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Institute For Standardization And Control Of Pharmaceuticals

CERTIFICATE NUMBER: 258/4

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER

Part 1

Issued under the provisions of the Agreement on Conformity Assessment and Acceptance of industrial products (ACAA) between the European Union and Israel

The competent authority of Israel confirms the following:

The manufacturer: Gamida Cell Ltd.

Site address:

12, Leshem, Kiryat Gat, 8258412, Israel

OMS Organisation Id. / OMS Location Id.: ORG-100006317 / LOC-100087249

DUNS Number: 62-649-9978

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2022-12-01 , it is considered that it complies with: The Good Manufacturing Practice requirements referred to in the Agreement on Conformity Assessment and Acceptance of industrial products (ACAA) between the European Union and Israel

This certificate reflects the status of the manufacturing site at the time of the inspection noted above and should not be relied upon to reflect the compliance status if more than three years have elapsed since the date of that inspection. This certificate is valid only when presented with all pages and both Parts 1 and 2.

The authenticity of this certificate may be verified in EudraGMDP. If it does not appear, please contact the issuing authority.

Part 2

Human Medicinal Products
Human Investigational Medicinal Products

1 MANUFACTURING OPERATIONS

1.3 Biological medicinal products (list of product types)

   1.3.1  Biological medicinal products (list of product types)
           1.3.1.3  Cell therapy products
   1.3.2  Batch Certification (list of product types)
           1.3.2.3  Cell therapy products

1.5 Packaging

1.5.2 Secondary packaging

1.6 Quality control testing

   1.6.1  Microbiological: sterility
   1.6.2  Microbiological: non-sterility
   1.6.3  Chemical/Physical
   1.6.4  Biological

Clarifying remarks (for public users):

The plant manufactures OMISIRGE (omidubicel-onlv) allogeneic cell therapy derived from Cord Blood ● Nicotinamide is dispensed before the sterile filtration by a contract manufacturer, Nextar Chempharma Solutions Ltd., located at 13-B Einstein St., Weizmann Science Park, Ness Ziona, Israel ● The microbiological tests and some chemical / physical tests are outsourced ● Regardind the IMPs : this GMP certificate is relevant to IMPs for phase III clinical trials ● Cell therapy products and IMPs are not included in the EU- Israeli CAA agreement

The EudraGMDP database is maintained and operated by the EMA. Access to the general public is granted in order to enhance availability of information related to the EMA mandate. The content of the database is provided by the National Competent Authorities (NCA) of the EEA. For this reason, the EMA accepts no responsibility or liability whatsoever (including but not limited to any direct or consequential loss or damage it might occur to you and/or any other third party) arising out of or in connection with the information on this database. Any questions about the content should be addressed to the relevant NCA. Please click here to get list of NCA's.

For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.

Documents issued by UK authorities up to and including 31 December 2020 remain available for consultation in EudraGMDP. However, they are no longer included or updated from 1 January 2021, with the exception of the documents pertaining to sites located in Northern Ireland.