Rapporteur’s assessment report

for

Medicinal product for veterinary use

<product name>

Active substance(s)/international non-proprietary name(s):

Marketing authorisation holder(s):

<Name>

Authorisation type:

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]

EMA/151204/2017 / Page 1/4

Abbreviationsand definitions

AE Adverse event

AR Adverse reaction

BW (b.w.)Body weight

CVMP Committee for Medicinal Products for Veterinary Use

EEAEuropean Economic Area

EMAEuropean Medicines Agency

EUEuropean Union

LEELack of expected efficacy

MAH Marketing authorisation holder

OLUOff-label use

PhV Pharmacovigilance

PSUR Periodic safety updates report

QPPV Qualified person for pharmacovigilance

SAE Serious adverse event

SARSerious adverse reaction

SOP Standard operating procedure

PASSPost authorisation safety study

PIProduct information

SPCSummary of product characteristics

VMPVeterinary medicinal product

Causality assessment ABON categories

  • A(probable)
  • B(possible)
  • O1(inconclusive)
  • O(unclassifiable/unassessable)
  • N(unlikely to be product related)

1. Data review

Rapporteur to insert text

[Very brief and conclusive overall summaryof 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 II]

1.1. Adverse events in target species

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[including events of lack of expected efficacy and those events occurring after off-label use in target species]

1.1.1. After recommended use

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1.1.2. After non-recommended use

(off-label, including overdose)

Rapporteur to insert text

1.2. Adverse events in humans

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1.3. Other pharmacovigilance fields

Rapporteur to insert text

1.3.1. Adverse events in non-target species

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1.3.2. Potential environmental problems

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1.3.3. Investigations of the validity of withdrawal periods

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1.3.4. Transmission of infectious agents

Rapporteur to insert text

1.4. Non-spontaneous reports

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[overview of available data from other sources e.g. pre-authorisation studies, post authorisation safety studies, published adverse event reports]

1.5. Other information

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a) [Adverse events arising from prescription errors or medication errors, including those due to invented names of VMPs or similar appearance (e.g. mix-up with another VMP)]

1.6. Exposure

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b) [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

Rapporteur to insert text

[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 PI

[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 VMP interactions,
  • evidence of new undesirable effects associated with off-label use, including aspects of overdose
  • evidence of clinical human symptoms associated with the use of the product,
  • evidence of lack of expected efficacy,

and therefore the following sections of the PIneed to be amended as follows: [See Volume 6C for PIguidelines and Questions and answers on how to express the frequencyof adverse reactions within the product information (EMA/CVMP/150343/2016):

See also guidance on warnings to be placed in relation to resistance:

Revised guideline on the SPC for antimicrobial products

Guideline on the summary of product characteristics for anthelmintic products for sheep, goats, cattle and horses)

Rapporteur to insert text

3. Overall conclusion

[Please include the conclusions on the issues discussed within the report to ensure that the conclusions are supported in the report]
<As no adverse eventswere observed so far, there are no changes to the evaluation of the benefits and risks afforded by the product.

Adverse events observed so far do not indicate the 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 PI (as detailed in Section 2), advice is requested from the PhVWP-V, other [to be specified] >

Rapporteur to insert text

4. Questions or comments to be addressedto/by>the MAH

[If there are questions or comments for the MAH to address prior to finalisation of the AR, please state questions in this part. The draft AR will be forwarded with the questions to the MAH. Recommendations to change the PI should always be preceded by questions to the MAH to provide the opportunity to comment on the proposed changes before a final recommendation is made e.g.

In light of the findings described previously concerning <briefly specify issue e.g. adverse reactionsthe MAH is requested to critically evaluate the potential impact on the benefit-risk balance of the product, taking into account the information available on the <product/active substance> and comment on the need to amend the product information to address this, where necessary proposing appropriate wording

After the evaluation of the MAH’s response to the questions, please update the AR as appropriate using tracked changes.The MAH’s response to the questions can be discussed in this Section of the report (4) or in the other relevant sections of the report according to your preferences and on the number and content of questions raised.

