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The Certificate has been invalidated, invalidated date is : 2024-05-13

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Italian Medicines Agency

CERTIFICATE NUMBER: IT/52/H/2024

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER

Part 1

The competent authority of Italy confirms the following:

The manufacturer: Janssen Cilag S.p.A.

Site address:

Loc Borgo San Michele, Via Carlo Janssen Snc, Latina, 04100, Italy

OMS Organisation Id. / OMS Location Id.: ORG-100000427 / LOC-100000508

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. aAMM55/2024 in accordance with Art. 40 of Directive 2001/83/EC.

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2022-01-27 , 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 Medicinal Products

1 MANUFACTURING OPERATIONS

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
           1.2.1.13  Tablets
   1.2.2  Batch certification

1.5 Packaging

   1.5.1  Primary Packaging
           1.5.1.1  Capsules, hard shell
           1.5.1.13  Tablets
   1.5.2  Secondary packaging

1.6 Quality control testing

1.6.2 Microbiological: non-sterility
1.6.3 Chemical/Physical

2 IMPORTATION OF MEDICINAL PRODUCTS

2.1 Quality control testing of imported medicinal products

2.1.2 Microbiological: non-sterility
2.1.3 Chemical/Physical

2.2 Batch certification of imported medicinal products

2.2.2 Non-sterile products

2.3 Other importation activities

2.3.2 Importation of intermediate which undergoes further processing

Clarifying remarks (for public users):

1.5.1.13 Tablets: also hormones or substances with hormonal activities, also cytostatics; 2.3.2 Importation of intermediate which undergoes further processing: primary and secondary packaging of tablets and capsules imported in bulk, secondary packaging of tablets imported in blister and bottles.

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