CERTIFICATE NUMBER:
DE_NW_02_GMP_2025_0016
CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER(1)
, (2)
Part 1
Issued following an inspection in accordance with
The competent authority of Germany confirms the following:
The manufacturer: Simtra Deutschland GmbH
Site address:
Kantstrasse 2, Kuensebeck, Halle (Westf), North Rhine-Westphalia, 33790, Germany
OMS Organisation Id. / OMS Location Id.: ORG-100004031 / LOC-100007567
Has been inspected under the national inspection programme in connection with manufacturing authorisation no.
DE_NW_02_MIA_2025_0013
in accordance with Art. 61 of Regulation (EU) No 536/2014 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).
From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on
2025-04-03
, 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.
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(1) The certificate referred to in paragraph Art. 111(5) of Directive 2001/83/EC and Art. 15 of Directive 2001/20/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)
1.1.2 Terminally Sterilised (processing operations for the following dosage forms)
1.1.3 Batch certification
1.2 Non-sterile products
1.2.2 Batch certification
1.3 Biological medicinal products (list of product types)
1.3.1 Biological medicinal products (list of product types)
1.3.2 Batch Certification (list of product types)
1.4 Other products or manufacturing activity
1.4.2 Sterilisation of active substance/ excipients/ finished product
1.5 Packaging
1.5.1 Primary 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
2.2.2 Non-sterile products
2.3 Other importation activities
2.3.1 Site of physical importation
2.3.2 Importation of intermediate which undergoes further processing
2.3.3 Biological active substance
2.3.4 Other: active pharmaceutical ingredients (API) / API-solutions: biotechnology products; hormon of human origin to be used as excipient; Albumin (human) U.S.P. 20% Grifols(en)
Clarifying remarks (for public users):
