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European Medicines Agency finalises guideline on pharmacovigilance for medicines used in children

New procedure agreed for appointment of CHMP rapporteurs/co-rapporteurs

Published 14/07/2006

A new procedure has been agreed for the appointment of rapporteurs, co-rapporteurs and assessment teams involved in the evaluation of marketing authorisation applications submitted to the Committee for Medicinal Products for Human Use (CHMP), as well as in referral procedures. The new procedure will be implemented in September 2006.

Full details of the new procedure are given in the paper ‘CHMP rapporteur/co-rapporteur appointment: principles, objective criteria and methodology’.

Please see the paper here

First live PIM submission reviewed via the centralised procedure

Published 10/07/2006

The first live submission to the product information management (PIM) system was received by the EMEA in support of a new marketing authorisation application via the centralised procedure in June 2006, with a start date for the review procedure of 21 June.

The EMEA, Rapporteur and Co-Rapporteur have committed to the use of the PIM review system for all comments and changes to the product information submitted during the lifecycle of the product.

For more information on PIM, please see the PIM website

Latest Press Releases...
21/07/06	EMEA	Press release EMEA adopts positive opinion for avian influenza vaccines for use in birds
21/07/06	CVMP	Press Release from the July Plenary session
18/07/06	HMPC	Public Statement on Herbal Medicinal Products containing Cimicifugae Racemosae Rhizoma (Black Cohosh, Root) - serious Hepatic reactions
18/07/06	COMP	Press Release from the July Plenary session
12/07/06	CHMP	Monthly Report from the June 2006 Plenary Session
30/06/06	EMEA	Press Release Skye Pharma PLC withdraws its application to extend the marketing authorisation for DepoCyte
14/06/06	HMPC	Meeting Report from the 11-12 May 2006
12/06/06	Management Board	Press Release: EMEA Management Board moves for greater transparency
08/06/06	EMEA	Press Release Pharm Research Associates (UK) Ltd withdraws marketing authorisation application for Surfaxin
06/06/06	CHMP	Press Release European Medicines Agency adopts a positive opinion for the use of Prozac in the treatment of children and adolescents suffering from depression
02/06/06	EMEA	Press Release European Quality Leader of the year 2006' award goes to EMEA staff member
02/06/06	EMEA	Press Release European Medicines Agency adopts first positive opinion for a medicinal product derived from transgenic biotechnology
01/06/06	EMEA	Press Release European Medicines Agency introduces new, faster scientific advice procedure rev 2
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