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Federal Agency For Medicines And Health Products

CERTIFICATE NUMBER: BE/GMP/2025/047

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

Part 1

Issued following an inspection in accordance with
Art. 63 of Regulation (EU) 536/2014 as amended

The competent authority of Belgium confirms the following:

The manufacturer: Janssen Pharmaceutica

Manufacturer's alternative name: Janssen Pharmaceutica N.V.

Site address:	Turnhoutseweg 30, Beerse, 2340, Belgium
Additional details on units inspected:	*Eenheid Beerse – R&D*

OMS Organisation Id. / OMS Location Id.: ORG-100000625 / LOC-100005958

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. 2 IMP in accordance with Art. 61 of Regulation (EU) No 536/2014.

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2025-04-30 , 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)

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. 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 Investigational Medicinal Products

1 MANUFACTURING OPERATIONS

1.1 Sterile products

   1.1.1  Aseptically prepared (processing operations for the following dosage forms)
           1.1.1.4  Small volume liquids
   1.1.2  Terminally Sterilised (processing operations for the following dosage forms)
           1.1.2.3  Small volume liquids
   1.1.3  Batch certification

1.2 Non-sterile products

   1.2.1  Non-sterile products (processing operations for the following dosage forms)
           1.2.1.1  Capsules, hard shell
           1.2.1.5  Liquids for external use
           1.2.1.6  Liquids for internal use
           1.2.1.8  Other solid dosage forms: powders and granulates(en)
           1.2.1.13  Tablets
           1.2.1.14  Transdermal patches
   1.2.2  Batch certification

1.3 Biological medicinal products (list of product types)

   1.3.1  Biological medicinal products (list of product types)
           1.3.1.2  Immunological products
           1.3.1.5  Biotechnology products
   1.3.2  Batch Certification (list of product types)
           1.3.2.2  Immunological products
           1.3.2.3  Cell therapy products
           1.3.2.5  Biotechnology products

1.4 Other products or manufacturing activity

1.4.1 Manufacture of
1.4.1.3 Other: Challenging agents, limited to packaging and batch certification(en)

1.5 Packaging

   1.5.1  Primary Packaging
           1.5.1.1  Capsules, hard shell
           1.5.1.5  Liquids for external use
           1.5.1.6  Liquids for internal use
           1.5.1.8  Other solid dosage forms
           1.5.1.13  Tablets
           1.5.1.14  Transdermal patches
   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

2.1 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

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
   2.2.2  Non-sterile products
   2.2.3  Biological medicinal products
           2.2.3.1  Blood products
           2.2.3.2  Immunological products
           2.2.3.3  Cell therapy products
           2.2.3.4  Gene therapy products
           2.2.3.5  Biotechnology products

2.3 Other importation activities

   2.3.1  Site of physical importation
   2.3.2  Importation of intermediate which undergoes further processing
   2.3.3  Biological active substance
   2.3.4  Other: Challenging agents(en)

Clarifying remarks (for public users):

1.1.3: Batch certification of sterile products, including radio-labelled products 1.3.1.2: Limited to thawing, mixing and filling of externally manufactured bulk solutions 1.3.1.5: Limited to formulation and filling 2.3.2: Partially produced biotechnology products, granulates, powders, non-coated tablets

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.