<insert date DD Month 20YY>

< insert Doc ref ID> Corr1

Pharmacovigilance Risk Assessment Committee (PRAC)

Signal assessment report on <adverse event/reaction>

with <INN(s)>2
EPITT no:<xxx>
Procedure no: <SDA xxx>3

General guidance
Send this report to [email protected] using as e-mail
message subject the following format: Signal AR on <adverse
event/reaction> with INN(s)2 - EPITT <number> - SDA <number>3. Copy the
EMA signal management team ([email protected]).

All validated signals (confirmed or not) should continue to be entered

into the European Pharmacovigilance Issues Tracking Tool (EPITT). This
AR should only be used for confirmed signals. Signals concerning safety
topics that are being addressed within another ongoing parallel
procedure, e.g. PSURs or variation, should in principle not be
confirmed; this should be investigated before a decision on
confirmation is made. For non-confirmed signals, a justification should
be provided in EPITT.

This template should be used throughout all stages from signal

confirmation until adoption of PRAC recommendation(s). It will
therefore be completed by different stakeholders, as specified below:
- Timetable and administrative information: whoever drafts the AR as
relevant information becomes available.

1
Paragraph 2 of the general guidance provided on page 1 was amended on 20 October 2022.
2
In case there are several products authorised for the same active substance and the signal applies only to a specific
product, please add the product name in brackets. For product classes, please only state the class and list the relevant
active substances in the administrative information table.
3
An SDA number will only be available for CAPs, after the PRAC has requested the submission of additional data from an
MAH. It needs to be updated in case of further requests for additional data.

Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands

Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us
Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 An agency of the European Union

© European Medicines Agency, 2022. Reproduction is authorised provided the source is acknowledged.
- Background and initial evidence: whoever confirms the signal
- Additional evidence: PRAC Rapporteur appointed for the signal
- Adopted PRAC recommendation(s): EMA
If the PRAC recommends that the signal follow-up is to be handled
within another procedure such as periodic safety update report (PSUR),
referral, etc., the relevant template for these procedures should be
used at that point.
In case data have been requested from a marketing authorisation holder
(MAH), the assessment report will be shared with them after appropriate
redaction by the EMA.

Confirmation assessment report DD Month YYYY

Adoption of <first> PRAC recommendation DD Month YYYY

<Preliminary assessment report on additional data> 4 <DD Month YYYY>

<Deadline for comments>4 <DD Month YYYY>

<Updated rapporteur assessment report>4 <DD Month YYYY>

<Adoption of <second> PRAC recommendation> 4 <DD Month YYYY>

4
Please delete or repeat as applicable

Signal assessment report on <adverse event/reaction> with <INN(s)>Signal

assessment report on <adverse event/reaction> with <INN(s)>
EMA/PRAC/83037/2014EMA/PRAC/83037/2014 Page 2/8
Administrative information

Active substance(s) (invented name)2 <Text>

Strength(s) <Text> [Only if relevant to the signal]
Pharmaceutical form(s) <Text> [Only if relevant to the signal]
Route(s) of administration <Text> [Only if relevant to the signal]
Indication(s) <Text> [Only if relevant to the signal]
Marketing authorisation holder(s) <Name(s)>
Authorisation procedure [Tick the appropriate box(es) below.]
Centralised
Mutual recognition or decentralised
National

Adverse event/reaction:5

Signal validated by: <Member State>/<EMA>

Date of circulation of signal validation DD Month YYYY
report:
Signal confirmed by: <Member State>/<EMA>
Date of confirmation: DD Month YYYY
PRAC Rapporteur appointed for the <PRAC member's name (Member State)>
assessment of the signal: <E-mail address>
Assessor(s): <Name>
<E-mail address>
Rapporteur’s contact person: <Name>
<E-mail address>
EMA signal management team member: <Name>
<E-mail address>

Declarations
The assessor confirms that this assessment does not include any commercially confidential
information (e.g. ASMF, reference to on-going assessments or development plans etc), non-public
information shared by other competent authorities or organisations, irrespective from which entity was
received*, or reference to pharmacovigilance inspections.

*If the entity from which commercial confidential information and/or non-public information originates
has consented to its further disclosure, the box should be ticked and there would be no need to add
details below.

Whenever the above box is un-ticked please indicate the section and page where the confidential
information is located here:

Confidential information:

5
Please use MedDRA terminology whenever possible

Signal assessment report on <adverse event/reaction> with <INN(s)>Signal

assessment report on <adverse event/reaction> with <INN(s)>
EMA/PRAC/83037/2014EMA/PRAC/83037/2014 Page 3/8
Table of contents
Administrative information...........................................................................................3

1. Background.............................................................................................5
2. Initial evidence.......................................................................................5
2.1. Signal validation...................................................................................................5
2.2. Signal confirmation...............................................................................................5
2.3. Proposed recommendation.....................................................................................5
2.4. Adopted PRAC recommendation.............................................................................6

3. Additional evidence.................................................................................6
3.1. Assessment of additional data................................................................................6
3.2. Rapporteur’s proposed recommendation..................................................................6
3.3. Comments from other PRAC members and MAH(s)...................................................6
3.4. Updated rapporteur's proposed recommendation......................................................7
3.5. Adopted PRAC recommendation.............................................................................7

4. References..............................................................................................7
<Annex>...................................................................................................................8

Signal assessment report on <adverse event/reaction> with <INN(s)>Signal

assessment report on <adverse event/reaction> with <INN(s)>
EMA/PRAC/83037/2014EMA/PRAC/83037/2014 Page 4/8
Background
<Text here.>

[This section should be copied from EPITT by whoever confirms the

signal.]

