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					                               RAPPORTEUR’s



                                   AND



                            CO-RAPPORTEUR’s



  JOINT PRELIMINARY RENEWAL ASSESSMENT REPORT



                                    FOR



                            <INVENTED NAME>

                          <(ACTIVE SUBSTANCE)>



                          EMEA/H/C/{nnnn}/R/{nnnn}




Marketing Authorisation holde r:
Rapporteur:
Co-Rapporteur:
Date of this report:
Deadline for comme nts:



                                                     Renewal AR -2007
                      ADMINISTRATIVE INFORMATION
Invented name of the medicinal
product:
INN (or common name) of the active
substance(s):
Pharmaco-therapeutic group
(ATC Code):
Pharmaceutical      form(s)       and
strength(s):
Marketing Authorisation Holder (s):
Rapporteur:                             Name:
                                        Tel:
                                        Fax:
                                        Email

Rapporteur’s contact person:            Name:
                                        Tel:
                                        Fax:
                                        Email:

Co-Rapporteur:                          Name:
                                        Tel:
                                        Fax:
                                        Email:

EMEA Product Team Leader:               Name:
                                        Tel:
                                        Fax:
                                        Email:
Names of the      assessors    of the   Non Clinical
Rapporteur:                             Name:
                                        Tel:
                                        Fax:
                                        Email:

                                        Safety
                                        Name:
                                        Tel:
                                        Fax:
                                        Email:

                                        Efficacy
                                        Name:
                                        Tel:
                                        Fax:
                                        Email:

                                        Quality
                                        Name:
                                        Tel:
                                        Fax:
                                        Email:


                                                       Renewal AR - rev. 1- 2007
Names of the assessors of the Co-   Non Clinical
Rapporteur:                         Name:
                                    Tel:
                                    Fax:
                                    Email:

                                    Safety
                                    Name:
                                    Tel:
                                    Fax:
                                    Email:

                                    Efficacy
                                    Name:
                                    Tel:
                                    Fax:
                                    Email:

                                    Quality
                                    Name:
                                    Tel:
                                    Fax:
                                    Email:




                                                   Renewal AR - rev. 1- 2007
TABLE OF CONTENTS


I      RECOMMENDATION ..........................................................................................................5

II     SCIENTIFIC DISCUSSION ...................................................................................................5

     II.1     Introduction ....................................................................................................................5

     II.2     Quality ...........................................................................................................................5

     II.3     Non-clinical ....................................................................................................................5

     II.4     Clinical Efficacy and Safety.............................................................................................5

       II.4.1           Clinical Efficacy ..................................................................................................6

       II.4.2           Clinical Safety .....................................................................................................6
            II.4.2.1        Cumulative experience <period> .......................................................................6
            II.4.2.2        Report of Post Marketing Experience <period> ..................................................6
       II.4.2.3         Conclusion on Safety............................................................................................6

     II.5     Product Information ........................................................................................................7

     II.6     Post-approval commitments to be fulfilled by the MAH.....................................................7

     II.7     Conclusions on the Benefit Risk Balance of the product ....................................................8

     II.7     List of outstanding issues.................................................................................................8




                                                                                                            Renewal AR - rev. 1- 2007
I      RECOMMENDATION

Based on the review of the data submitted for this renewal application, the Rapporteur and Co-
Rapporteur recommend the renewal of the Marketing Authorisation for <Invented Name> (<INN> -
EMEA/H/C/XXX/X/XX), <provided that the MAH undertakes to fulfil the conditions <and
obligations> as detailed in this assessment report.>.

<The Rapporteur and Co-Rapporteur are also of the opinion that the renewal can be granted with
unlimited validity.>

<The Rapporteur and Co-Rapporteur are of the opinion that one additional five-year renewal is
required on the basis of pharmacovigilance grounds.>


OR:

Based on the review of the data submitted for this renewal application, the Rapporteur and Co-
Rapporteur consider that the renewal procedure for <Invented Name> (<INN>,
EMEA/H/C/XXX/X/XX) could only be finalised, if satisfactory answers are given to the issues as
detailed in this assessment report (see II.7 ‘List of Outstanding Issues’).




II     SCIENTIFIC DISCUSSION

II.1    INTRODUCTION
[Provide a short introduction on the product and its indications, including a very general overview of
the product usage e.g. where it is approved and how extensive its use is: X was first authorised <in <
> and> in Europe on <DD Month JJJJ>. In the EU, X has been marketed in <A, B, C and D> during
the reporting period. It is approved in a total of x countries and available in a total of y countries
worldwide. The patient treatment years/number of patients treated are estimated to have been X within
the reporting period.]

II.2    QUALITY

[Relevant quality issues in the past 5 years should be summarised here, as well as a discussion on all
remaining issues that will be requested as Follow-Up Measures and reflected in the Letter of
Undertaking.]


II.3    NON-CLINICAL

<The MAH confirmed that no new non-clinical data are available since the granting of the <initial
marketing authorisation> / <last renewal> to the present application.>

[Relevant non-clinical issues in the past 5 years should be summarised here, as well as a discussion
on all remaining issues that will be requested as Follow-Up Measures and are reflected in the Letter
of undertaking.]


II.4    CLINICAL EFFICACY AND SAFETY

                                                                           Renewal AR - rev. 1- 2007
[For the whole section: include a discussion on all remaining issues that are reflected in the Letter of
undertaking.]
II.4.1 Clinical Efficacy

[Brief discussion of the relevant studies during the period covered and their outcome with regards to
clinical efficacy]

[Critical review of the efficacy of the product during the past years should be made. Please mention
open or new clinical studies/new commitments/literature etc relating to efficacy.]


