The Committeee for Veterinary Medicinal Products, CVMP at the Europoean Medicines Agency (EMA) follows a request by the Paul-Ehrlich-Institut relating to 'Blood Sweating of Calves'

Following a request by the Paul-Ehrlich-Institut (PEI), the Committee for Medicinal Products for Veterinary Use (CVMP) at the European Medicines Agency (EMA) addressed the increased occurrence of bovine neonatal pancytopenia (BNP, "blood sweating in calves") in May 2010. On Friday, 16 July 2010, the CVMP recommended that the marketing authorisation for Pregsure BVD by Pfizer GmbH should be suspended.

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Harmonized authorisation by competent authorities of clinical trials in three or more EU member states after submission of a single application file

Since 2 March 2010, a modified Voluntary Harmonisation Procedure (VHP) for all clinical trials of medicinal products can be used. A single application submitted to the Clinical Trials Facilitation Group (CTFG) in English will be evaluated in a single procedure together by the competent authorities of those Member States where the clinical trial will be carried out.

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Annual Report published

The Annual Report 2007/2008 is available as a pdf-file for download. Beside the performance of those years the report provides an overview of the national and international work and research at the Paul-Ehrlich-Institut and its significance for vaccines and biomedicines.

A printed version will follow soon.

PEI Annual Report 2007 - 2008 (pdf, 3795 KB)