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The Certificate has been invalidated, invalidated date is : 2024-05-15

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Italian Medicines Agency

CERTIFICATE NUMBER: IT/7/H/2024

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER

Part 1

The competent authority of Italy confirms the following:

The manufacturer: Advanced Accelerator Applications (Italy) S.r.l.

Site address:

Via Ribes 5, Colleretto Giacosa, 10010, Italy

OMS Organisation Id. / OMS Location Id.: ORG-100001307 / LOC-100018025

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. aM3/2024 in accordance with Art. 13 of Directive 2001/20/EC.

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2023-10-13 , 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)
           1.1.1.4  Small volume liquids
                  Special Requirements:
                   5  Radiopharmaceuticals
   1.1.3  Batch certification

1.5 Packaging

1.5.2 Secondary packaging

1.6 Quality control testing

1.6.3 Chemical/Physical
1.6.4 Biological

2 IMPORTATION OF MEDICINAL PRODUCTS

2.1 Quality control testing of imported medicinal products

2.1.3 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

2.3 Other importation activities

2.3.1 Site of physical importation

Clarifying remarks (for public users):

1.1.1.4 Small volume liquids: Radiopharmaceuticals labelled with 177Lu; 1.1.3 Batch certification: Only aseptically prepared radiopharmaceuticals; 1.5.2 Secondary packing: only radiopharmaceuticals; 1.6.3 Chemical/Physical: only radiopharmaceuticals; 1.6.4 Biological: only radiopharmaceuticals; 2.1.3 Chemical/Physical: only radiopharmaceuticals, (177Lu)Lu-PSMA; 2.1.4 Biological: LAL test (endotoxins test). Only radiopharmaceuticals, (177Lu)Lu-PSMA; 2.2.1.1 Aseptically prepared products : only radiopharmaceuticals, (177Lu)Lu-PSMA; 2.3.1 Site of physical importation: only radiopharmaceuticals, (177Lu)Lu-PSMA.

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