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The Certificate has been invalidated, invalidated date is : 2026-01-08

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Institute For Standardization And Control Of Pharmaceuticals

CERTIFICATE NUMBER: 92/12

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:

Weizmann Science Park, Floor First, 14, Einstein Street, Ness Ziona, 7403618, Israel

OMS Organisation Id. / OMS Location Id.: ORG-100011722 / LOC-100021306

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2024-01-11 , 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)
           1.3.1.1  Blood products
   1.3.2  Batch Certification (list of product types)
           1.3.2.1  Blood products

1.4 Other products or manufacturing activity

   1.4.2  Sterilisation of active substance/ excipients/ finished product
           1.4.2.1  Filtration
           1.4.2.6  Electron beam

1.5 Packaging

   1.5.1  Primary Packaging
           1.5.1.8  Other solid dosage forms: Fibrin patches(en)
   1.5.2  Secondary packaging

1.6 Quality control testing

   1.6.1  Microbiological: sterility
   1.6.3  Chemical/Physical
   1.6.4  Biological

Clarifying remarks (for public users):

The plant manufactures Fibrin Sealant Patch (EVARREST®), a terminally sterilized plasma derived product (Fibrin Sealant Patch consists of human Fibrinogen and human Thrombin embedded in a flexible composite patch component (matrix) ● The manufacturing facility of the matrix is also located at NZ campus. The matrix is a medical device ● The sterilzation of the patches, the sterility testing and some chemical / physical and biological testing are outsourced ● Blood products are not included in the ACAA 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.