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Standard operating procedure Title: Hand over file Status: PUBLIC Document no.: SOP/EMA/0127 Lead author Approver Effective date: 01-APR-2013 Name: Frances Nuttall Name: Andreas Pott Review date: 01-APR-2016 Signature: On file Signature: On file Supersedes: [TW 3729] SOP/EMA/0127 (01-DEC-2012) Date: 20-MAR-2013 Date: 24-MAR-2013 TrackWise record no.: 3815 1. Purpose The SOP is in compliance with the internal control standards (EMA/MB/555181/2010) and in particular ICS 3: staff allocation and mobility and ICS 10: business continuity. The purpose of a handover is to ensure continuity of operations when the staff member, usually responsible, is not available due to temporary or permanent absence. A handover can be supported by a discussion to explain the status of the tasks, a summary of the work status in an e- mail/memorandum or, a more detailed file. For consistency and the efficient running of the Agency s work it is important that, in the event of planned absence of staff, the business is allowed to continue smoothly. Good information and comprehensive communication is the key factor for a valuable hand over to the named back up or successor taking over the duties. When a staff member leaves the Agency for a long scheduled absence or indefinitely the person taking over the duties needs to have a clear picture of the objectives and role and responsibilities of the job in question. It is important that they have an understanding of the role they are taking on and how it relates to the mission of the Agency. Therefore they need to receive the relevant information which will enable them to continue to carry on the duties in the most efficient way. In preparing a hand over not only the nature and context of the job must be considered (based on the job description) but it also needs to take into account the knowledge of the back-up/successor. Preparation for a handover (file/or discussion) means that relevant information needs to be maintained (paper and /or electronic), on a continuing basis. The SOP also addresses general issues that need to be considered in every handover. 7 Westferry Circus Canary Wharf London E14 4HB United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8416 E-mail info@ema.europa.eu Website www.ema.europa.eu An agency of the European Union European Medicines Agency, 2013. Reproduction is authorised provided the source is acknowledged.

2. Scope This SOP applies to all members of staff of the European Medicines Agency. 3. Responsibilities It is the responsibility of Head of Unit, Head of Sector and Section Head to ensure that this procedure is adhered to within their own unit, sector or section. It is the responsibility of each individual who are about to go on short / long term absences or leave their current position / the Agency to prepare a hand over file. The responsibility for the execution of a particular part of this procedure is identified in the right-hand column of section 9. 4. Changes since last revision New SOP which was previously a work instruction. 5. Documents needed for this SOP There is no specific template available for handovers because they will be different according to the length of absence and depending of the section/sector/unit as work can hugely vary throughout the Agency. 6. Related documents Internal Control Standards (EMA/MB/555181/2010) Individual Job Description Work Plan 7. Definitions The term file as used in this SOP refers to the relevant set of documents or the discussion to enable a handover. Back up: EMA colleague(s) named in the job description in the section - In case of absence duties assumed by: In order to ensure that back up colleague(s) named in the job description is able to easily take over the duties, particularly in the case of unplanned absence, it is essential that regular contacts within the team (e.g. sector meetings/bilateral) should take place. There should be on-going communication between the parties to ensure a good overall understanding of the tasks carried out. Filing should be up to date and regularly done (e.g. documents, files should be properly documented with notes to file so that follow up can be easily ascertained) or, the location of any outstanding filing should be agreed between parties. Short term absence: A short-term absence arises in the case of planned or unplanned leave (e.g. annual leave, special leave, short term sick leave or one month of parental/family leave/unpaid leave). SOP/EMA/0127 01-APR-2013 Page 2/7

The back-up person will take over the duties to the extent necessary for the short absence. It is important that there is regular communication with the back-up person, so that this person is aware of how the work and documents are organised as well as the status of tasks/actions. Long term planned absence: Examples of long-term planned absences are maternity leave, more than one month family/parental/unpaid leave, transfer to another unit/sector/section or, departure from the agency where staff will be replaced on the full time basis. The absence may be covered with a replacement person brought in to take over the duties of the post or there may be some re-assignment of the duties within the team together with a replacement person. In these cases there should be an overlap period so that the person(s) taking over the duties is/are properly trained / briefed by the outgoing colleague. Long term unplanned absence: It can arise due to long term sick leave. It is not always possible to prepare a detailed handover in case of unplanned absences. SOP/EMA/0127 01-APR-2013 Page 3/7

