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The Certificate has been withdrawn, withdrawn date is : 2024-06-25

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Bezirksregierung Arnsberg

CERTIFICATE NUMBER: DE_NW_01_GMP_2023_0015

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: Bayer AG

Site address:

Ernst-Schering-Strasse 14, Bergkamen, North Rhine-Westphalia, 59192, Germany

OMS Organisation Id. / OMS Location Id.: ORG-100000011 / LOC-100017510

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. DE_NW_01_MIA_2022_0029 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).

Is an active substance manufacturer that has been inspected in accordance with Art. 111(1) of Directive 2001/83/EC1 transposed in the following national legislation:Sect. 64 para 1 and 3 German Medicinal Product Act.

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2022-08-16 , 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)

The principles of GMP for active substances referred to in Article 47 of Directive 2001/83/EC and an appropriate level of GMP as referred to in Article 46(f) of Directive 2001/83/EC transposed in the following national legislation:Sect. 64 para 1 and 3 German Medicinal Product Act.

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

1.4 Other products or manufacturing activity

1.4.1 Manufacture of
1.4.1.3 Other: - active pharmaceutical ingredients (API) that fall into the scope of SECT. 13 Abs. 1 AMG - APIs that do not fall into the scope of SECT. 13 Abs. 1 AMG (chemical synthesis)(en)

1.6 Quality control testing

1.6.2 Microbiological: non-sterility
1.6.3 Chemical/Physical

Clarifying remarks (for public users):

Manufacture of active substance. Names of substances subject to inspection: 1.Asundexian 3) 2.Acelaic acid 3.Calcium butrol 4.Chlorquinaldol 1) 5.Cinchocaine hydrochloride 1) 6.Cyproterone acetate 7.Dienogest 8.Diflucortolone valerate 9.Drospirenone 10.Elinzanetant 11.EOB-DTPA 12.Estradiol hemihydrate 13.Estradiol valerate 14.Ethinyl estradiol 15.Ethinyl estradiol betadex clathrate 16.Finerenone 17.Fluocortolone hydrat 18.Fluocortolone hexanoate 19.Fluocortolone pivalate 20.Gadobutrol 21.Gadoquatran 22.Gestodene 23.Hydroxyprogestrone caproate 24.Iopromide 25.Iotrolan 1) 26.Iotroxinic acid 27.Isoconazolnitrate 28.Levonorgestrel 29.Lidocaine hydrochloride 1) 30.Mesterolone 31.Metenolone acetate 32.Metenolone enantate 2) 33.Methylprednisolone aceponate 34.Molidustat Sodium 1) 35.Norethisterone 36.Norethisterone acetate 37.Norethisterone enantate enantate 38.Norgestrele 39.Prednisolone caproate 40.Rivaroxaban 41.Testosterone enantate 42.Testosterone undecanoate 2) 4 (text missing)

Withdrawal comments in English: GMP certificate has been superseded by document with the number DE_NW_01_GMP_2024_0017

Withdrawal comments in National Language: Das GMP-Zertifikat wurde ersetzt durch das Dokument mit der Nummer DE_NW_01_GMP_2024_0017

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.