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The Certificate has been withdrawn, withdrawn date is : 2025-12-19

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Landesamt Fuer Soziales Jugend Und Versorgung

CERTIFICATE NUMBER: DE_RP_01_GMP_2025_0016

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

Part 1

Issued following an inspection in accordance with
Art. 15 of Directive 2001/20/EC as amended
Art. 111(5) of Directive 2001/83/EC as amended

The competent authority of Germany confirms the following:

The manufacturer: Boehringer Ingelheim Pharma GmbH & Co. KG

Site address:

Binger Strasse 173, Ingelheim Am Rhein, Rhineland-Palatinate, 55216

OMS Organisation Id. / OMS Location Id.: ORG-100000199 / LOC-100004370

DUNS Number: 55-114-7440

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. DE_RP_01_MIA_2025_0009 in accordance with Art. 13 of Directive 2001/20/EC and Art. 40 of Directive 2001/83/EC, transposed in the following national legislation:Sect. 13 para 1 German Medicinal Product Act (manufacture) and § 72 German Medicinal Product Act (import) and Sect. 13 para 1 German Medicinal Product Act (manufacture) and § 72 German Medicinal Product Act (import).

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2024-11-20 , it is considered that it complies with:

The principles and guidelines of Good Manufacturing Practice laid down in Directive (EU) 2017/1572 and/or Commission Delegated Regulation (EU) 2017/1569, as reflected by the product categories stated in Part 2. (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. 15 of Directive 2001/20/EC and 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
Human Investigational Medicinal Products

1 MANUFACTURING OPERATIONS

1.1 Sterile products

   1.1.1  Aseptically prepared (processing operations for the following dosage forms)
           1.1.1.6  Other: <Liquids for inhalation>(en)
   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
                  Special Requirements:
                   7  Other: <Powder and granules> <Pellets>(en)
           1.2.1.9  Pressurised preparations
           1.2.1.13  Tablets
           1.2.1.17  Other: <Liquids for inhalation>(en)
   1.2.2  Batch certification

1.5 Packaging

   1.5.1  Primary Packaging
           1.5.1.1  Capsules, hard shell
           1.5.1.2  Capsules, soft shell
           1.5.1.9  Pressurised preparations
           1.5.1.13  Tablets
           1.5.1.17  Other non-sterile medicinal products: <Liquids for inhalation>(en)
   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

   2.1.1  Microbiological: sterility
   2.1.2  Microbiological: non-sterility
   2.1.3  Chemical/Physical

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

Clarifying remarks (for public users):

Batch certification without manufacturing operations: The list in Part 2/1 Manufacturing Operations does not include products / dosage forms for which batch release only takes place. Comments regarding Manufacturing Operations Human Medicinal Products: 1.1 Sterile products 1.1.1.6 Aseptically prepared solutions for inhalation are intended for USA and China. The manufacturing activities take place in the following buildings: 2032A, 2032B, 2032C, 2058, 3165, 3175, 3242, 3259, 3264, 3269, 3371, 3480, 4139, 4313, 4322, 4329, 4435, 4511, 5314, 5411, 5435 and 6365 (see site plan of the factory, Werkgrundkarte, Z. Nr.: ING-30-0000-002-B vom 28.08.24) Comments regarding Manufacturing operations Human Investigational Medicinal Products: 1.1 Sterile Products and 1.2 Non-sterile Products: Batch certification only for Finished Medicinal Products used as comparisons The manufacturing activities take place in the following buildings: 2032A, 3269, 4313, 4322, 4329, 4435, (text missing)

Withdrawal comments in English: GMP certificate has been superseded by document with the number DE_RP_01_GMP_2025_0050

Withdrawal comments in National Language: Das GMP-Zertifikat wurde ersetzt durch das Dokument mit der Nummer DE_RP_01_GMP_2025_0050

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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.