1 / 9

Recent activities of the HMA/EMA Transparency Group

Recent activities of the HMA/EMA Transparency Group. Tina Engraff Legal Adviser, Danish Medicines Agency. Background & purpose Membership Outcomes Current activities Future activities. Background and purpose. New transparency provision in the Review 2001

mura
Download Presentation

Recent activities of the HMA/EMA Transparency Group

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

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

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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. Thank you Thank you EMACOLEX, May 2011

More Related