PRAC Rapporteur Risk Managment Plan Assessment Report Template

PRAC Rapporteur Risk Management Plan (RMP) Assessment Report

(For initial application, recommended for extension of indication, major line extension and optional for others)

[Active substance(s) (INN or common name)]

[Pharmaco-therapeutic group (ATC Code)]

[Marketing Authorisation Holder or Applicant]:

Number of medicinal products to which this RMP refers: Choose an item.

Date of final sign off of first RMP Version number

covered by this AR

Date of final sign off of last RMP Version number

Covered by this AR

This assessment report is dated Click here to enter a date. and is the Choose an item.

ADMINISTRATIVE INFORMATION

Name of the (PRAC) Rapporteur / Name
Email:
(PRAC) Rapporteur contact person: / Name:
Tel:
Email:
Names of the (PRAC) Rapporteur’s assessors / Name
Email:
Name
Email:
Name
Email:
Name of the (PRAC) Co-Rapporteur / Name
Email:
(PRAC) Co- Rapporteur contact person: / Name:
Tel:
Email:
EMA Risk Management Team Leader/MS Risk Management contact point / Name
Email:

Table of contents

1. List of abbreviations 5

2. Background information on the procedure 5

3. Part I “Product overview” 6

4. <PRAC Rapporteur< Assessor> current recommendations to PRAC following the <initial assessment<responses to the LoQ<responses to the list of outstanding issues<request for supplementary information> 7

4.1. Current recommendations on conditions or restrictions with regard to the safe and effective use of the medicinal product 7

4.1.1. Risk management system 8

4.1.2. Additional risk minimisation measures 9

4.1.3. Obligation to conduct post-authorisation measures 9

4.2. PRAC discussion 10

5. Safety Specification 10

5.1. Epidemiology of the indications and target population 10

5.2. Non-clinical part of the safety specification 10

5.3. Clinical trial exposure 10

5.4. Populations not studied in clinical trials 10

5.5. Post - authorisation experience 10

5.6. Additional EU requirements for the safety specification 10

5.7. Identified and potential risks 11

5.7.1. New information (post authorisation RMPs only) 11

5.7.2. Assessment of identified and potential risks 11

5.7.3. Rapporteur’s conclusions on Module SVII Identified and potential risks: 11

5.8. Summary of the safety concerns 11

5.9. Conclusions on the safety specification 12

6. Part III Pharmacovigilance plan 12

6.1. Summary of planned additional PhV activities (if appropriate) 12

6.2. Additional pharmacovigilance activities to assess the effectiveness of risk minimiation measures (see also section 7.1) 13

6.3. Studies and other activities completed since last update of PhV Plan 13

6.4. Overall conclusions on the PhV Plan 13

7. Part IV “Plans for post-authorisation efficacy studies” 13

7.1. Applicability of efficacy to all patients in the target population 13

7.2. Summary of Post authorisation efficacy development plan 14

8. Part V “Risk minimisation measures” 14

8.1. Additional risk minimisation measures 14

8.2. Assessment of effectiveness 15

8.3. Conclusions on risk minimisation measures 15

9. Part VI “Summary of activities in the risk management plan by medicinal product” 15

9.1. <Product name> 15

9.1.1. Summary of safety concerns 16

9.1.2. Summary of additional risk minimisation measures by safety concern (if any) 16

9.1.3. Summary of changes to the risk management plan over time 16

9.1.4. Overall conclusions on Public Summary 16

10. PRAC Rapporteur’s initial conclusions 16

11. <List of questions<list of outstanding issues<request for supplementary information> 17

12. Assessment of responses to the <List of questions<list of outstanding issues<request for supplementary information> 17

13. PRAC Rapporteur’s conclusions following the response to the <List of questions<list of outstanding issues<request for supplementary information> 18

14. <List of questions<list of outstanding issues<request for supplementary information> 18

15. Assessment of responses to <List of questions<list of outstanding issues<request for supplementary information> 18

1. List of abbreviations

Abbreviation / Non-abbreviated form /
MAH / Marketing Authorisation Holder

2. Background information on the procedure

< Name of MAH/MAA> submitted a RMP version < Choose an item.

The procedure started on Click here to enter a date.

Select the following sentences as appropriate

The RMP was updated following a List of Questions

The RMP was updated following a List of Outstanding Issues

The RMP was updated following a request for supplementary information

3. Part I “Product overview”

Invented name(s) in the European Economic Area (EEA)
Authorisation procedure / Choose an item.
Authorisation number (s)
Brief description of the product including:
chemical class
summary of mode of action
important information about its composition (e.g. origin of active substance of biological, relevant adjuvants or residues for vaccines
Indication(s) in the EEA
Current (if applicable)
Proposed (if applicable)
Dosage in the EEA
Current (if applicable)
Proposed (if applicable)
Pharmaceutical form(s) and strengths
Current (if applicable)
Proposed (if applicable)

This section should be completed each time the RMP is assessed eg initially and after each set of responses. Please select the appropriate option above to reflect what stage the procedure is at

The points should be detailed and if necessary the update period specified in 4.2.1.

