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The Certificate has been withdrawn, withdrawn date is : 2024-07-09

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Finnish Medicines Agency

CERTIFICATE NUMBER: FIMEA/2023/003960

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER

Part 1

The competent authority of Finland confirms the following:

The manufacturer: Bayer Oy

Site address:

Pansiontie 47, Turku, 20210, Finland

OMS Organisation Id. / OMS Location Id.: ORG-100000155 / LOC-100004966

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. FIMEA/2022/001428 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 2023-09-15 , it is considered that it complies with:

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

Part 2

Human Medicinal Products

1 MANUFACTURING OPERATIONS

1.1 Sterile products

   1.1.2  Terminally Sterilised (processing operations for the following dosage forms)
           1.1.2.4  Solids and implants
                  Special Requirements:
                   7  Other: substances with hormonal activity(en)
           1.1.2.5  Other: Intrauterine delivery system(en)
                  Special Requirements:
                   7  Other: substances with hormonal activity(en)
   1.1.3  Batch certification

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

Clarifying remarks (for public users):

Withdrawal comments in English: A new GMP certificate was issued due to MIA update

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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.