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Austrian Agency For Health And Food Safety

CERTIFICATE NUMBER: 484296-101956741

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER

Part 1

The competent authority of AUSTRIA confirms the following:

The manufacturer: Novartis Pharmaceutical Manufacturing GmbH

Site address:

Biochemiestrasse 10, Unterlangkampfen, Langkampfen, Tirol, 6336, Austria

OMS Organisation Id. / OMS Location Id.: ORG-100045162 / LOC-100074523

Is an active substance manufacturer that has been inspected in accordance with Art. 111(1) of Directive 2001/83/EC1 transposed in the following national legislation:§ 63a Medicines Act (Arzneimittelgesetz) and Ordinance 2009 (Arzneimittelbetriebsordnung 2009).

Other

(Human) Art. 40 of Directive 2001/83/EC

(Veterinary) Art. 88 of Regulation (EU) 2019/6

(Investigational product) Art. 13 of Directive 2001/20/EC

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2023-02-15 , it is considered that it complies with:

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
Veterinary Medicinal Products

1 MANUFACTURING OPERATIONS

1.1 Sterile products

1.1.3 Batch certification

1.2 Non-sterile products

1.2.2 Batch certification

1.3 Biological medicinal products (list of product types)

1.3.2 Batch Certification (list of product types)
1.3.2.5 Biotechnology products

1.4 Other products or manufacturing activity

1.4.3 Other: Herstellung nicht steriler wässriger Plasmid Lösungen aus bakterieller Fermentation (E. coli Zellen) / Manufacture of non-sterile aqueous plasmid solutions by bacterial fermentation (E. coli cells); Herstellung von RNA Impfstoff (CV2 mRNA) und intermediate Bulk / Manufacture of RNA vaccine (CV2 mRNA) and intermediate bulk; Herstellung von Master Cell Banks (MCB) und / oder Working Cell Banks (WCB) / Manufacture of master cell banks and / or working cell banks(en)

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

2.1 Quality control testing of imported medicinal products

   2.1.1  Microbiological: sterility
   2.1.2  Microbiological: non-sterility
   2.1.3  Chemical/Physical
   2.1.4  Biological

Manufacture of active substance. Names of substances subject to inspection:

[AGES_BASG]THE COMPLETE LIST OF MANUFACTURED / DISTRIBUTED ACTIVE SUBSTANCES IS AVAILABLE AT THE INSTITUTE SURVEILLANCE(en)

3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

Active Substance:THE COMPLETE LIST OF MANUFACTURED / DISTRIBUTED ACTIVE SUBSTANCES IS AVAILABLE AT THE INSTITUTE SURVEILLANCE

3.3 Manufacturing of Active Substance using Biological Processes

3.3.1  Fermentation

3.3.3  Isolation / Purification

3.3.4  Modification

3.3.5  Other:
-

3.5 General Finishing Steps

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.5.4  Other:
-

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.2  Microbiological testing excluding sterility testing

3.6.4  Biological Testing

Clarifying remarks (for public users):

Einschließlich Lagerung von Master- und/oder Working Cell Banks / including storage of master cell banks and/or working cell banks Probebetrieb betreffend folgende Verfahren gültig bis / Regarding the following inspection cases valid until 12/2026: INS-484296-101532805 INS-484296-101956741

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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.