European Medicines Agency Standard Operating Procedure - Checklist of mandatory input to annual management review - Annex II to SOP/EMEA/0029 - conducting the annual management review

Sep 13, 2026

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Checklist for mandatory reporting elements that must feed into the European Medicines Agency (EMEA) annual management review. Defines mandatory inputs as outputs from ongoing monitoring and provides guidance that the checklist is non-exhaustive, to be completed by relevant sectors or units. Specifies the need to indicate timing for each reporting element aligned with the annual review schedule set by top management, and encourages one-page executive summaries with suggested actions and resource implications.

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Pages2

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Mandatory reporting elements to feed into the management review

Reporting checklist by element (1-14)

Timing and executive summaries

European Medicines Agency Standard Operating Procedure | Title of document:
Checklist of mandatory input to annual management review | | Annex II to SOP/EMEA/0029:
conducting the annual management review | | --- | --- | --- | | Applies to: all EMEA staff and management | | Document ref.: EMEA/6310/2006 | | Prepared by: C Christiansen | Approved by: T Lönngren | Effective date: 06 MAR 06 | | Signature: on file
Date: 03 MAR 06 | Signature: on file
Date: 03 MAR 06 | Review date: 05 MAR 08 | | | | Supersedes: n/a | MANDATORY REPORTING ELEMENTS TO FEED INTO THE MANAGEMENT REVIEW • Mandatory elements are defined as reports which are part of the ongoing monitoring of activities, and which are required as input for each management review. • The checklist below is intended to serve as a reminder. The list should be considered nonexhaustive. The relevant sector or unit is invited to complete the list by adding other reports that may need to feed into the management review to the checklist. • It is recommended that an annual review of the checklist be carried out, to ensure that it is up-todate and covers actual reporting carried out. • The timing of the individual reporting element should be indicated in the column headed ‘timing’. This should be set in view of the timing of the overall management review, as decided by top management at the beginning of each year; and other deadlines and tasks of the respective unit/sector. • The responsible unit/sector is invited to use the checklist as part of their planning tools and indicate timings/deadlines as appropriate. • One-page executive summaries of the various reporting elements should be prepared, to include suggested action and estimated resource implications. | | REPORTING ELEMENT | RESPONSIBILITY | TIMING | | --- | --- | --- | --- | | 1 | Roadmap
Report main outcomes, feedback from previous actions, and suggestions for future actions to top management. | All sectors and units. Reports co-ordinated by NW | Spring/Summer | | 2 | Conduct environmental assessment.
Report main outcomes, feedback of previous actions, and suggestions for future actions to top management. | All sectors and units | In accordance with agreed reporting cycle | | 3 | Conduct internal audits
Report main outcomes, feedback of previous actions, and suggestions for future actions to top management. | IQM/audit | In accordance with agreed programme | | 4 | Follow-up on findings from external audits by the Court of Auditors and the EC’s IAS. Report main outcomes, feedback of previous actions, and suggestions for future actions to top management. | All sectors and units | Determined by CoA’s or IAS’s schedules | | --- | --- | --- | --- | | 5 | Follow-up on comments and suggestions contained in report from discharge authority. Report main outcomes, feedback of previous actions, and suggestions for future actions to top management. | All sectors and units | | | 6 | Conduct ISO/BEMA self-assessment, expanded to incorporate internal control review, cf. ICS no. 24.
Report main outcomes, feedback of previous actions, and suggestions for future actions to top management. | All sectors and units | In accordance with agreed IQM/Audit programme | | 7 | Conduct review of follow-up action to management review from year N-1 .
Report main outcomes, feedback of previous actions, and suggestions for future actions to top management. | Relevant sectors and units | Part of management review of year N | | 8 | Report on financial outcome, annual accounts.
Report main outcomes, feedback from previous actions, and suggestions for future actions to top management. | Accounting Sector | Set by Financial Regulation | | 9 | Annual Activity Report
Report main outcomes, feedback from previous actions, and suggestions for future actions to top management. | All sectors and units | Mid-year? | | 10 | Conduct annual risk assessment in accordance with ARM procedure (ref. ICS no. 11) .
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FAQs

What are mandatory reporting elements for the annual management review?

Mandatory elements are reports forming part of ongoing monitoring activities and required as input for each management review. The checklist below acts as a reminder and is non-exhaustive.

How should the timing of each reporting element be determined?

The timing should be set in view of the overall management review schedule decided by top management at the beginning of each year, and considering other deadlines of the respective unit or sector.

What should executive summaries include for each reporting element?

One-page executive summaries should include suggested actions and estimated resource implications, covering the main outcomes, feedback from previous actions, and future actions.

Sep 13, 2026

Upload by Mali