Policies and procedures

The European Medicines Agency's (EMA) policies and procedures ensure that our long-term vision and goals are translated into concrete steps. They set the boundaries for all major EMA decisions and actions.

Updated 22/02/2024
"Procedures" section

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 essential in ensuring the effective planning of processes. 

They lay down the rules to be followed. This ensures that actions and decisions taken in the design and operation of processes serve the business objectives, and the needs and expectations of stakeholders.

Policy 1: Quality Management Policy

AdoptedReference Number: EMA/228979/2024Legal effective date: 01/07/2024

Policy 4: Health and safety

AdoptedReference Number: EMA/65832/2011Legal effective date: 06/09/2012

Policy 9: Appropriate coordination between the Agency's scientific committees

AdoptedReference Number: EMEA/124704/2005 Rev. 1Legal effective date: 31/10/2008

Policy 15: Policy on publications by EMA staff and EMA scientific committee members on EMA’s work

AdoptedReference Number: EMA/33844/2022Legal effective date: 01/01/2025

Policy 26: Records management and archives policy

AdoptedReference Number: EMA/16533/2024Legal effective date: 15/04/2025Summary:

Supersedes: EMA/132696/2018 (dated 10 July 2019)

Policy 29: Representing the Agency at external events or in professional bodies

AdoptedReference Number: EMA/550476/2024Legal effective date: 01/01/2025

Policy 43: European Medicines Agency policy on access to documents

AdoptedReference Number: EMA/729522/2016Legal effective date: 01/12/2010

Policy 44: European Medicines Agency policy on the handling of competing interests of scientific committees’ members and experts

AdoptedReference Number: EMA/136875/2022Legal effective date: 01/01/2023

Policy 46: European Medicines Agency policy on video surveillance

Reference Number: EMA/316049/2024Legal effective date: 01/01/2025

Policy 51: Stress at work

AdoptedReference Number: EMA/458250/2009 Version 1.1Legal effective date: 01/12/2021

Policy 54: Personal electrical equipment

AdoptedReference Number: EMA/256085/2009Legal effective date: 01/06/2021

Policy 56: Support to staff subject to external accusations and attacks

AdoptedReference Number: EMA/868270/2011Legal effective date: 27/05/2013

Policy 58: European Medicines Agency policy on the handling of competing interests of Management Board members

AdoptedReference Number: EMA/MB/89374/2020 Rev.1Legal effective date: 01/01/2023

Policy 70: European Medicines Agency policy on publication of clinical data for medicinal products for human use

Reference Number: EMA/144064/2019Summary:

The aim of the European Medicines Agency ('the Agency') is to protect and foster public health. Transparency is a key consideration for the Agency in delivering its service to patients and society.

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...

AdoptedReference Number: EMA/283205/2013 Rev. 1Summary:

The European Medicines Agency's (hereinafter referred to as EMA) main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use.

Policy 78: EMA environmental policy

Reference Number: EMA/83225/2024Summary:

As an EU body the European Medicines Agency acknowledges its institutional responsibility to safeguard the environment for present and future generations. Recognising that social and civil responsibilities of the Agency’s activities have the potential to affect the environment, we believe that a long term sustainable approach and proactive environmental management generates environmental, social and economic value for the community in which it operates.

Policy 81: Document classification policy

AdoptedReference Number: EMA/174602/2016

Policy 82: Union Product Database (UPD) Access Policy - Veterinary Medicinal Products

AdoptedReference Number: EMA/259966/2024Legal effective date: 01/08/2024

Policy 83: Visiting and collaborating experts involved in the activities of the European Medicines Agency

AdoptedReference Number: EMA/55453/2022Legal effective date: 01/01/2025

Policy 84: Multilingualism on the EMA website and in external communications

Reference Number: EMA/723437/2022

Policy 85: Identity and Access Management to EMA IT Systems

AdoptedReference Number: EMA/553746/2024Legal effective date: 24/03/2025

Procedures

Procedures are specific methods to implement policies in day-to-day operations. At EMA, they include: 

• Business process descriptions
• Work instructions
• Standard operating procedures

Business process descriptions

Business process descriptions outline the key steps and phases of an end-to-end business process.

They are available in the following areas:

• Committee management
• Expert management
• Inspection coordination
• Marketing authorisation
• PSUSA and other related post-authorisation processes
• Scientific meeting management
• Orphan status management
• Paediatrics medicines development
• Pharmacovigilance
• Medical devices
• Parallel distribution
• Certificates
• Quality defect and non-compliance
• Referral procedure
• Regulatory and Scientific Guidelines
• Sampling and testing of CAPs
• Scientific advice
• Translations
• Variations and other related processes

Work instructions 

Work instructions contain detailed descriptions of how to perform and record tasks. 

They may include detailed written descriptions, flow charts, checklists, pictures, or combinations thereof.

They are available in different areas, from general procedures to referrals. For more information on these areas, see the section below on 'Standard operating procedures'.

Standard operating procedures 

Standard operating procedures contain detailed, written instructions to achieve process-specific uniformity. 

They usually cover more than one task or area within EMA, unit or sector.

Standard operating procedures and work instructions are available in the following areas:

• General procedures
• Inspection activities
• Meeting management
• Pharmacovigilance
• Product authorisation lifecycle
• Product development
• Product information
• Referrals