8. Process map(s)/ flow chart(s) START 1. Assess type of hand over needed oral Written 2. Prepare hand over 3. Train back up 3. Train back up 4. File hand over 5. Original Person returns Yes No 6. Briefing by back up END SOP/EMA/0127 01-APR-2013 Page 4/7

9. Procedure Step Action Responsibility 1 Assess type of hand over according to the length of absence Staff away on short term leave can prepare an oral hand over Individual staff (outgoing person) Staff going on long term planned absences or staff moving to a different section/sector/unit or leaving the Agency have to prepare a written hand over 2. Prepare hand over The hand over needs to take into account the knowledge of the back-up or replacing person. The hand over should contain information such as: Individual staff (outgoing person) HoU/HoS/SH/Group leaders Description of the duties and how they fit within the Agency/Unit/Sector/Section Training on protocol and procedures e.g. SOPs/WINs and explanation of relevant documents Advising status of on-going tasks Explanation on the objectives, priorities However, regarding the length of absence and the knowledge of the back-up, a written hand over may not always be required. For written hand over: the format can be either a WIN, a briefing note, a check list, or a schedule prepared to give all information in order to ensure the continuity of work. The annex to this SOP presents a suggestion of useful documents/information that could be included in a hand over file. The outgoing person has to make sure that the documentation concerned for the tasks is up to date and easily available, and if needed, revise it when preparing the hand over. 3. Train back up The departing person has to arrange the back-up briefing before their departure. For planned long term or permanent absence there should be, where possible, an overlap of the duties, ideally the person taking over should arrive prior to the departure of the agent in order to work shadow the staff leaving or, if such an overlap is not possible, an existing staff member could serve as a bridge. Individual staff concerned (outgoing person and back up) For a staff member going on short term absence the back-up person should be briefed in time before the person goes on leave to allow for any follow up questions. 4. File (electronic / paper) hand over Individual staff SOP/EMA/0127 01-APR-2013 Page 5/7

Step Action Responsibility 5. Notification of return of staff member 6. Feed back from hand over When the staff member returns from absence a hand over should be prepared to give updates on the status of the tasks. (Go to step 2 for guidance) Back up / successor 10. Records Hand over files are stored under: Cabinet 14. Business Areas Operations/ 14.Unit name / x-unit Administration / Staff Matters / Backups and Hand overs SOP/EMA/0127 01-APR-2013 Page 6/7

Annex SOP/EMA/0127 Suggested list of documents / information to be included in a hand over file For New staff: The Agency's mission statement Regulations relating to the business of the Agency as relevant to the position in question Annual Report (including summary) EMA Financial Regulations EMA Financial Implementing rules Internal Website addresses Institutions Website addresses For New staff and back-ups: Road Map Look at the Road Map as needed for the purpose of the job Work Programme Look at the Agency work programme as needed for relevant things linked to the job In the case of senior management, a report describing the achievements against annual objectives i.e. the most recent mid-year report, a description of measures for proper handover of documentation on operational and organisation issues, an indication of problems, existing or potential, that could be subject to a reservation in the next annual activity report and measures taken or proposed to solve them. Job description Agency / Unit / Sector / Section organisational charts Unit / sector / section / individual Work plan Look at the section / sector work plan, as applicable and identify any items or priorities for the role Position objectives and performance indicators Prepare, update a to-do list and advise on the status of each task and objective. What is needed is a summary of the current state of the work of the agent leaving their post, current and upcoming priorities, clear details of deadlines and subsequent tasks to be done and documentation concerned or where to find it, on-going for information, waiting for actions and by whom, urgent things to be chased up, particular deliverables which are expected. Description of each task with a workflow of the next steps for each activity. If these do not exist to prepare a coherent/informative summary to explain the steps to follow. Listing of relevant SOPs/WINs Annex SOP/EMA/0127 - PUBLIC SOP/EMA/0127 01-APR-2013 Page 7/7