European Medicines Agency

Draft policy on access to EMEA documents released for public consultation		New ENCePP website launched
Published 22/12/2008		Published 22/12/2008
As part of its continuing efforts to ensure transparency of its operations, the European Medicines Agency (EMEA) has today published a draft policy on practical measures to uphold EU citizens’ rights to the widest possible access to documents held by the EMEA. Comments on the draft policy may be submitted until 2 March 2009, by e-mail to: documents.access@emea.europa.eu		A new website, hosted by the European Medicines Agency, has been launched today to inform EMEA partners and the public about the work of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) — a network set up to strengthen the monitoring of authorised medicines in the European Union.
For full details see: Draft policy on the practical operation of access to EMEA documents		For full details, visit the ENCePP website

EMEA draft policy on access to EudraVigilance released for public consultation		New ‘Medicines for the elderly’ section of the EMEA website
Published 22/12/2008		Published 17/12/2008
EudraVigilance, the database of adverse reactions relating to medicines authorised for use in the European Union, is a key resource in Europe’s efforts to monitor the safety of approved medicines for human use. In line with EU legislation, the European Medicines Agency (EMEA), in consultation with applicable stakeholders, has drafted a policy that would see information from the database made available to healthcare professionals, patients and pharmaceutical companies, with appropriate measures for the protection of personal data. This draft access policy for EudraVigilance is now available for public consultation until 2 March 2009.		With the proportion of elderly people in society increasing rapidly, it is important to ensure that their special needs are taken into consideration when developing, authorising and using new medicines. Together with its partners in the European Union and in collaboration with other regional regulatory bodies, the European Medicines Agency is working to address those needs, and has created a new section of its website to provide information about ongoing efforts in this area.
Consult the document directly: Draft EudraVigilance access policy See the Regulatory and procedural guidance section of this website		See Medicines for the Elderly

Latest Press Releases		See Press Office for archived press releases
22/12/08	PDCO	Press Release from the 10-12 December meeting Corr.
22/12/08	COMP	Monthly report from the December meeting Corr.2
19/12/08	EMEA	Press Release - Gendux Molecular Limited withdraws its marketing authorisation application for Advexin (contusugene ladenovec)
19/12/08	CHMP	Press Release from the December meeting Corr.
17/12/08	PDCO	Press Release from the 10-12 December meeting
17/12/08	CHMP	Press Release Janssen-Cilag International N.V. withdraws its application for an extension of indication for Invega (paliperidone)
17/12/08	MB	Press Release EMEA Management Board adopts work programme for a busy year ahead and agrees to move towards greater transparency of its meetings
12/12/08	COMP	Monthly report from the December meeting Corr.
12/12/08	CVMP	Press Release from the December Meeting
12/12/08	CVMP	Press Release European Medicines Agency recommends suspension of classical swine fever vaccine Porcilis Pesti
04/12/08	CHMP	Press Release Oncoscience AG withdraws its application for Theraloc (nimotuzumab)
		See Press Office for archived press releases