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The Certificate has been withdrawn, withdrawn date is : 2024-06-04

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Federal Agency For Medicines And Health Products

CERTIFICATE NUMBER: BE/GMP/2021/161

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER

Part 1

The competent authority of Belgium confirms the following:

The manufacturer: Telix Innovations

Site address:

Rue De Hermee 255, Herstal, 4040

OMS Organisation Id. / OMS Location Id.: ORG-100022029 / LOC-100049862

DUNS Number: 37-076-5512

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. 1889 IMP in accordance with Art. 13 of Directive 2001/20/EC, transposed in the following national legislation:Article 24 from the Law of 7th May 2004 related to the experiments on the humans.

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2021-10-27 , 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

2 IMPORTATION OF MEDICINAL PRODUCTS

2.3 Other importation activities

2.3.2 Importation of intermediate which undergoes further processing

Clarifying remarks (for public users):

The authorization concerns kits (cold kit) allowing radioactive labelling with a radionuclide in order to obtain the final radiopharmaceutical drug. 2.3.2 Import of the intermediate which undergoes further processing: PSMA-11 vials, buffer solution vials and vacuum labeling vials

Withdrawal comments in English: error

Withdrawal comments in National Language: error

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