Standard operating procedure

Title: Preparation of question-and-answer documents for withdrawals of marketing authorisation

applications by the Medical Information Sector

Status: PUBLIC Document no.: SOP/H/3137

Lead author Approver Effective date: 21-MAR-12
Name: Juan Garcia Burgos Name: Noël Wathion Review date: 21-MAR-15
Signature: ON FILE Signature: ON FILE Supersedes:
SOP/H/3137 (28-NOV-07)
Date: 20-MAR-12 Date: 21-MAR-12 TrackWise record no.: 2917

1. Purpose
The purpose of this SOP is to describe the process for preparing question-and answer documents
(q-and-a) following the withdrawal of an application for marketing authorisation (MAA), an application
for a line extension linked ton extension of indication or an application for a Type II variation for an
extension of indication for human medicines.

2. Scope
This SOP applies to the Safety and Efficacy of Medicines (H-SE) and Quality of Medicines (H-QM)
sectors in the Human Medicines Development and Evaluation (H) unit and to the Regulatory,
Procedural and Committee Support (P-R) and Medical Information (P-MI) sectors in the Patient Health
Protection (P) unit.

3. Responsibilities
It is the responsibility of each Section Head, Head of Sector and Head of Unit to ensure that this
procedure is adhered to within their own section/sector/unit. The responsibility for the execution of
each step is identified under 9. Procedures.

4. Changes since last revision

Update to reflect the new organisational names in the Agency.

7 Westferry Circus ● Canary Wharf ● London E14 4HB ● United Kingdom

Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8416
E-mail info@ema.europa.eu Website www.ema.europa.eu An agency of the European Union

© European Medicines Agency, 2012. Reproduction is authorised provided the source is acknowledged.
5. Documents needed for this SOP
Template 1: letter of withdrawal of application (for applicant)

See X:\Templates\Filenew\H-AR-LoQ-LoOI-SmOP

Template 2: q-and-a on withdrawal of application (initial)

Template 3: q-and-a on withdrawal of application (extension of indication, line extension)

See X:\Templates\Others\H – Q and A documents

6. Related documents
 Reflection Paper on Publication of Withdrawals of Marketing Authorisation Applications for Human
Medicinal Products (EMA/239350/2005)
http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2
009/10/WC500005061.pdf)

 SOP/H/3224 - Preparation of a European Public Assessment (EPAR) following a withdrawal of

application

 Guidance on the Handling of EPAR files Human Products (EMA/447123/2006 – working document)

7. Definitions
AR Assessment report

CdT Centre de Traduction (Translation Centre of the EU Institutions)

MAH Marketing Authorisation Holder

MedW Medical Writer

P-MI Medical Information Sector

PTL Product Team Leader

PTM Product Team Member

q-and-a Question-and-answer document

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SOP/H/3137, 21-MAR-12 Page 2/8
8. Process map(s)/ flow chart(s)

START

1. Receive information
about potential withdrawal
of application

2. Provide Applicant with

template letter for
withdrawal

3. Inform P-MI and Press

Office

4. Letter of
no
withdrawal of
END
application
received?

yes

5. Circulate letter of
withdrawal and relevant
info

6. Letter yes 6.1. Agree timelines with

received
PTL for circulation +
during the
finalisation of q-and-a
week before
document
CHMP?

no

7. Create Draft I q-and-a

document and send out for
review

8. yes
8.1 Amend Draft I q-and-a
Comments
document accordingly
received?

no

9. Send Draft I q-and-a

document to PTL

10. Circulate Draft I

q-and-a to (Co)-
Rapporteur for review

Continue with Step 11.

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 Continue from Step 10.

11. Forward comments/no

comments to Med Writer

12. Finalise Draft

document and save as
Draft II q-and-a

13. Circulate Draft II

q-and-a to Applicant for
information

14. Forward comments/no

comments to Med Writer

15. Finalise Draft II q-and-

a document

16. Circulate Final q-and-a

to CHMP

17. Publication of q-and-a

document

18. Withdrawal of
application to be noted in
CHMP monthly report

19. Arrange for translation

of q-and-a documents

no 20.1 Publication of
20. CHMP AR
translation of q-and-a
available?
documents

yes

21. Publication of
translations of q-and-a
documents + public AR

22. File all documents

END

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SOP/H/3137, 21-MAR-12 Page 4/8
9. Procedure
Step Action Responsibility

1. PTL receives information about potential withdrawal of PTL

application

PTL is informed by the Applicant/MAH of a possible withdrawal of

application.

2. PTL ensures that Applicant uses the appropriate template for the PTL
letter of withdrawal (template 1).

3. PTL informs P-MI and the Press Office as soon as possible directly PTL
by e-mail.

4. Letter of withdrawal received? PTL

 If the letter of withdrawal is received go to step 5.

