1. EMACOLEX, May 2011 Recent activities of the HMA/EMA Transparency Group Tina Engraff Legal Adviser, Danish Medicines Agency

2. EMACOLEX, May 2011 Background & purpose Membership Outcomes Current activities Future activities

3. 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

4. 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

5. EMACOLEX, May 2011 Outcomes (1) Recommendations on transparency related to agendas/minutes on product related issues –http://www.hma.eu/uploads/media/Recommendations_on_tra nsparency.pdfhttp://www.hma.eu/uploads/media/Recommendations_on_tra nsparency.pdf Recommendations on the handling of requests for access to PSURs –http://www.hma.eu/uploads/media/HMA_EMEA_Reccomendat ions_on_Transparency20091123.pdfhttp://www.hma.eu/uploads/media/HMA_EMEA_Reccomendat ions_on_Transparency20091123.pdf

6. 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_Recommendatio ns_NAReleaseinformation.pdfhttp://www.hma.eu/uploads/media/HMAEMA_Recommendatio ns_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access to assessment reports that have been written in the context of an European procedure involving more than one MS –Not to be published

7. 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

8. 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

9. EMACOLEX, May 2011 Thank you