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The Certificate has been invalidated, invalidated date is : 2026-04-29

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Italian Medicines Agency

CERTIFICATE NUMBER: IT/12/H/2026

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER(1) , (2)

Part 1

Issued following an inspection in accordance with
Art. 111(5) of Directive 2001/83/EC as amended

The competent authority of Italy confirms the following:

The manufacturer: Mitim S.r.l.

Site address:

Via Giovanni Battista Cacciamali 34-38, Brescia, 25125, Italy

OMS Organisation Id. / OMS Location Id.: ORG-100004827 / LOC-100007766

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. aM-9/2026 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 2023-05-18 , it is considered that it complies with:

The principles and guidelines of Good Manufacturing Practice laid down in Directive (EU) 2017/1572. (3)

This certificate reflects the status of the manufacturing site at the time of the inspection noted above and should not be relied upon to reflect the compliance status if more than three years have elapsed since the date of that inspection. However, this period of validity may be reduced or extended using regulatory risk management principles by an entry in the Restrictions or Clarifying remarks field. Updates to restrictions or clarifying remarks can be identified through the EudraGMDP website (https://eudragmdp.ema.europa.eu/). This certificate is valid only when presented with all pages and both Parts 1 and 2.

The authenticity of this certificate may be verified in EudraGMDP. If it does not appear, please contact the issuing authority.

__________________________________________________________________________________________________________________________

(1) The certificate referred to in paragraph Art. 111(5) of Directive 2001/83/ECis also applicable to importers.
(2) Guidance on the interpretation of this template can be found in the Interpretation of the Union format for GMP certificate.
(3) These requirements fulfil the GMP recommendations of WHO.

Part 2

Human 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:
                   1  B-lactam Antibiotics
           1.1.1.6  Other: Powders(en)
                  Special Requirements:
                   1  B-lactam Antibiotics
   1.1.2  Terminally Sterilised (processing operations for the following dosage forms)
           1.1.2.3  Small volume liquids
   1.1.3  Batch certification

1.2 Non-sterile products

   1.2.1  Non-sterile products (processing operations for the following dosage forms)
           1.2.1.1  Capsules, hard shell
                  Special Requirements:
                   1  B-lactam Antibiotics
           1.2.1.8  Other solid dosage forms: Powders(en)
                  Special Requirements:
                   1  B-lactam Antibiotics
           1.2.1.13  Tablets
                  Special Requirements:
                   1  B-lactam Antibiotics
   1.2.2  Batch certification

1.3 Biological medicinal products (list of product types)

   1.3.1  Biological medicinal products (list of product types)
           1.3.1.6  Human or animal extracted products
   1.3.2  Batch Certification (list of product types)
           1.3.2.6  Human or animal extracted products

1.5 Packaging

   1.5.1  Primary Packaging
           1.5.1.1  Capsules, hard shell
                  Special Requirements:
                   1  B-lactam Antibiotics
           1.5.1.8  Other solid dosage forms: Powders(en)
                  Special Requirements:
                   1  B-lactam Antibiotics
           1.5.1.13  Tablets
                  Special Requirements:
                   1  B-lactam Antibiotics
   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
   2.1.3  Chemical/Physical
   2.1.4  Biological

2.3 Other importation activities

2.3.1 Site of physical importation
2.3.2 Importation of intermediate which undergoes further processing

Any restrictions related to the scope of this certificate:

Building	Room	Line/equipment	QC testing	Products
*MAGAZZINO -VIA SERPENTE, 79 -25125 -BRESCIA (BS)*		*1.4.3 Others: storage*

Clarifying remarks (for public users):

1.1.1.2 Lyophilisates: penicillins and cephalosporine - only filling; 1.1.1.6 Other aseptically prepared products (powders): penicillins and cephalosporines - only filling; 1.1.2.3 Small volume liquids: also animal extracted products; 1.2.1.1 Capsules, hard shell: only penicillins; 1.2.1.8 Other solid dosage forms: powders;only penicillins; 1.2.1.13 Tablets: only penicillins; 1.3.1.6 Human or animal extracted products: Medicinal products containing, derived or extracted from animal tissue/cells; 1.5.1.1 Capsules, hard shell: only penicillins; 1.5.1.8 Other solid dosage forms: powders; only penicillins; 1.5.1.13 Tablets: only penicillins; 1.6.4 Biological: LAL test; 2.1.4 Biological: Bacterial endotoxins; 2.3.2 Importation of intermediate which undergoes further processing: sterile lyophilized bulk product based on beta-lactam antibiotics - Penicillins, and sterile bulk powder based on beta-lactam antibiotics - Cephalosporins, subjected to primary and secondary packaging.

The EudraGMDP database is maintained and operated by the EMA. Access to the general public is granted in order to enhance availability of information related to the EMA mandate. The content of the database is provided by the National Competent Authorities (NCA) of the EEA. For this reason, the EMA accepts no responsibility or liability whatsoever (including but not limited to any direct or consequential loss or damage it might occur to you and/or any other third party) arising out of or in connection with the information on this database. Any questions about the content should be addressed to the relevant NCA. Please click here to get list of NCA's.

For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.

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.