<The RMP could be acceptable provided an updated RMP and satisfactory responses to the <list of questions<list of outstanding issues<request for supplementary information> at the end of this assessment report are submitted>

4.1. Current recommendations on conditions or restrictions with regard to the safe and effective use of the medicinal product

This section should be completed each time the RMP is assessed so that the recommendations to PRAC always reflect the current status.

Conditions or restrictions with regard to the safe and effective use of the medicinal products now have 3 sections:

· RMP

· Additional risk minimisation measures

· Obligation to conduct post-authorisation measures.

There is default text regarding RMPs in the current CAP Opinion templates which should be routinely included as a condition in all MAs to make them legally enforceable

The statement below can be included if required in the early stages of the procedure provided this is not the final RMP AR for the procedure

4.1.1. Risk management system

For MRP/DCP/NAPs this should be included (if required)

An updated RMP should be submitted:

· At the request of the national competent authority;

· Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.

If the submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.

Next update to the Risk management system

“Routine” updates to the RMP are no longer allowed by the EC so updates will normally only occur when triggered – eg by a significant change to the MA, or a new safety concern. When justified on a proportionate risk based approach, the PRAC Rapporteur/assessor may advise a deadline for the submission of the next update to the RMP in which case the sentence below should be included along with an appropriate timescale. For less urgent updates, ‘with the next PSUR or variation’ may be an appropriate timeframe. If the recommendation to PRAC is that the “RMP could be acceptable” and the RMP was submitted as either a stand-alone RMP or with a PSUR, then a time-scale should be provided and justified. “With the response to the LoQ etc” should only be chosen during a procedure eg initial MAA, variation etc.

4.1.2. Additional risk minimisation measures

no additional risk minimisation measures are necessary>

< The PRAC Rapporteur<assessor> considers that the following additional risk minimisation measures are necessary for the safe and effective use of the product:

If this option is chosen Select all that apply

< Educational material for healthcare professionals to address the risk(s) of

list safety concerns to be addressed>

< Educational material for <patients<and/or carers> to address the risk(s) of

list safety concerns to be addressed

<Other

Or Post authorisation only

The PRAC Rapporteur<assessor> considers that <the following> conditions or restrictions are no longer necessary for the safe and effective use of the medicinal product[specify any measures no longer considered necessary]

4.1.3. Obligation to conduct post-authorisation measures

This relates to imposed studies (Annex II conditions for CAPs)

no conditions are necessary>

[Or if new PhV studies or activities are needed, for EACH new study/activity which should be an Annex II condition]

< The PRAC Rapporteur<assessor> recommends that a <study<activity> to investigate <name safety concern(s)> should be a condition of the MA>

[Optional statement]

< The PRAC Rapporteur<assessor> recommends that this should take the form of a < Choose an item. >

4.2. PRAC discussion

This RMP need discussion during the PRAC Plenary Yes No

Provide brief outline of areas for discussion and give references to relevant sections of AR.

ASSESSMENT OF THE PARTS OF THE RMP

5. Safety Specification

5.1. Epidemiology of the indications and target population

5.2. Non-clinical part of the safety specification

Briefly summarise the important non-clinical findings eg on key target organs. For any medicine intended for use by women of reproductive age always include repro tox findings. Comment on the overall findings and their relevance to human use

5.3. Clinical trial exposure

5.4. Populations not studied in clinical trials

Comment on the relevance of the clinical trial population to the intended target population (inclusions, exclusions, limited numbers, trial setting, use in special populations. Comment on implications of scarce or missing information in relation to use in the target population

5.5. Post - authorisation experience

Comment on any regulatory action for safety reasons. Comment on any post-authorisation use in the populations with no or limited exposure during clinical trials. Comment on any off-label use

5.6. Additional EU requirements for the safety specification

Potential for harm from overdose, transmission of infectious agents and potential for misuse for illegal purposes

Potential for medication errors

This is one of the important parts of the safety specification.

Consider whether the MAA has analysed adequately any medication errors which have occurred in the clinical trial population? What are the implications?

Assess common sources of medication errors (e.g. product name, presentation, instructions for use, labelling) and discuss the potential for serious harm. Are there similar products containing the same active substance on the market where as a result of confusion (e.g. different strength, posology or method of reconstitution) medication error could occur? If a device is involved, what are the possible consequences of device failure? Also consider whether there are any important implications for special patient populations – eg problems in measuring a dose for small children. If appropriate, medication error should be included as a safety concern (important identified or potential risk). Consideration should be given as to whether additional PV activitiesto identify the frequency or causes of medication error and/orrisk minimisation measures are necessary to minimise the risk. If required, also mention in the appropriate section

Potential for off-label use

Specific paediatric issues

Comment on whether there is a current or proposed paediatric indication. What is the likelihood of off-label paediatric use and based on the likelihood, should use in children be a safety concern? Are there issues from any PIP which needs to be discussed in the RMP?

5.7. Identified and potential risks

5.7.1. New information (post authorisation RMPs only)

Newly identified safety concerns (from table SVII.1 of the RMP)

Comment on whether there have been newly identified safety concerns and any implications for the rest of the RMP.