European Owettorate [ Dmtoi europeenrw for the Quality delaquaSt* ofMedkirwt du midkament & HeaWiCare I & soins <te unt* Certification of Substances Department Avenida Copacabana 177, Salal24 Empresarial 18 Do Forte Barueri Brazil-06472-001 Sao Paulo THIS CERTIFICATE SUPERSEDES THE PREVIOUS CERTIFICATE Rl-CEP 2007-074 - REV 02 After examination of the information provided on the origin of raw material(s) and type of tissue(s) used and on the manufacturing process for this substance on the site(s) of production mentioned above, we certify that the substance FOETAL BOVINE SERUM meets the criteria described in the current version of the monograph Products with risk of transmitting agents of animal spongiform encephalopathies no. 1483 of the European Pharmacopoeia, current edition including supplements. - Countries of origin of source materials: Argentina, Brazil, Chile, Colombia, Costa Rica, Denmark, France, Ireland, Italy, Mexico, Panama, Paraguay, Spain, United States of America and Uruguay - Nature of animal tissues used in manufacture: Foetal bovine blood The submitted dossier must be updated after any significant change that may alter the quality, safety or efficacy of the substance, or that may alter the risk of transmitting animal spongiform encephalopathy agents. Address: 7 Allee Kastner, CS 30026 F-67081 Strasbourg (France)

30 Manufacture of the substance shall take place in accordance with a suitable quality assurance 31 system, and in accordance with the dossier submitted. 32 Failure to comply with these provisions will render this certificate void. 33 The certificate is valid provided that there has been no deterioration in the TSE status of the 34 country(ies) of origin of the source material. 35 This certificate is renewed from 18 January 2013 according to the provisions of Resolution 36 AP-CSP (07) 1, and of Directive 2001/83/EC and Directive 2001/82/EC and any subsequent 37 amendment, and the related guidelines....