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Austrian Agency For Health And Food Safety

CERTIFICATE NUMBER: 484296-103675257

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER(1) , (2)

Part 1

Issued following an inspection in accordance with
Art. 111(5) of Directive 2001/83/EC as amended
Art. 94(1) of Regulation (EU) 2019/6 as amended
Art. 63 of Regulation (EU) 536/2014 as amended

The competent authority of Austria confirms the following:

The manufacturer: Novartis Pharmaceutical Manufacturing GmbH

Site address:

Biochemiestrasse 10, Kundl, 6250, Austria

OMS Organisation Id. / OMS Location Id.: ORG-100045162 / LOC-100075588

Other

(Human) API-A123(6)-R2019/6/EU,API-A111(1)-D2001/83/EC,NIP-A40-D2001/83/EC

(Investigational product) NIP-A61-R2014/536/EU

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2025-12-04 , it is considered that it complies with:

The principles and guidelines of Good Manufacturing Practice laid down in Directive (EU) 2017/1572 and/or Commission Delegated Regulation (EU) 2017/1569, as reflected by the product categories stated in Part 2. (3)

The principles and guidelines of Good Manufacturing Practice laid down in Directive 91/412/EEC. (3)

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. However, this period of validity may be reduced or extended using regulatory risk management principles by an entry in the Restrictions or Clarifying remarks field. Updates to restrictions or clarifying remarks can be identified through the EudraGMDP website (https://eudragmdp.ema.europa.eu/). 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.

__________________________________________________________________________________________________________________________

(1) The certificate referred to in paragraph Art. 111(5) of Directive 2001/83/EC, Art. 80(5) of Directive 2001/82/EC and Art. 15 of Directive 2001/20/ECis also applicable to importers.
(2) Guidance on the interpretation of this template can be found in the Interpretation of the Union format for GMP certificate.
(3) These requirements fulfil the GMP recommendations of WHO.

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, 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:

[900000005572]The complete list of APIs that are subject to quality control testing is available to the Austrian Federal Office for Safety in Health Care (BASG/AGES)(en)

[900000005719]Rozanolixizumab (RO192)(en)

3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

Active Substance:The complete list of APIs that are subject to quality control testing is available to the Austrian Federal Office for Safety in Health Care (BASG/AGES)

3.6 Quality Control Testing

3.6.2  Microbiological testing excluding sterility testing

3.6.4  Biological Testing

Active Substance:Rozanolixizumab (RO192)

3.3 Manufacturing of Active Substance using Biological Processes

3.3.1  Fermentation

3.3.2  Cell Culture:
Anzucht von CHO Zellen als WCB / Cultivation of CHO cells as WCB

3.3.3  Isolation / Purification

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)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.2  Microbiological testing excluding sterility testing

Clarifying remarks (for public users):

Hersteller Wirkstoffe: Novartis Pharmaceutical Manufacturing GmbH; 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 follow…; Hersteller klinischer Prüfpräparate: Novartis Pharmaceutical Manufacturing GmbH; 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 follow…; Hersteller Arzneimittel: Novartis Pharmaceutical Manufacturing GmbH; 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 follow…;

Withdrawal comments in English: Superseded because new certificate was issued following an inspection

Withdrawal comments in National Language: Superseded because new certificate was issued following an inspection

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.