EMACOLEX, May 2011

Recent activities of the HMA/EMA Transparency Group

Tina Engraff

Legal Adviser, Danish Medicines Agency

EMACOLEX, May 2011

• Background & purpose

• Membership

• Outcomes

• Current activities

• Future activities

EMACOLEX, May 2011

Background and purpose

• New transparency provision in the Review 2001

• Need for harmonised approach between MS

• Questionnaires and meetings at EMA with all MS represented

• Smaller group emerged to take concrete actions forward

• Ad hoc tasks

• Produce guidance to facilitate a harmonised approach across EU, if possible

EMACOLEX, May 2011

Membership

• EMA, NL, ES, PT, DE, SE and DK

– CMD(v) also involved, when relevant

• EMA and NL co-chairs

– Emer Cooke and Truus Janse-de Hoog

• Pharmacists, biologist, international affairs, communication and lawyers

EMACOLEX, May 2011

Outcomes (1)

• Recommendations on transparency related to agendas/minutes on product related issues

– http://www.hma.eu/uploads/media/Recommendations_on_transparency.pdf

• Recommendations on the handling of requests for access to PSURs

– http://www.hma.eu/uploads/media/HMA_EMEA_Reccomendations_on_Transparency20091123.pdf

EMACOLEX, May 2011

Outcomes (2)

• Recommendations on release of information with regard to new applications for medicinal products

– http://www.hma.eu/uploads/media/HMAEMA_Recommendations_NAReleaseinformation.pdf

• Consultation procedure between NCAs in the EU when 3rd parties request access to assessment reports that have been written in the context of an European procedure involving more than one MS

– Not to be published

EMACOLEX, May 2011

Current activities

• HMA/EMA guidance document on the identification of CCI and protection of personal data within the structure of the MA dossier – Release of information after the granting of a MA

– CMD(h) + national lawyers had meeting 17 March

– At HMA meeting in April 2011 agreed that a public consultation (3 months) could take place

– Final version anticipated at HMA meeting in November 2011

– Final version to be published

EMACOLEX, May 2011

Future activities

• Further work on guidance on access to dossier

• Input to implementation of transparency issues in the new PhV legislation

– Members of the HMA/EMA Transparency Group participates in project teams

• Possible input to idea of having dossier divided into confidential part and non-confidential part

EMACOLEX, May 2011

Thank youThank you