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The Certificate has been withdrawn, withdrawn date is : 2024-07-10

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Federal Agency For Medicines And Health Products

CERTIFICATE NUMBER: BE/GMP/2024/040

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER

Part 1

The competent authority of Belgium confirms the following:

The manufacturer: Pfizer Manufacturing Belgium

Site address:

Rijksweg 12, Puurs-Sint-Amands, 2870, Belgium

OMS Organisation Id. / OMS Location Id.: ORG-100005177 / LOC-100002937

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. 277 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 2024-03-21 , 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 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
                  Special Requirements:
                   7  Other: certain hormones(en)
           1.1.1.4  Small volume liquids
                  Special Requirements:
                   7  Other: certain hormones(en)
   1.1.2  Terminally Sterilised (processing operations for the following dosage forms)
           1.1.2.3  Small volume liquids
   1.1.3  Batch certification

1.3 Biological medicinal products (list of product types)

   1.3.1  Biological medicinal products (list of product types)
           1.3.1.2  Immunological products
                  Special Requirements:
                   7  Other: formulation and filling only(en)
           1.3.1.5  Biotechnology products
                  Special Requirements:
                   7  Other: formulation and filling only(en)
           1.3.1.6  Human or animal extracted products
                  Special Requirements:
                   7  Other: formulation and filling only and special requirement low molecular weight heparine(en)
   1.3.2  Batch Certification (list of product types)
           1.3.2.2  Immunological products
           1.3.2.5  Biotechnology products
           1.3.2.6  Human or animal extracted products

1.4 Other products or manufacturing activity

1.4.3 Other: Storage(en)

1.5 Packaging

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

Withdrawal comments in English: nok

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