other biologicals ☐ Recombinant DNA derived product ☐ Cytokine ☐ Hormone ☐ Monoclonal antibody ☐ Vaccine ☐ Transgene derived (animal/biopharm) ☐ Other Recombinant ☐ Similar Biological ☐ Neucleic Acid Based ☐ DNA vaccine ☐ Oncolytic virus ☐ Advanced Therapy ☐ Gene therapy ☐ Autologous ☐ Allogenic ☐ Xenogenic ☐ Somatic cell therapy ☐ Autologous ☐ Allogenic ☐ Xenogenic ☐ Tissue-engineered product ☐ Autologous ☐ Allogenic ☐ Xenogenic ☐ Therapeutic, Scientific, or Technical Innovation

Comments:

*Intended indication for the scope of the current ED
Therapeutic field	☐ Cancer ☐ HIV/AIDS ☐ Diabetes ☐ Neurodegenerative disorder ☐ Viral disease ☐ Autoimmune disease/dysfunction ☐ Cardiovascular ☐ Other
*ATC code (broad or detailed if known)	Click to select. or detail here:

Comments:

*Applicant	Company Name: Address: Country:
*Contact Person details	Title and Name: Direct Tel: Fax: Email:
*Alternate Contact Person details	Title and Name: Direct Tel: Fax: Email:
Financial Contact Person details	Title and Name: Direct Tel: Fax: Email:

Comments:

Small and Medium Sized Enterprises (SME)	☐ NO – N/A
☐ YES
- SME Number:

Consultant on behalf of Applicant (if applicable)	Title and Name: Direct Tel: Fax: Email:
Contact Person details	Title and Name: Direct Tel: Fax: Email:
Alternate Contact Person details (if applicable)	Title and Name: Direct Tel: Fax: Email:
Letter of authorisation from applicant	☐ NO (to be provided within 15 days) ☐ YES (please attach)

*Aimed date of the face-to-face meeting (please refer to the EUnetHTA Multi-HTA Early Dialogues procedure for the full timeline)

Comments:

Participating HTABs (preference)
Clinical trial phase(s) for which Multi-HTA ED is requested
Are the trial(s) for which advice is requested on-going?	☐ YES ☐ NO
Does the product represent a new mode of action for this indication?	☐ YES ☐ NO If yes, please describe:
Does the indication target a life-threatening or chronically debilitating disease?	☐ YES ☐ NO If yes, please describe:
Does the product target an unmet need?	☐ YES ☐ NO If yes, please describe:
Summary of safety and efficacy annexed	☐ YES ☐ NO

Comments:

Type of request	Early Dialogue: New Request
Other scientific advice or early dialogue (received or planned)	EMA Scientific Advice: ☐NO / Not planned ☐ YES Date: Click to select date Previous EUnetHTA or SEED Early Dialogue (ED) ☐NO ☐ YES Date of the ED: Click to select date Other Early Dialogues with individual HTA bodies: ☐NO / Not planned ☐ YES Which countries:

Orphan status	☐ NO – N/A ☐ YES (please fill in additional rows) - Orphan Designation (OD) EU Number: EU/ - OD date:
- Indication for which OD has been granted:

Comments:

Status of the product / pipeline	☐MA Granted in another indication ☐MA not yet granted ☐N/A
Marketing Authorisation (MA) already granted in another indication	Date of MA granting: Route of MA: ☐National Procedure ☐MRP/Decentralised Procedure ☐Centralised Procedure Specify in which indication:
MA not yet granted	MA Application planned date: Route of MA planned: ☐National Procedure ☐MRP/Decentralised Procedure ☐Centralised Procedure (according to Reg. (EC) No 726/2004)

Comments:

Area of advice	☐Clinical (Paediatric only request: ☐)
☐Statistics ☐Safety / Efficacy
☐Economic
Please briefly outline the scope/content of each question, for each area of advice:

Comments:

Important: please send this form in Word format as it is to: EUnetHTA-HAS@has-sante.fr

Do not convert it into PDF.

An additional alternate contact person is requested in case the main contact point is unavailable. All official correspondence will be sent to both contact persons. If a consultant is acting on behalf of the applicant, the alternate contact person details are not requested.

Please provide details of a contact person in case fees will have to be paid to some HTA bodies participating in the Early Dialogue.

Preferences will be taken into account but are not guaranteed.

A summary of available safety and efficacy data for the intended product and indication must be annexed when submitting the letter of intent.

Please check if the questions relate only to Paediatric development.