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Regierungspraesidium Tuebingen Leitstelle Arzneimittelueberwachung Baden-Wuerttemberg

CERTIFICATE NUMBER: DE_BW_01_GMP_2024_0162

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

Part 1

Issued following an inspection in accordance with
Art. 94(1) of Regulation (EU) 2019/6 as amended

The competent authority of Germany confirms the following:

The manufacturer: Boehringer Ingelheim Pharma GmbH & Co. KG

Site address:

Birkendorfer Straße 65, Biberach An Der Riß, Baden-Württemberg, 88397

OMS Organisation Id. / OMS Location Id.: ORG-100000199 / LOC-100005703

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. DE_BW_01_MIA_2024_0006 in accordance with Art. 88 of Regulation (EU) 2019/6.

Is an active substance manufacturer that has been inspected in accordance with Art. 123(6) of Regulation (EU) 2019/60.

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2024-05-15 , it is considered that it complies with:

The principles and guidelines of Good Manufacturing Practice laid down in Directive 91/412/EEC. (3)

The principles of GMP for active substances referred to in Art. 123(6) of Regulation (EU) 2019/6.

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. 80(5) of Directive 2001/82/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

Veterinary Medicinal Products

1 MANUFACTURING OPERATIONS

1.1 Sterile products

   1.1.1  Aseptically prepared (processing operations for the following dosage forms)
           1.1.1.1  Large volume liquids
           1.1.1.2  Lyophilisates
           1.1.1.4  Small volume liquids
   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
           1.2.1.8  Other solid dosage forms
           1.2.1.13  Tablets
   1.2.2  Batch certification

1.3 Biological medicinal products (list of product types)

   1.3.1  Biological medicinal products (list of product types)
           1.3.1.5  Biotechnology products
   1.3.2  Batch Certification (list of product types)
           1.3.2.5  Biotechnology products

1.4 Other products or manufacturing activity

1.4.1 Manufacture of
1.4.1.3 Other: active pharmaceutical ingredients, biotechnologically manufactured : recombinant proteins monoclonal antibodies cytokines(en)

1.5 Packaging

   1.5.1  Primary Packaging
           1.5.1.1  Capsules, hard shell
           1.5.1.8  Other solid dosage forms
           1.5.1.13  Tablets
   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
   2.1.2  Microbiological: non-sterility
   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
           2.2.1.2  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
2.3.4 Other: active pharmaceutical ingredients, biotechnologically manufactured : recombinant proteins monoclonal antibodies cytokines(en)

Clarifying remarks (for public users):

ad 1.2.1.8 und 1.5.1.8: Other solid dosage forms are powder, granulates, pellets. ad 1.3.1.5: Recombinant proteins/DNA Others monoclonal antibodies cytokines ad 1.4.1.3: Preparation, quality control, storage and release of cell bank to manufacture drug substance are included. ad 2.3.4: Quality control, storage and release of cell bank to manufacture drug substance are included. Authorised manufacturing does NOT cover xenogeneic products, tissue and cell products, medicinal products for use in in-vivo diagnosis by means of marker genes and radiopharmaceuticals.

Withdrawal comments in English: GMP certificate has been superseded by document with the number DE_BW_01_GMP_2024_0170

Withdrawal comments in National Language: Das GMP-Zertifikat wurde ersetzt durch das Dokument mit der Nummer DE_BW_01_GMP_2024_0170

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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.