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Institute For Standardization And Control Of Pharmaceuticals

CERTIFICATE NUMBER: 16/9

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: Omrix Biopharmaceuticals Ltd.

Site address:

Sheba Medical Center, Mda Blood Bank, Ramat Gan, 5262000, Israel

OMS Organisation Id. / OMS Location Id.: ORG-100011722 / LOC-100019523

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2024-01-25 , 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

1.1 Sterile products

   1.1.1  Aseptically prepared (processing operations for the following dosage forms)
           1.1.1.2  Lyophilisates
           1.1.1.4  Small volume liquids
   1.1.3  Batch certification

1.3 Biological medicinal products (list of product types)

   1.3.1  Biological medicinal products (list of product types)
           1.3.1.1  Blood products
           1.3.1.2  Immunological products
   1.3.2  Batch Certification (list of product types)
           1.3.2.1  Blood products
           1.3.2.2  Immunological products

1.5 Packaging

   1.5.1  Primary Packaging
           1.5.1.6  Liquids for internal use
           1.5.1.8  Other solid dosage forms
   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

2 IMPORTATION OF MEDICINAL PRODUCTS

2.2 Batch certification of imported medicinal products

   2.2.1  Sterile products
           2.2.1.1  Aseptically prepared
           2.2.1.2  Terminally sterilised
   2.2.3  Biological medicinal products
           2.2.3.1  Blood products

4. Other Activities - Active Substances:
3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES Active Substance(s): 3.2 Extraction of Active Substance from Natural Sources 3.2.3 Extraction of substance from human source 3.2.6 Purification of extracted substance 3.3 Manufacture of Active Substance using Biological Processes 3.3.3 Isolation / purification 3.5 General Finishing Steps 3.5.2 Primary packaging 3.5.3 Secondary packaging 3.6 Quality Control Testing 3.6.1 Physical / chemical testing 3.6.2 Microbiological testing (excluding sterility testing) 3.6.3 Microbiological testing (including sterility testing) 3.6.4 Biological Testing

Clarifying remarks (for public users):

►Omrix PFI manufactures Omrigam DP for the local market ►Thrombin liquid DS manufactured by PFI is used for the manufacturing of Evarrest DP at Omrix Ness Ziona facility. It can also be sent for lyophilization at Patheon (Italy) for abroad markets ►Fibrinogen (BAC 2) liquid DS manufactured by PFI is used for the manufacturing of Evarrest DP at Omrix Ness Ziona facility ►Veraseal is manufactured by Grifols (Spain) and imported and marketed in Israel by Omrix (via its contract distributer by Salomon Levin and Elstein (S.L.E) Ltd.) This GMP certificate includes the new distribution warehouse of Omrigam finished products, that was erected on January 2025 ; The site's products are not included in the CAA Agreement between the EU and Israel

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.