Transparency policy

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The European Medicines Agency has published a draft transparency policy that sets out how the Agency intends to provide for greater clarity and openness in all areas of its operations.

The objectives of the transparency policy are:

  • to apply a more proactive approach to transparency in the daily operations of the Agency;
  • to further strengthen interaction with the Agency’s stakeholders;
  • to promote co-operation on transparency issues within the European medicines network.

Public consultation

The Agency released the draft policy for public consultation between June and September 2009. The Agency is processing the comments received during the consultation.

Workshops

The Agency has hosted two workshops to provide an opportunity for discussion on the draft policy with stakeholders.

The first workshop took place on 22 January 2009, and allowed attendees to express their initial thoughts and provide feedback on their understanding and expectations on the level of transparency of Agency activities. The Agency invited members from patients’, consumers’ and healthcare professionals’ organisations, learned societies and farmers’ unions to attend, as well as representatives from European pharmaceutical industry associations.

The workshop addressed issues concerning commercially confidential information was addressed with input from the joint European Medicines Agency/Heads of Medicines Agencies Group on Transparency and from the European Medicines Agencies Cooperation on Legal Issues (EMACOLEX).

A second workshop took place at the Agency on 19 October 2009.

Table of contents


Transparency policy

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Document(s) Language Status First published Last updated Effective Date
The European Medicines Agency transparency policy draft for public consultation (English only) draft: consultation closed 19/06/2009    

Guidance and recommendations from the Heads of Medicines Agencies and the European Medicines Agency

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Document(s) Language Status First published Last updated Effective Date
Overview of comments received on 'Heads of Medicines Agencies / European Medicines Agency guidance document on the identification of commercially confidential information and protection of personal data within the structure of the marketing-authorisation dossier – release of information after granting of a marketing authorisation' (English only)   15/06/2012    
Principles to be applied for the implementation of the Heads of Medicines Agencies / European Medicines Agency guidance on the identification of commercially confidential information and protected personal data in marketing-authorisation applications (English only) adopted 27/03/2012    
Heads of Medicines Agencies / European Medicines Agency guidance document on the identification of commercially confidential information and personal data within the structure of the marketing-authorisation application: Release of information after the granting of a marketing authorisation (English only) adopted 27/03/2012    
Draft Heads of Medicines Agencies/European Medicines Agency guidance document on the identification of commercially confidential information and protection of personal data within the structure of the marketing-authorisation dossier - release of information after granting of a marketing authorisation (English only) draft: consultation closed 01/06/2011    
Heads of Medicines Agencies/European Medicines Agency recommendations on transparency: Recommendations on release of information with regard to new applications for medicinal products before and after opinion or decision on granting of a marketing authorisation (English only)   06/12/2010    
Recommendations on transparency related to agendas/minutes on product related issues (implementation of Article 126b of Directive 2001/83/EC as amended and Article 80 of Regulation (EC) No 726/2004) (English only)   20/11/2008    
Heads of Medicines Agencies/European Medicines Agency recommendations on transparency: Recommendations on the handling of requests for access to periodic safety update reports (English only)   03/12/2009