Scientific Advice and Orphan Drug Sector European Medicines Agency – EMEA 7, Westferry Circus London E14 4HB United Kingdom
date:
Letter of intent for request of Scientific Advice (SA) / Protocol Assistance (PA) i
Please fill all the predefined fields as accurately as possible INN (if available) Trade name (if available) Company product code Description of the product & mechanism of action Type of product
Chemical: Generic Antisense NCE Others Bio(techno)logical Classical biological: Blood derived Vaccine Enzyme Other biologicals Recombinant DNA derived product: Cytokine Hormone Monoclonal antibody Vaccine Transgene-derived (animal/biopharm) Other Recombinant Similar biological Nucleic acid-based: Gene Therapy DNA vaccine Oncolytic virus Cell-based: Autologous Allogeneic Xenogeneic Transfected cells Tissue-based: Allogeneic graft Other innovative product or therapy
Comments: Intended Indication Therapeutic field Cancer HIV/AIDS Diabetes Neurodegenerative disorder Viral disease Autoimmune disease/dysfunction Cardiovascular Other Please click here to select; or detail here:
ATC code (broad or detailed if known) Comments: Applicant / Company Contact Person details
Alternate Contact Person details (if applicable) Invoicing details (if different from ii Applicant details) Financial contact person details (if applicable or different from procedure contact person) Purchase order number (if applicable or if already available)
Name: Address: Name: Direct tel: Email: Name: Direct tel: Email: Name: Address: Name: Direct tel: Email: Details:
Fax:
Fax:
Fax:
Comments: Consultant on behalf of Applicant (if applicable) Contact Person details Name of the Company: Address: Name: Direct tel: Fax: Email: Name: Direct tel: Fax: Email: NO (to be provided within 30 days) YES (please attach) NO YES (specify preferred week for meeting):
Alternate Contact Person details (if applicable) Letter of authorisation from applicant
Requirement for EMEA preiii submission meeting Aimed start of the procedure at SAWP meeting Comments: Type of request Previous advices received
Please click here to select
This request is a follow-up to the advice given by the CHMP. Procedure number: Other CHMP Scientific Advice given to this product. Procedure number: Previous Scientific Advice received by relevant Competent Authorities, EU or non-EU (including exact dates): 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) – NB: in this case, pre submission meeting is mandatory Request relating to marketing authorisation under “Exceptional circumstances” Advice relating to “Justification” criteria Advice relating to development
Particular request (choose if applicable)
Comments: Orphan status NO – N/A YES (please fill additional rows) - Orphan Designation (OD) EU Number: EU/ - OD date: - OD application number: EMEA/OD/ - Indication for which OD has been granted: iv - Protocol Assistance Fee waiver requested:
YES
NO
Comments: Small and Medium Sized Enterprises (SME) status NO – N/A YES (please fill additional rows) - SME Number: v - SME fee reduction requested : YES - Additional relevant information:
NO date:
Comments:
Status of the product/pipeline:
Marketing Authorisation (MA) already granted
Date of MA granting: Route of MA: National procedure MRP/Decentralised Procedure
MA not yet granted
Additional EMEA Scientific Advice planned Comments: Area Of Advice
vi
Centralised Procedure Specify in which indication: MA Application planned date: Route of MA planned: National procedure MRP/Decentralised Procedure Centralised Procedure (according to Reg. (EC) No 726/2004) NO YES; planned date:
vii vii
Quality (Paediatric only request: Preclinical (Paediatric only request: Clinical (Paediatric only request: Pharmacokinetics Statistics Safety / Efficacy
) ) vii )
Significant benefit (related to Orphan Drug status) Please briefly outline the scope/content of your questions: Comments: Important: please send this form in Word format as it is to: scientificadvice@emea.europa.eu Do not convert it into PDF.
i
At the time of submission of the SA/PA request the following documents have to be provided: Questions and company’s position (Word format) Detailed table of contents Background information, e.g.: Product Profile Investigators’ Brochure Relevant study protocols or draft study protocols or study outlines Bibliographical data (references) Content of previous scientific advice received Relevant guidelines (other than CHMP Guidance documents) Contract agreement if the request is submitted by a consultant/CRO on behalf of the company
ii Please note that EMEA fees are payable net of all bank charges, withholding taxes and any other deduction
imposed on the customer by legislation of the country of residence.. Only the Applicant will be invoiced, but the invoice can be sent to a different address. If a consultant is dealing with the Scientific Advice request on behalf of the Applicant, nevertheless the payment will be claimed to the Applicant. If purchase order is not yet available at this stage, it will have to be provided at the time of submission of the Scientific Advice request.
iii
Please note that meeting will not take place during CHMP & SAWP meeting dates
iv
If the applicant is applying for protocol assistance, at the time of submission please provide the fee waiver confirmation document from the EMEA Orphan Drug office. Failure to do so will incur a validation of the request as Scientific Advice and an invoice of the full amount will be sent by our account department.
v
If the applicant has an SME status, at the time of submission please provide the fee waiver confirmation document from the EMEA SME office. Failure to do so will incur a validation of the request without SME fee reduction and an invoice of the full amount will be sent by our account department.
vi
Regulatory topics may be addressed at pre-submission meetings or in writing separately from the Scientific Advice request.
vii
Please tick if the questions only relate to Paediatric development.