Policies and procedures

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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:

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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Document(s) Language Status First published Last updated Effective Date
Policy 1: The European Medicines Agency's integrated quality management system (English only) adopted 2009-03-10   2009-03-10
Policy 4: Health and safety (English only) adopted 2010-04-22 2012-09-04 2012-09-06
Policy 9: Appropriate coordination between the Agency's scientific committees (English only) adopted 2008-10-31   2008-10-31
Policy 15: Scientific publications by European Medicines Agency staff (English only) adopted 2010-04-22   2008-06-10
Policy on scientific publication and representation for European Medicines Agency scientific committees and their members (English only) adopted 2006-05-10 2010-12-21  
Policy 26: Records management (English only) adopted 2010-04-22 2016-04-14 2014-07-10
Policy 29: Replies to external requests for contributions by European Medicines Agency staff (English only) adopted 2010-07-21   2010-07-22
Policy 33: Communication on (emerging) safety related issues for medicines for human use (English only) adopted 2010-07-20   2010-07-20
Policy 43: European Medicines Agency policy on access to documents (related to medicinal products for human and veterinary use) (English only) adopted 2010-11-30   2010-12-01
Policy 44: European Medicines Agency policy on the handling of declarations of interests of scientific committees’ members and experts (English only) adopted 2010-10-14 2017-01-11 2016-12-01
Policy 46: Video surveillance (English only) adopted 2012-09-14 2015-07-30 2015-01-01
Policy 51: Stress at work (English only) adopted 2011-03-21   2011-03-18
Policy 54: Personal electrical equipment (English only) adopted 2012-09-04   2012-10-18
Policy 56: Support to staff subject to external accusations and attacks (English only) adopted 2013-05-27   2013-05-27
Policy 58: European Medicines Agency policy on the handling of competing interests of Management Board members (English only) adopted 2016-10-07   2016-12-01
Policy 63: Mail management (English only) adopted 2012-10-08   2012-09-24
Policy 65: Working with training or event providers (English only) adopted 2013-01-07   2013-01-09
Policy 69: Transfer of access-control data from the security access-control system (English only)   2013-04-17    
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 and veterinary medicinal products (English only) adopted 2017-04-10    
Policy 77: EMA policy on visiting experts (English only) adopted 2015-03-25    
Policy 78: EMA environmental policy (English only)   2015-05-12 2016-11-17  
Policy 81: Document classification policy (English only) adopted 2016-12-15