Please include your assessment of the MAHs’ answers and not a copy paste of the response from the MAH

If the questions and answers will be discussed in this part, please discus as proposed bellow:

The MAH was requested to address the following:

include the question(s) here>

include the Rapporteur’s evaluation of the MAH’s response(s) here>.

There are no <more> questions/comments to be addressed to the MAHprior to finalisation of the AR.>

Rapporteur to insert text

5. Recommended action

Rapporteur to insert text

[Consider if there is a need for action e.g. amendments to the PI (as detailed previously in Sections 2-4) or request for a targeted PSUR). Please ensure that any changes to the PI have previously been communicated to the MAH (i.e. in form of questions to MAH) prior to adoption by CVMP]

Consider and specify recommendations for the MAH to address in future PSURs. Ensure that recommendations have been already discussed in the assessment report and are also listed in Section 5 together with a brief explanation in support of the request, so a comprehensive recommendation is included in the CVMP outcome letter to the MAH (N.B. rapporteur’s assessment reports are no longer routinely sent to MAHs, unless SPC updates, or targeted PSUR are requested, or specifically requested by the MAH, public).

It is recommended to amend the product information as follows (additions to text in bold, deletions in strikethrough):

  • [include amendments in line with the QRD template]

<No changes to the product literature or other regulatory actions are necessary.<However for the preparation of future PSURs, the MAH is requested to address the following:

  • include recommendations with brief supporting explanation

In the case of withdrawal or expiry of the marketing authorisation (MA), please consider the following recommendations:

<However, following the withdrawal/expiry of the marketing authorisation, the MAH is encouraged to continue to report any adverse events received after the data lock point of this PSUR electronically i.e. to EudraVigilance Veterinary (EVVet). <No further/Further> PSURs are considered necessary <please specify time-frame if further PSURs are required and brief justification for request>.

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 II 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 < suspected adverse reactions (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 / PSUR 2
<Year / 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 (SARs) during the reporting period by country and region

Country* / Total sales volume / Number of animals treated ** / Number of animals reacted in SARs assessed A, B or O causality / Incidence***
Austria
Belgium
Bulgaria
Croatia
Cyprus
Czech Republic
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Ireland
Italia
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 Community 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 9B of the Rules governing medicinal products in the European Union, Part I. 1. Guidelines for marketing authorisation holders >

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 (N) / Number of reported animals (N) / Deaths (N) / Reports
(N) / Number of reported animals (N) / Deaths (N)
Target species
Non-target species
Human
Total

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 / Number of reports
Serious / Non-serious / Total
As recommended in PI / <Insert Target species>
Off label use / <Insert Target 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) +
O1/O1(inconclusive/unclassifiable) / N (unlikely)
Number of reported animals (n) / Deaths
(n) / Number of reported animals (n) / Deaths
(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 (n) / Number of reported animals (n) / Deaths (n) / Reports (n) / Number of reported animals (n) / Deaths (n)
Target species
Used as recommended
Off label use
Unknown
Non-target species
Total

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
VeDDRA terms, <SOC, HLT, PT > level / Number of events*

* Number of times the clinical sign was reported (i.e. occurrences, citations, occasions)

[Standard terminology and abbreviations to use and avoid – please delete this page after completion of assessment report]

Terminology and abbreviations for use in assessment reports
Please use: / Please avoid using:
Adverse event / Suspected adverse event
Adverse reaction / Adverse drug reaction;
Side-effect
Authorisation [of product] / Licensing
Causality categories:
  • A (probable)
  • B (possible)
  • O1 (inconclusive)
  • O (unclassifiable/unassessable)
  • N (unlikely to be product related)

Clinical signs / Symptoms (when referring to animals)
Incidence / Incidence rate
Marketing authorisation holder (MAH) / Applicant
Lack of expected efficacy (LEE) / Suspected lack of expected efficacy (SLEE) or lack of efficacy
Off-label use / Extra-label
Recommended use / On-label use
Summary of product characteristics (PI) / Label
Suspected adverse reaction (SAR) / -
Veterinary medicinal product (VMP) / Drug
Rapporteur’s assessment report for <product name>
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