Veterinary Medicine and Product Data Management
Rapporteur's assessment report
Complete PSUR for
Medicinal product for veterinary use
<PRODUCT NAME>
Active substance(s)/international non-proprietary name(s):
<insert INN>
Marketing authorisation holder(s):
<NAME>
Authorisation type:
Community (Central)
MA number(s):
<INSERT NUMBER>
Time period covered in the PSUR:
<DD-MM-YYYY - DD-MM-YYYY>
Rapporteur:
<Name>
<Date of assessment report [day – month – year]>
<Attachment: Latest approved Summary of Product Characteristics>
7 Westferry Circus ● Canary Wharf ● London E14 4HB ● United Kingdom
Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8447
E-mail info@ema.europa.eu Website www.ema.europa.eu
An agency of the European Union
1. Data review
[Very brief and conclusive overall summary of available reports or
statement of their absence. Detailed summary descriptions of specific
parts of the data would only be introduced in support of questions or
comments to the MAH on the data, or to support conclusions for
recommended actions. N.B. Lack of expected efficacy is defined
according to recommended use of the product. Concerning Tables, please
follow instructions in Annex]
1.1. Adverse events in target species
[including events of lack of expected efficacy and those events
occurring after off-label use in target species]
1.1.1. After recommended use
1.1.2. After non-recommended use
[off-label, including overdose]
1.2. Adverse events in humans
1.3. Other pharmacovigilance fields
1.3.1. Adverse events in non-target species
1.3.2. Potential environmental problems
1.3.3. Investigations of the validity of withdrawal periods
1.3.4. Transmission of infectious agents
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1.4. Non-spontaneous reports
[overview of available data from other sources e.g. pre-authorisation
studies, post authorisation safety studies, published adverse event
reports]
1.5. Other information
[Adverse events arising from prescription errors or medication errors,
including those due to invented names of veterinary medicinal products
(VMPs) or similar appearance (e.g. mix-up with another VMP)]
1.6. Exposure
[i.e. No. of animals treated based on ‘standard’ use of the product.
Where applicable, by presentation, target species or categories (e.g.
cattle and calves); Refer to Volume 9B (when available) for
standardised bodyweights]
1.7. Incidence
[1) Crude world-wide ratio (number of animals:number of doses) (A, B or
O, including O1, N);
2) Incidence. Mainly, it is important that there is consistency in the
approach to incidence calculation between PSURs for the product in
question.
N.B. consider if there is an unusually high proportional number of
reports coded as unlikely related (N) or unassessable (O) as it may
indicate a signal or a systematic bias]
2. Evaluation of the adverse reactions in view of the
warnings included in the SPC
[Consider also any increases in incidence relative to previous PSURs
and comment on assessment of MAH’s benefit-risk evaluation].
<There is <no> concern to be addressed via amendment of the product literature regarding>

evidence of previously unidentified toxicity or safety concerns,

<a> change in frequency of known toxicity or expected undesirable effects,

evidence of veterinary medicinal product (VMP) interactions,

evidence of new undesirable effects associated with off-label use, including aspects of overdose
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
evidence of clinical human symptoms associated with the use of the product,

