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The Certificate has been withdrawn, withdrawn date is : 2023-11-22

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Federal Agency For Medicines And Health Products

CERTIFICATE NUMBER: BE/GMP/2023/073

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER

Part 1

The competent authority of BELGIUM confirms the following:

The manufacturer: UCB Pharma

Site address:

Chemin Du Foriest 1, Braine-L'alleud, 1420, Belgium

OMS Organisation Id. / OMS Location Id.: ORG-100000302 / LOC-100001877

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. 194 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 2023-07-07 , 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

1.1.3 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

1.5 Packaging

1.5.2 Secondary packaging

2 IMPORTATION OF MEDICINAL PRODUCTS

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
           2.2.3.5  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

Withdrawal comments in English: Other version exists

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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.