edbnp FuropfanDiiKlcrale i Direction eiiropeenne for Ihe Quality !de la quality ofMedones idu medicament & Healthcare <& wins de same Certification of Substances Department 11 THIS CERTIFICATE SUPERSEDES THE PREVIOUS CERTIFICATE 13 After examination of the information provided on the origin of raw material(s) and type of tissue(s) 14 used and on the manufacturing process for this substance on the site(s) of production mentioned 15 above, we certify that the substance CALF SERUM meets the criteria described in the current 16 version of the monograph Products with risk of transmitting agents of animal spongiform 17 encephalopathies no. 1483 of the European Pharmacopoeia, current edition including supplements. 18 - Country of origin of source materials: 20 - Nature of animal tissues used in manufacture: 22 The submitted dossier must be updated after any significant change that may alter the quality, 23 safety or efficacy of the substance, or that may alter the risk of transmitting animal spongiform Manufacture of the substance shall take place in accordance with a suitable quality assurance system, and in accordance with the dossier submitted. Failure to comply with these provisions will render this certificate void. The certificate is valid provided that there has been no deterioration in the TSE status of the country(ies) of origin of the source material. Address: 7 Allee Kastner, CS 30026 F-67081 Strasbourg (France)

This certificate is renewed from 8 August 2021 according to the provisions of Resolution AP-CSP (07) 1, and of Directive 2001/83/EC and Directive 2001/82/EC and any subsequent amendment, and the related guidelines. DECLARATION OF ACCESS (to be filled in by the certificate holder under their own responsibility) BIO WEST SAS, as holder of the certificate of suitability Rl-CEP 2016-162-Rev 00 for Calf Serum hereby authorises {name of the pharmaceutical company) to use the above-mentioned certificate of suitability in support of their application(s) for the following Marketing Authorisation(s): (name...