evidence of lack of expected efficacy,
[See Volume 6C
http://ec.europa.eu/health/documents/eudralex/vol-6/index_en.htm]>
and therefore the following sections of the SPC need to be amended as follows:
3. Overall conclusion
<As no adverse effect was observed so far, there are no changes to the evaluation of the benefits and
risks afforded by the product.
The MAH has concluded that the benefit-risk balance <remains unchanged, has changed> and that
<the following, no> actions are necessary: <insert actions>
The conclusion of this assessment is <not> in agreement with the conclusion of the MAH <and actions
are recommended as listed below>. <e.g. amendments to the SPC (as detailed in Section 2), advice is
requested from the PhVWP-V, other [to be specified] >
4. Questions or comments to be addressed to the MAH
[If there are questions or comments for the MAH to address prior to
finalisation of the AR, the draft AR will be forwarded with the request
to the MAH]
<There are no questions/comments to be addressed to the MAH.>
5. Recommended action
[Consider if there is a need for action e.g. amendments to the SPC (as
detailed previously in Section 2), recommendations to MAH in view of
preparations of future PSURs, other action (please specify)]
<No changes to the product literature or other regulatory actions are necessary.>
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Annex: table(s) [delete annex if no tables are needed for this PSUR
Assessment Report]
[This section includes templates for tables for use if necessary. The
table templates below are included as examples for those situations
when the assessor feels some of the MAH data from the PSUR needs to be
presented in the assessment report.
Data should be presented only when it is necessary to explain or
clarify an issue that is likely to lead to a question or recommendation
to the MAH or would require some other specific action. In such
circumstances any suitable template table should be completed in Annex
and reference to the table(s) included in the text of the assessment
report. The assessor may create other, more suitable tables. Data
should not be routinely presented in the assessment report, but
reference to data in the PSUR should be sufficient in most
circumstances.]
Table 1: Comparison over time of the ratio of animals reported for <SARs, lack of expected efficacy>
during a period to the amount of product sold by period <and by year, if data is available>
Period
PSUR 1
<Year
PSUR 2
Year
Year
Year
Year
Year>
Number of animals <reacting, experiencing lack
of efficacy> during the period
<Number of doses sold during period, sales
volume*> (<insert sort e.g. Litres, Doses>)
Ratio (number of animals : number of doses)
* Sales volume only where it is not feasible to estimate the number of doses. Every attempt should be
made to estimate the doses sold.
Table 2: Sales volume, estimated number of treated animals, number of animals reacting (animal
count) and incidence of suspected adverse reactions during the reporting period by country and region
Country*
Total sales
Number of
Number of
volume
animals treated
animals reacted
**
in SARs assessed
Incidence***
A, B or O
Austria
Belgium
Bulgaria
Cyprus
Czech Republic
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Ireland
Italy
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Country*
Total sales
Number of
Number of
volume
animals treated
animals reacted
**
in SARs assessed
Incidence***
A, B or O
Latvia
Lithuania
Luxembourg
Malta
Netherlands
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Iceland
Liechtenstein
Norway
Total EU/EEA
Third countries
Total
* This table includes details only on those countries of the EU/EEA where the product has
been sold during the reporting period. Countries with zero (0) sales have been deleted.
** <please explain here assumptions underlying the estimated number of treated animals >
*** <please explain here the assumptions underlying the incidence calculation– see also
Volume 9 of the Rules governing medicinal products in the European Union, Part II. 1.
Pharmacovigilance of Veterinary Medicinal Products (to be replaced by Volume 9B, when
available)>
Table 3: Report, animal and mortality count for all reports received on any suspected adverse reaction
during the reporting period in any species, including human beings. All causality categories (A,B,O,N)
are included.
Reports
Community (EU/EEA)
Third Countries (Non EU/EEA)
Reports
Number of reported
Deaths
Reports
Number of reported
Deaths
(N)
animals (N)
(N)
(N)
animals (N)
(N)
Target
species
Non-target
species
Human
Total
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Table 4. Report count of serious and non-serious suspected adverse reactions reports received during
the period. All causality categories (A, B, O, N) are included. This table excludes reports of lack of
expected efficacy
Use of product
Category of species
As recommended in
<Insert Target
SPC
species>
Off label use
<Insert Target
Number of reports
Serious
Non-serious
Total
species>
<Insert Non-Target
species.
Unknown
<Insert Target
species>
Total
All
Table 5: Number of animals affected and nature of reports by causality category in <non->target
species received during the reporting period (animal count)
Reports
A (probable) + B (possible) +
N (unlikely)
O (unclassifiable)
Number of reported
Deaths
Number of reported
Deaths
animals (N)
(N)
animals (N)
(N)
Suspected adverse
reactions
Lack of expected efficacy
Total
Table 6: Number and nature of suspected adverse reactions in any species received during the PSUR
period (report, animal and mortality count)
Reports
Community (EU/EEA)
Third Countries (Non EU/EEA)
Reports
Number of
Deaths
Reports
Number of
Deaths
(N)
reported
(N)
(N)
reported animals
(N)
animals (N)
(N)
Target species
Used as
recommended
Off label use
Unknown
Non-target species
Total
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Table 7: Event count of clinical signs reported as <Serious, Serious unexpected, Non-serious
unexpected (unlisted)> adverse reactions (animal count) by species and VeDDRA terminology
Species
Clinical sign
Number of events*
VeDDRA terms, <SOC, HLT, PT > level
* Number of times the clinical sign was reported (i.e. occurrences, citations, occasions etc.)
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