Initial evidence

1.1. Signal validation

<Text here.>

[This section should be completed at the time of confirmation by

whoever confirms the signal. The signal validation section from EPITT
should be copied into this section. Case narratives may be included
here in full, summarised (e.g. in a table) or provided in an Annex, as
appropriate.]

1.2. Signal confirmation

<Text here.>

[This section should be completed by whoever confirms the signal. It

should provide a critical discussion of the strengths and limitations
of the available evidence supporting the signal validation. Any
additional information available at the time of confirmation and not
considered during validation may be presented.]

1.3. Proposed recommendation

<Text here.>

[This section should be completed by whoever confirms the signal. It

should include details of the proposed actions, e.g. request for
supplementary information, changes to the summary of product
characteristics (SmPC) and/or package leaflet (PL), additional
communication (e.g. direct healthcare professional communication -
DHPC), etc. A brief rationale should be included. Timelines for e.g.
submission and assessment of additional data, submission of variation,
etc., should be specified. If changes to the SmPC and/or PL are
proposed, please provide the exact wording (new text underlined, text
to be removed struck-through).]

Signal assessment report on <adverse event/reaction> with <INN(s)>Signal

assessment report on <adverse event/reaction> with <INN(s)>
EMA/PRAC/83037/2014EMA/PRAC/83037/2014 Page 5/8
1.4. Adopted PRAC recommendation

<Text here.>

[This section should be completed by the EMA signal management team

member. The exact text of the adopted PRAC recommendation should be
included.]

Additional evidence
[This section only applies when the PRAC recommends gathering
additional evidence after initial discussion on the signal for
assessment within the signal procedure. The following sub sections may
be repeated if there is more than one round of assessment. If the PRAC
recommends that the signal follow-up is to be handled within another
procedure such as periodic safety update report (PSUR), referral, etc.,
the relevant template for these procedures should be used at that
point.]

1.5. Assessment of additional data

<Text here.>

[This section should be completed by the PRAC Rapporteur appointed for

the assessment of the signal. It should provide an appraisal of all the
evidence gathered e.g. MAH responses, results of non-urgent information
(NUI), additional analyses carried out by regulators or other
stakeholders (e.g. studies in The Health Improvement Network - THIN,
Clinical Practice Research Datalink – CPRD - or EudraVigilance).]

1.6. Rapporteur’s proposed recommendation

<Text here.>

[This section should be completed by the PRAC Rapporteur appointed for

the assessment of the signal. It should specify whether further actions
are warranted and the rationale behind them. Details of any proposed
actions, e.g. (follow-on) request for supplementary information,
changes to the SmPC and/or PL, additional communication (e.g. DHPC),
etc., should be presented. Timelines for e.g. submission and assessment
of additional data, submission of variation, etc., should be specified.
If changes to the SmPC and/or PL are proposed, please provide the exact
wording (new text underlined, text to be removed struck-through).]

1.7. Comments from other PRAC members and MAH(s)

<Text here (if applicable).>

Signal assessment report on <adverse event/reaction> with <INN(s)>Signal

assessment report on <adverse event/reaction> with <INN(s)>
EMA/PRAC/83037/2014EMA/PRAC/83037/2014 Page 6/8
[This section should discuss comments received. If no comment was
received, please write “No comment received”.]

1.8. Updated rapporteur's proposed recommendation

<Text here (if applicable).>

[This section should provide an updated proposed recommendation,

following comments received from PRAC members and MAH(s), when
applicable, including rationale, details of proposed actions and
timelines.]

1.9. Adopted PRAC recommendation

<Text here.>

[This section should be completed by the EMA signal management team

member. The exact text of the adopted PRAC recommendation should be
included.]

References
<Text here.>

[A consistent style for references and citations should be used

throughout the report. When referencing electronic publications, the
date on which the publication was accessed should be shown after the
web address. The Agency's standard style for citing (in the body of the
report) and referencing (the full source in a list) is illustrated
below:
The effect of magnesium in myocardial infarctions has been reviewed
(Woods, 1991 [1]). Ten years later, a number of recommendations were
made to prevent the injection of vinca alkaloids by the intrathecal
route (Woods, 2001 [2]).
1. Woods, K.L., 'Possible pharmacological actions of magnesium in acute
myocardial infarction', Br J Clin Pharmac, 32, 1991, pp. 3–10.
2. Woods, K, 'The prevention of intrathecal medication errors: a report
to the Chief Medical Officer', London, Department of Health, 2001
[cited 11 May 2009]. Available from:
http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/Publicat
ionsPolicyAndGuidance/DH_4065044 [Accessed 11 May 2009].
Specific referencing software may be used, if available.]

Signal assessment report on <adverse event/reaction> with <INN(s)>Signal

assessment report on <adverse event/reaction> with <INN(s)>
EMA/PRAC/83037/2014EMA/PRAC/83037/2014 Page 7/8
<Annex>

Signal assessment report on <adverse event/reaction> with <INN(s)>Signal

assessment report on <adverse event/reaction> with <INN(s)>
EMA/PRAC/83037/2014EMA/PRAC/83037/2014 Page 8/8