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

EUnetHTA Early Dialogue Request Form

Please fill in all the predefined fields as accurately as possible

Type of request	☐ Multi-HTA ☐ Parallel consultation with EMA
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
Products with market authorization in similar indication
Products in development with similar indication
Application type EMA (anticipated):	☐ Initial market application (IMA) ☐ Extension of Indication (EoI) ☐ Line Extension (LE) ☐ First in class (FC) ☐ Priority Medicine (PRIME) ☐ Accelerated access (AC) ☐ Orphan designation (OD) if current OD, please provide: OD number:…. Date:. Indication for which OD has been granted:
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)

Earliest and aimed date of the draft Briefing Book ready for submission (please refer to the EUnetHTA Early Dialogues procedure for the full timeline)
Deadline to receive the final EUnetHTA recommendations (please refer to the EUnetHTA Early Dialogues procedure for the full timeline)

Comments:

Clinical trial phase(s) for which 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:
Data available at the time of the request (Summary of safety and efficacy data to be annexed)
Data available at the beginning of ED procedure (i.e. at time of Final Briefing Package submission - Summary of additional information expected )

Comments:

Other scientific advice or early dialogue (received or planned)	EMA Scientific Advice: ☐ NO ☐ YES Date: Click to select date Other Early Dialogues with individual HTA bodies: ☐ NO / Not planned ☐ YES Which countries:

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	Please briefly outline the scope/content of each question, for each area of advice following topic order proposed below: ☐ Target Population: ☐ Intervention: ☐ Comparator choice: ☐ Outcomes choice: ☐ Study Design including statistical analysis method: ☐ Post-Launch Evidence Generation (only in conjunction with request for pivotal trial): ☐ Health Economics:

Comments:

Important request submission instructions:

Please send this form in Word format do not convert it into PDF.

Requests for Parallel Consultations should be submitted simultaneously to EMA (scientificadvice@ema.europa.eu) and EUnetHTA (eunethta-has@has-sante.fr) via Eudralink

Requests for Multi-HTA EDs should be transmitted using a secure messaging system. If one is not available to the Applicant, they should contact the EUnetHTA ED Secretariat as early as possible so that a secure link can be provided.

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.

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

A summary of expected information (study phase, high level design with minimum information on Population Intervention Comparator Outcomes (PICO) for the intended product and indication must be annexed when submitting the letter of intent.