II.4.2 Clinical Safety

II.4.2.1 Cumulative experience <period>

[This overview should discuss relevant safety data collected up to the time of the renewal since the
granting of the original marketing authorisation/ last renewal.]

[Give an overview of the product usage, i.e. number of countries where it is approved/marketed and
cumulative exposure.]

[A short summary of salient matters that have arisen from previous PSURs should be given as well as
the list of continuous monitoring that had been agreed upon based on them]

[A short overview of safety studies should be given]

[Any measures in regards to the Pharmacovigilance System should be reflected here.]

[Any measures in regards to a Risk Management Plan should be reflected here.]



II.4.2.2 Report of Post Marketing Experience <period>

In addition, the MAH submitted within the renewal dossier <a PSUR> / <a PSUR + line -
listing/summary tabulation> / <a PSUR + PSUR Addendum Report> / <a line-listing/summary
tabulation or PSUR Addendum Report> /<a summary bridging report> covering the period < >.

[Please consider for this paragraph the current PSUR or LL submitted with the renewal application.
The summary and conclusion as well as the new issues rising from this PSUR (new follow-up
measures) should be given. Mention any changes arising from such evaluation.]


II.4.2.3 Conclusion on Safety

[A critical review of the safety of the product during the past years should be made. Please mention
open or new FUMs / SOBs, changes to the PSUR cycle or safety issues under monitoring]

[If an additional renewal is being requested, please elaborate here. Please also refer to the guidance
on the Criteria for an additional renewal.]




                                                                             Renewal AR - rev. 1- 2007
[Discuss the PSUR cycle, especially in the transitional phase1 , and according to the new legislation.]:

<The MAH submitted a <period> <PSUR> / <or alternatives>. The medicinal product <having been>
/ <not having been> renewed before 20 November 2005 and <being> / <not being> currently
marketed, the next PSUR submission is due by < Month YYYY>.>

[For     further     clarification,   please    refer             to      the      following       guidance:
http://www.emea.eu.int/pdfs/human/euleg/33861205en.pdf]


II.5    PRODUCT INFORMATION

<The MAH proposed changes to the Product Information (PI), which were reviewed during the
assessment of this renewal application (see Attachment X (= Present/Proposed) of this Assessment
Report).>

<The MAH proposed no changes to the Product Information (PI) during this procedure.>

<The Rapporteur and Co-Rapporteur request <further amendments to the PI <as discussed in detail
above.> [refer to the scientific discussion above] / <the following additional amendments to the
Product Information:> [Description in brief of the paragraphs of the PI where the Rapporteur and Co -
Rapporteur request further amendments to the proposed changes.]

[If user consultation results were submitted within this procedure, please include the assessment of the
results here as well.]


II.6    POST-APPROVAL COMMITMENTS TO BE FULFILLED BY THE MAH

The Rapporteur and Co-Rapporteur propose the following post-approval commitments:

Area1                  Description                                                          Due date2
Pharmacovigilance      <The MAH will continue to submit <6 monthly> / <yearly>              ../../..
                       PSURs unless otherwise specified>
                                                                                  ../../..
1
  Areas: Quality, Non-clinical, Clinical, Pharmacovigilance
2
  Due date for the follow-up measure or for the first interim report if a precise date cannot be
committed to.




1
  Transitional measures for submission of PSURs for CAPs (EMEA/338612/2005) were published by the EMEA
in liaison with the European Commission to provide information on the implementation of the new PSUR
provisions for medicinal products authorised before 20 November 2005: with regards to these products, the next
PSUR submission should be clarified accordingly in this section (i.e. with regards to MAs not yet or already
renewed before 20 November 2005, taking into account the marketing status of the medicinal product).
                                                                                    Renewal AR - rev. 1- 2007
II.7    CONCLUSIONS ON THE BENEFIT RISK BALANCE OF THE PRODUCT

[Include here a critical review of the benefit/risk balance of the product, and conclude the section with
one of the following statements:]

<The Rapporteur and Co-Rapporteur are of the opinion that the renewal can be granted with unlimited
validity.>

<The Rapporteur and Co-Rapporteur are of the opinion that one additional five-year renewal on the
basis of pharmacovigilance grounds is required.>

[In case of the requirement of one additional renewal, please elaborate here.]

[If applicable, include a sentence about products under exceptional circumstances:]

<Since all Specific Obligations have been fulfilled, the Rapporteur and Co-Rapporteur are of the
opinion that there are no grounds to maintain the Marketing Authorisation under exceptional
circumstances.>

<Since there are remaining Specific Obligations, the Rapporteur and Co-Rapporteur are of the opinion
that the Marketing Authorisation should remain under exceptional circumstances.>


OR:


II.7    LIST OF OUTSTANDING ISSUES
[List here, according to grade “major/other” and scientific area “quality, non -clinical, clinical
safety/efficacy” the points to be address by the MAH in their response to the LoOI and also any
changes to the Product Information. Alternatively, you may attach a PI with your comments.]

! PLEASE NOTE: In case of a List of Outstanding Issues the Conclusions on the Benefit Risk
Balance of the Product have to be addressed in the Assessment Report on the Responses in the
frame of an update of this AR!




                                                                             Renewal AR - rev. 1- 2007

				
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