Transcription of Note for guidance on minimising the risk of transmitting ...
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IV (Notices) NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES EUROPEAN COMMISSION Note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products (EMA/410/01 ) (2011/C 73/01) This note provides guidance for minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products. This 3rd technical revision of the TSE (Transmissible Spongiform Encephalopathy) Note for guidance has been undertaken to take into account advancement of science in the area of transmissible spongiform encephalopathies, as well as the evolving situation regarding Bovine Spongiform Encephalopathy (B)
across the world. For the classification of countries or regions according to their BSE risk, the revised Note for Guidance will make reference to the rules laid down by the World Organisation for Animal Health (OIE), replacing the previous GBR classification. Nevertheless, for countries that were classified according to the GBR criteria but
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