Policies and procedures
The European Medicines Agency's policies and procedures ensure that the Agency's long-term vision and goals are translated into concrete steps. They set the boundaries for all major decisions and actions taken by the Agency.
Procedures
Procedures are the specific methods employed to express policies in action in day-to-day operations of the organisation. They include standard operating procedures (SOPs) and work instructions (WINs).
SOPs contain detailed, written instructions to achieve uniformity of the performance of a specific process. The instructions usually cover more than one task or area within the Agency, unit or sector.
WINs contain detailed descriptions of how to perform and record tasks. They may be, for example, detailed written descriptions, flow charts, checklists, pictures, or combinations thereof.
SOPs and WINs are available in the following areas:
- General
- Inspection activities
- Meeting management
- Pharmacovigilance
- Product authorisation lifecycle
- Product development
- Product information
- Referrals
Policies
A policy is any statement by the management at any level that is designed to constrain the actions and decisions of those it affects.
Policies are therefore essential in ensuring the effective planning of processes because they lay down the rules to be followed to ensure that actions and decisions taken in the design and operation of processes serve the business objectives and the needs and expectations of stakeholders.
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Policy 1: The European Medicines Agency's integrated quality management system (PDF/90.02 KB)
Adopted
First published: 10/03/2009
Last updated: 10/03/2009
Legal effective date: 10/03/2009
EMEA/MB/355781/2007Rev.1 -
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Policy 4: Health and safety (PDF/158.71 KB)
Adopted
First published: 22/04/2010
Last updated: 04/09/2012
Legal effective date: 06/09/2012
EMA/65832/2011 -
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Policy 9: Appropriate coordination between the Agency's scientific committees (PDF/43.36 KB)
Adopted
First published: 31/10/2008
Last updated: 31/10/2008
Legal effective date: 31/10/2008
EMEA/124704/2005 Rev. 1 -
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Policy on scientific publication and representation for European Medicines Agency scientific committees and their members (PDF/137.85 KB)
Adopted
First published: 10/05/2006
Last updated: 21/12/2010
EMEA/231477/2005 Rev. 1 -
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Policy 26: Records management (PDF/294.69 KB)
Adopted
First published: 22/04/2010
Last updated: 25/07/2019
Legal effective date: 11/07/2019
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Policy 29: Replies to external requests for contributions by European Medicines Agency staff (PDF/111.61 KB)
Adopted
First published: 21/07/2010
Last updated: 21/07/2010
Legal effective date: 22/07/2010
Policy/0029 -
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Policy 43: European Medicines Agency policy on access to documents (PDF/150.42 KB)
Adopted
First published: 30/11/2010
Last updated: 23/11/2018
Legal effective date: 01/12/2010
EMA/729522/2016 -
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Policy 44: European Medicines Agency policy on the handling of competing interests of scientific committees’ members and experts (PDF/870.19 KB)
Adopted
First published: 07/10/2004
Last updated: 04/01/2023
Legal effective date: 01/01/2023
EMA/MB/89351/2020 Rev.3 -
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Policy 46: European Medicines Agency policy on video surveillance (PDF/220.37 KB)
First published: 30/09/2021
EMA/112862/2021 -
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Policy 51: Stress at work (PDF/224.29 KB)
Adopted
First published: 21/03/2011
Last updated: 08/12/2021
Legal effective date: 01/12/2021
EMA/458250/2009 Version 1.1 -
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Policy 54: Personal electrical equipment (PDF/292.52 KB)
Adopted
First published: 01/07/2021
Legal effective date: 01/06/2021
EMA/256085/2009 -
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Policy 56: Support to staff subject to external accusations and attacks (PDF/127.33 KB)
Adopted
First published: 27/05/2013
Last updated: 27/05/2013
Legal effective date: 27/05/2013
EMA/868270/2011 -
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Policy 58: European Medicines Agency policy on the handling of competing interests of Management Board members (PDF/222.1 KB)
Adopted
First published: 04/01/2006
Last updated: 04/01/2023
Legal effective date: 01/01/2023
EMA/MB/89374/2020 Rev.1 -
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Policy 72: European Medicines Agency policy on handling of information from external sources disclosing alleged improprieties concerning EMA activities related to the authorisation, supervision and maintenance of human a... (PDF/252.34 KB)
Adopted
First published: 10/04/2017
Last updated: 20/04/2022
EMA/283205/2013 Rev. 1 -
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Policy 77: EMA policy on visiting experts (PDF/104.08 KB)
Adopted
First published: 25/03/2015
Last updated: 25/03/2015
EMA/449474/2013 -
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Policy 78: EMA environmental policy (PDF/128.96 KB)
First published: 12/05/2015
Last updated: 21/01/2021
EMA/229034/2020 -
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Policy 80: European Medicines Agency policy on the use of expertise for specific tasks to be undertaken by the Agency (PDF/80.02 KB)
Adopted
First published: 21/10/2020
EMA/219979/2016 -
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Policy 81: Document classification policy (PDF/327.08 KB)
Adopted
First published: 15/12/2016
Last updated: 15/12/2016
EMA/174602/2016