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Ministry Of Social Affairs Health Women And Family

CERTIFICATE NUMBER: DE_SL_01_GMP_2025_0005

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

Part 1

Issued following an inspection in accordance with
Art. 94(1) of Regulation (EU) 2019/6 as amended

The competent authority of Germany confirms the following:

The manufacturer: Ursapharm Arzneimittel GmbH

Site address:

Industriestrasse 35, Buebingen, Saarbruecken, Saarland, 66129

OMS Organisation Id. / OMS Location Id.: ORG-100001735 / LOC-100000615

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. DE_SL_01_MIA_2024_0034 in accordance with Art. 88 of Regulation (EU) 2019/6.

Is an active substance manufacturer that has been inspected in accordance with Art. 123(6) of Regulation (EU) 2019/60.

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2024-10-31 , it is considered that it complies with:

The principles and guidelines of Good Manufacturing Practice laid down in Directive 91/412/EEC. (3)

The principles of GMP for active substances referred to in Art. 123(6) of Regulation (EU) 2019/6.

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. 80(5) of Directive 2001/82/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

Veterinary Medicinal Products

1 MANUFACTURING OPERATIONS

1.1 Sterile products

   1.1.1  Aseptically prepared (processing operations for the following dosage forms)
           1.1.1.3  Semi-solids
           1.1.1.4  Small volume liquids

1.4 Other products or manufacturing activity

   1.4.1  Manufacture of
           1.4.1.2  Homoeopathic products
   1.4.2  Sterilisation of active substance/ excipients/ finished product
           1.4.2.1  Filtration
           1.4.2.2  Dry heat

1.5 Packaging

   1.5.1  Primary Packaging
           1.5.1.5  Liquids for external use
           1.5.1.11  Semi-solids
   1.5.2  Secondary packaging

1.6 Quality control testing

1.6.1 Microbiological: sterility
1.6.3 Chemical/Physical

Clarifying remarks (for public users):

Veterinary Drugs: - to the dosage forms on eye drops (homeopathic)and eye ointments (chemical), sterile - for the production on the production steps up to the aseptic filling, primary processing pack, secundary processing pack - for product release with an indication that a final release for placing on the market is not taking place in your home

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.