Policies and procedures

The European Medicines Agency's (EMA) 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 procedures
• 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.

Policy 1: Quality Management Policy

AdoptedLegal effective date: 01/07/2024Reference Number: EMA/228979/2024

Policy 4: Health and safety

AdoptedLegal effective date: 06/09/2012Reference Number: EMA/65832/2011

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

AdoptedLegal effective date: 31/10/2008Reference Number: EMEA/124704/2005 Rev. 1

Policy on scientific publication and representation for European Medicines Agency scientific committees and their members

AdoptedReference Number: EMEA/231477/2005 Rev. 1

Policy 26: Records management

AdoptedLegal effective date: 11/07/2019Reference Number: 0026Summary:

Supersedes: Version 17-SEP-08

Policy 29: Replies to external requests for contributions by European Medicines Agency staff

AdoptedLegal effective date: 22/07/2010Reference Number: Policy/0029

Policy 43: European Medicines Agency policy on access to documents

AdoptedLegal effective date: 01/12/2010Reference Number: EMA/729522/2016

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

AdoptedLegal effective date: 01/01/2023Reference Number: EMA/136875/2022

Policy 46: European Medicines Agency policy on video surveillance

Reference Number: EMA/112862/2021

Policy 51: Stress at work

AdoptedLegal effective date: 01/12/2021Reference Number: EMA/458250/2009 Version 1.1

Policy 54: Personal electrical equipment

AdoptedLegal effective date: 01/06/2021Reference Number: EMA/256085/2009

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

AdoptedLegal effective date: 27/05/2013Reference Number: EMA/868270/2011

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

AdoptedLegal effective date: 01/01/2023Reference Number: EMA/MB/89374/2020 Rev.1

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. 1

Policy 77: EMA policy on visiting experts

AdoptedReference Number: EMA/449474/2013

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 80: European Medicines Agency policy on the use of expertise for specific tasks to be undertaken by the Agency

AdoptedReference Number: EMA/219979/2016Summary:

The European Medicines Agency (EMA) has at its disposal European experts who serve as members of the EMA scientific committees, working parties and other groups, or who perform inspections on behalf of EMA. They can be nominated by the Member States or by EMA itself. Detailed arrangements for the use of these experts have been published on the EMA website.

Policy 81: Document classification policy

AdoptedReference Number: EMA/174602/2016

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

AdoptedLegal effective date: 26/01/2021Reference Number: EMA/198149/2020 Corr.

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

Reference Number: EMA/723437/2022