Becoming official on 1 July, the EP monograph 5.2.8. "MINIMISING THE RISK OF TRANSMITTING ANIMAL SPONGIFORM ENCEPHALOPATHY AGENTS VIA HUMAN AND VETERINARY MEDICINAL PRODUCTS" was revised. This 3rd technical revision 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 (BSE) across the world. It is identical with the EMA Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products - Revision 3 (EMA/410/01 rev. 3) which becomes official on 1 July too.
For the classification of countries or regions according to their BSE risk, the revised chapter 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 not yet according to the OIE criteria, the existing GBR classification should apply, provided that there is no evidence of significant change in their BSE risk.
New criteria for the sourcing and processing of gelatin and bovine blood derivatives used in the manufacture of medicinal products for human or veterinary use have been introduced, as well as a new subsection on Peptones.
The revised Note for Guidance replaces the previous revision of the Note for Guidance (EMEA/410/01 Rev. 2 published in the Official Journal of the European Union (C 24, 28.1.2004, p. 6)) as the revised chapter replaces the last version, first published in the 5th edition.
Here you can find the changed EP chapter 5.2.8 and the EMA Note for Guidance.
Axel H. Schroeder
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)