European Medicines Agency

Standard Operating Procedure

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Title: Scientific Advice and Protocol Assistance procedure
PUBLIC
Document no.: SOP/H/3037
Lead Author Approver
Effective Date: 01-JUL-08
Name: Kristina Larsson Name: Agns Saint Raymond
Review Date: 01-JUL-11
Signature: On file Signature: On file
Supersedes:
SOP/H/3037 (15-JUN-02)
Date: 25-JUN-08 Date: 26-JUN-08
TrackWise record no.:1826
1. Purpose
This SOP describes the procedure for taking a request for scientific advice or protocol assistance from
request to a final answer to the applicant.
2. Scope
This SOP applies to the scientific advice section in the Scientific Advice Orphan Drugs Sector and to
applicants for scientifc advice/protocol assistance.
3. Responsibilities
It is the responsibility of each Head of Sector to ensure that this procedure is adhered to within their
own sector. The responsibility for the execution of a particular part of this procedure is identified in
the right-hand column of the table in section 9. Procedure.
4. Changes since last revision
Extensive revision to rewrite SOP.
5. Documents needed for this SOP
Template 1: form for letter of intent for request of Scientific Advice (SA) / Protocol Assistance (PA)
(located at:
http://www.emea.europa.eu/pdfs/human/sciadvice/Template_applicant_letter_%20intent_
submission.doc)
Template 2: Acknowledgement of receipt of Letter of Intent (no presubmission meeting) (located at
X:\Templates\Others\H Scientific advice)
Template 3: Acknowledgement of receipt of Letter of Intent (with presubmission meeting) (located at
X:\Templates\Others\H Scientific advice)
6. Related documents
WIN/H/3035: Organisation of Scientific Advice and Protocol Assistance Pre-submission Meetings
WIN/H/3036: General dealings between SAWP Secretariat and working parties, SAGs, committees
and patients organisations
WIN/H/3039: Validation of scientific advice/protocol assistance request
WIN/H/3040: Use of scientific advice and protocol assistance database
WIN/H/3041: Scientific Advice and Protocol Assistance Master File
WIN/H/3042: Organisation of discussion meetings for Scientific Advice and Protocol Assistance
WIN/H/3073: Check of experts for scientific advice/protocol assistance
WIN/H/3139: Scientific Advice/Protocol Assistance Peer Review
WIN/H/3195: Organisation of Scientific Advice Working Party meetings
WIN/H/3196: Finalisation of Scientific Advice and Protocol Assistance letters

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WIN/H/3197: Nomination of Coordinators for Scientific Advice and Protocol Assistance
WIN/H/3248: Scientifc Advice and Protocol Assistance post advice procedure
7. Definitions
AA Assistant Administrator
COMP Committee for Orphan Medicinal Products
DM Discussion Meeting
FAL Final Advice Letter
LoI Letter of intent
PDCO Paediatic Committee
SAA Scientific Advice Administrator
SAG Scientific Advisory Group
SAWP Scientifc Advice Working Party
Sec Secretary
TOD Table of Decisions
WP Working Party of the Committee for Medicinal Products for Human Use

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8. Process Map(s)/ Flow Chart(s)
2.Retrieve LoI from Inbox
5. Has a presubmission
meeting been requested?
10. Nominate coordinators
(WIN/H/3197 &
WIN/H/3195)
Inform applicant
9. Send timelines
to applicant
11. Check assessment
team conflicts of interest
(WIN/H/3073 &
WIN/H/3195)
12. Will presubmission
meeting take place?
13. Hold
presubmission meeting
(WIN/H/3035)
14. Send initial draft
dossier
16. Validate dossier
(WIN/H/3039)
17. Enter in database
(WIN/H/3040)
18. Prepare SAWP
agenda (WIN/H/3195 &
WIN/H/3040)
19. Send final dossier
20. Validate final dossier
(WIN/H/3039)
22. Involve WPs/SAGs/
PDCO & patient
representative
(WIN/H/3036)
23. Send 1
st
report to
SAWP secretariat
25. Hold 1
st
reports meeting
and discuss agenda
26. Hold teleconference
with Chairperson
28. Prepare Table of
Decisions (WIN/H/3195 &
WIN/H/3196)
29. Update database
(WIN/H/3040)
YES
NO
YES
NO
SAWP
Day +30
SAWP
Day 0
START
SAWP
Day 60 (for
presubmission)
or
Day 30 (no
presubmision)
6. Organize presubmission
meeting (WIN/H/3035)
27. Inform applicant of the
outcome of the meeting
30. Is discussion
meeting required?
32. WP/SAG/PDCO
sends comments to
SAWP secretariat
34. Prepare and send
joint reports to SAWP
secretariat
31. Organise and hold
discussion meeting
(WIN/H/3042)
SAWP
Day +60
37. Has the
applicant raised
post-advice
issue?
38. Go to WIN/H/3248
YES
NO
END
35. Conduct peer review
(WIN/H/3139)
8. Distribute products
15. Save dossier in EDMS
Send link to SAA
1. Send LoI
7. Send folder
link/create request for
coordinators
(WIN/H/3197)
21. Save and file final
dossier (WIN/H/3039 &
WIN/H/3041)
24. Save 1
st
report
33. Save WP comments
4. Send acknowledgement
of receipt to applicant
3. Update tracking table
36. Prepare FAL
(WIN/H/3196)
YES
NO



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9. Procedure
The organisation of the SAWP meeting runs in parallel with this procedure. Refer to WIN/H/3195 for
details.