 If the letter of withdrawal is not received the process ends.

5. Circulate letter of withdrawal and relevant info PTL

PTL to circulate:

 the letter of withdrawal to P-MI and Press Office;

 the latest adopted CHMP assessment report, if available (after

Day 120 for initial applications/line extensions and after Day 90
for extension of indication), and the latest available product
information to P-MI

6. Has the letter of withdrawal been received the week before PTL
CHMP?

 If the letter of withdrawal is received the week before the

CHMP, go to step 6.1.

 If the letter of withdrawal is received at any other time, go to

step 7.

6.1 Agree timelines with PTL MedW

If the letter of withdrawal is received the week before CHMP, fast

timelines need to be agreed with the PTL for circulation and
finalisation of the q-and-a by the following Thursday (last day of
CHMP).

7. Create Draft I q-and-a document and send it for internal MedW

review

The MedW write the Draft I q-and-a using template 2 or template

3, as appropriate. The MedW sends a link to the Draft I q-and-a to
P-MI, PTL/PTM and Press Office, asking for feedback within 2
working days.

8. Have any comments been received? MedW

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 Step Action Responsibility

 If any comments have been received go to step 8.1.

 If no comments have been received go to step 9.

8.1 Amend Draft I q-and-a document accordingly MedW

Finalise Draft I q-and-a document by incorporating any comments

received within one working day.

9. Send Draft I q-and-a document to PTL MedW

MedW sends the Draft I q-and-a document to PTL ready for review
by rapporteur(s).

10. Circulate Draft I q-and-a document for review to PTL

Rapporteur/Co-Rapporteurs

PTL will send the Draft I q-and-a document to the Rapp and Co-
Rapp for brief consultation phase. Comments are to be received no
later than Friday before CHMP week.

Note: this step may be delegated by PTL to MedW if appropriate

(e.g. tight timelines). In such case, the PTL provides the MedW
with the contact names and step 11 is not needed.

11. Forward comments from Rapporteur/Co-Rapporteur PTL

If comments/no comments are received from Rapporteur/Co-

Rapporteur these are forwarded by the PTL to MedW in MIS so that
they can be taken into account and incorporated as appropriate.

12. Finalise Draft I q-and-a document MedW

On receipt of comments from Rapp/Co-Rapp, the MedW finalises

Draft document and saves it as Draft II q-and-a forwards it back to
PTL.

13. Circulate Draft II q-and-a document for information to PTL

Applicant/MAH

PTL circulates the Draft II q-and-a for comments to the

Applicant/MAH, no later than Monday of the CHMP. Comments
should be received within 24 hours.

14. Forward feedback to Medical Writer PTL

If comments/no comments are received from Applicant/MAH these

are forwarded by the PTL to MedW in P-MI so that they can be
taken into account and incorporated as appropriate.

15. Finalise Draft II q-and-a document MedW

Incorporate any relevant comments from the Applicant/MAH, as

appropriate, to create the final q-and-a document for publication
and forward it back to PTL.

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 Step Action Responsibility

16. Circulate final q-and-a document to CHMP for information PTL

PTL tables the final q-and-a to the CHMP for information during
CHMP meeting.

17. Publication of the q-and-a document (EN version) PTL Secretary

The withdrawal letter from the Applicant and the q-and-a document
(EN version) are published on the EMA website in time for the
CHMP monthly report, i.e. Tuesday after CHMP at the latest.

The letter of withdrawal should have all personal data blanked out
(deletion of names and personal e-mail/phone for company
signatory(ies) and EMA staff).

18. Reference the withdrawal of the application within the CHMP Secretariat
CHMP monthly report.

The CHMP monthly report will reflect the withdrawal, along the
same lines as the initial press-release. The report will make
reference to the published q-and-a.

19. Translation of q-and-a document PTL Secretary

The PTL secretary is responsible for requesting from V-PD-DIS the

translations of the q-and-a document (EN version) into all EU
languages by the CdT.

20. Is the CHMP assessment report available (after Day 120 for PTL Secretary
initial applications/line extensions and after Day 90 for
extension of indication)?

 If the CHMP AR is not available, go to step 20.1.

 If the CHMP AR is available, go to step 21.

20.1. Publication of translations of q-and-a document if CHMP AR PTL Secretary

is not available

PTL secretary to publish the translations of the q-and-a as soon as

received from the CdT.

21. Publication of translations of q-and-a if CHMP AR is PTL Secretary

available

PTL secretary to publish the translations of the q-and-a document

at the same time as the Application withdrawal assessment report
(prepared according to SOP H/3224).

22. File all documents PTL Secretary

PTL secretary to file all the documents.

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10. Records
Withdrawal q-and-a and all correspondence relating to them are part of the Master File and should be
kept according to SOP/PDM/1004.

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