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Published: 1-Mar-2006


The European Medicines Agency (EMEA) has received its first market approval application for a pandemic influenza vaccine using an administrative system based on 'mock-up' drugs developed before a strain has been identified. The system, here being used by GlaxoSmithKline Biologicals, allows a 'core dossier' to be approved in advance and to be amended following an outbreak.

Details on 2006 fee reductions for EU market approvals for orphan medicinal products have been issued by the EMEA. The Agency is also asking for feedback on guidance regarding new therapeutic indications for well-established substances.

The Foreign Ministry of Uzbekistan has announced plans to set up a centre to tackle counterfeit drugs trafficking in Kazakhstan.

Roche has won control of http://www.tamiflu-vaccine.com under a ruling by arbitrators for the World Intellectual Property Organisation. The Swiss company had complained that the site, which was promoting and selling face masks as protection against bird flu, infringed its Tamiflu trademark rights.

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