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The Certificate has been withdrawn, withdrawn date is : 2025-09-08

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Landesamt Fuer Soziale Dienste Schleswig Holstein

CERTIFICATE NUMBER: DE_SH_01_GMP_2024_0042

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 Germany confirms the following:

The manufacturer: Ferring GmbH

Site address:

Wittland 11, Hasseldieksdamm, Kiel, Schleswig-Holstein, 24109

OMS Organisation Id. / OMS Location Id.: ORG-100000599 / LOC-100004313

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. DE_SH_01_MIA_2021_0020 in accordance with 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).

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2021-09-10 , 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:
                   7  Other: Hormones or substances with hormonal activity(en)
           1.1.1.4  Small volume liquids
                  Special Requirements:
                   7  Other: Hormones or substances with hormonal activity(en)
           1.1.1.6  Other: Microcapsules(en)
                  Special Requirements:
                   7  Other: Hormones or substances with hormonal activity(en)
   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)
           1.2.1.6  Liquids for internal use
                  Special Requirements:
                   7  Other: Hormones or substances with hormonal activity(en)
   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
                  Special Requirements:
                   7  Other: Human extracted sterile products -Lyophilisates, aseptically prepared(en)
           1.3.1.8  Other: Sterile products using genetic engineering: - Lyophilisates, aseptically prepared(en)

1.5 Packaging

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
           2.2.3.6  Human or animal extracted products

2.3 Other importation activities

2.3.4 Other: Other Active Pharmaceutical Ingredients produced using genetic engineering: - Somatropin, recombinant human growth hormone (E.coli), lyophilisate - rFSH recombinant human follicle stimulating hormone, solution Active Pharmaceutical Ingredients of human origin: - Menotropin, dry substance - Menotropin HP, dry substance - Urofollitropin, dry substance - Urofollitropin HP, dry substance - Chorionic Gonadotropin, dry substance - Chorionic Gonadotropin HP, dry substance(en)

Any restrictions related to the scope of this certificate:

Building	Room	Line/equipment	QC testing	Products
*Teile der Betriebsstaette befinden sich unter der Adresse Wittland 2, 4-6, 24109 Kiel*			*Zu 1.6.4 und 2.64 Biologisch: ELISA-Test auf bakterielle Endotoxine*

Clarifying remarks (for public users):

Following a risk-based review of GMP compliance information conducted on 25th of November 2024, the validity period of this certificate is extended to 9th of September 2025. To 1.3.1.6 Human or animal extracted products: Human extracted sterile products: - Lyophilisates, aseptically prepared Any restrictions or clarifying remarks related to the scope of these Importation operations: To 2.2.1 Sterile products 2.2.1.1 Aseptically prepared - Lyophilisates - Small volume liquids - Microcapsules 2.2.1.2 Terminally sterilised - Small volume liquids 2.2.2 Non-sterile products - Capsules, hard shell - Liquids for internal use - Other solid forms: Sachets, Granulate - Semi-solids - Suppositories - Tablets - Transdermal patches

Withdrawal comments in English: GMP certificate has been superseded by document with the number DE_SH_01_GMP_2025_0037

Withdrawal comments in National Language: Das GMP-Zertifikat wurde ersetzt durch das Dokument mit der Nummer DE_SH_01_GMP_2025_0037

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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.