Step Action Responsibility
1 Send LoI (template 1) by email to the scientific advice inbox
(Scientificadvice@emea.europa.eu) indicating whether or not a pre-
submission meeting is required.
Submission deadlines and SAWP meeting dates are available at:
http://www.emea.europa.eu/pdfs/human/sciadvice/36814606en.pdf
This step can be preceded by communications with EMEA (e.g.
phone, E-mails). Details can also be found on the webpage:
http://www.emea.europa.eu/htms/human/sciadvice/Scientific.htm
Applicant

2 Retrieve LoI from inbox.
Create a new folder in EDMS for the product and save the LoI.
Sec
3
Include relevant information in Excel tracking table and update table
as and when necessary.
Sec
4
Send acknowledgment of receipt by E-mail to applicant within 2
working days after the deadline for receiving LoIs (template 2 or 3).
Sec
5 Has a presubmission meeting been requested?
If yes, go to step 6.
If not, go to step 7.
Sec
6 Organise presubmission meeting (see WIN/H/3035). Sec
7 Send the link to the folder for the new product to the SAA
responsible for the secretariat.
Create the list of nominations of coordinators (see WIN/H/3197).
Sec

Sec/SAA
8 Distribute the new products between the SAAs. SAA
9 Send the timelines to the applicant. Sec
10 Nominate the coordinators at the SAWP meeting and inform the
applicant of the appointed coordinators (see WIN/H/3197 and
WIN/H/3195)
SAA
Sec
11 Check appointed assessment teams for conflict of interest (see
WIN/H/3073 and WIN/H/3195).
Sec/SAA
12 Will a presubmission meeting take place?
If yes, go to step 13.
If not, go to step 14.
Sec
13 Hold presubmission meeting (see WIN/H/3035). Sec
14 Send initial draft dossier by email (Eudralink) to the scientifc advice
inbox (Scientificadvice@emea.europa.eu).
Applicant

15 Save initial draft dossier in EDMS in the product folder.
Send the link to the draft dossier to the appointed SAA for validation.
Sec
16 Validate the initial dossier (see WIN/H/3039). SAA/AA
17 Enter the information on the products in the database (see
WIN/H/3040).
AA/Sec
18 Prepare the SAWP meeting agenda (see WIN/H/3195 and
WIN/H/3040).
AA

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Step Action Responsibility
19 Send final dossier as paper copy and CDs to the EMEA by courier. Applicant
20 Validate final dossier (see WIN/H/3039). SAA
21 Save and file the final dossier (see WIN/H/3039 and WIN/H/3041). Sec
22 Involve identified WPs/SAGs/PDCO and patients organisations (see
WIN/H/3036).
Sec
23 Send 1
st
reports to the SAWP secretariat inbox. Coordinators
24 Save 1
st
reports in EDMS in the product folder. Sec
25 Hold meeting to discuss 1
st
reports if deemed necessary. SAA
26 Hold briefing telephone conference with the chairperson and vice-
chairperson of SAWP.
Discuss the important issues and discrepancies in the reports and
bring up special points on the agenda if applicable.
SAA
27 Inform the applicant (by phone or email) of the outcome of the
SAWP meeting, i.e. if the applicant will be invited to a DM or not.
SAA
28 Prepare the TOD (see WIN/H/3195 and WIN/H/3196). AA
29 Update the database (see WIN/H/3040). AA
30 Is DM required?
If yes, go to step 31.
If no, go to step 32.

31 Organise and hold DM (see WIN/H/3042).
32 Send comments on 1
st
reports to SAWP secretariat inbox (see
WIN/H/3036).
WP/SAG/PDCO
33 Save comments in EDMS product folder. Sec
34
Prepare and send joint reports to SAWP secretariat mailbox by
deadline specified in ToD.
Coordinators
35 Conduct peer review (see WIN/H/3139). SAA/Sec
36 Prepare FAL for sign off (see WIN/H/3196).
Note: If protocol assistance also for COMP Chair.
Coordinators/Sec/
SAA/AA/CHMP/
COMP
37 Has the applicant raised post-advice issues?
If yes, go to step 38.
If no, END of procedure.

38 Go to WIN/H/3248 Sec/SAA

10. Records
All paper and electronic records generated during the procedure are filed as described in WIN/H/3041.