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The Certificate has been withdrawn, withdrawn date is : 2024-12-04

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Staatliches Gewerbeaufsichtsamt Oldenburg

CERTIFICATE NUMBER: DE_NI_04_GMP_2024_0014

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: Vet Pharma Friesoythe GmbH

Site address:

Sedelsberger Strasse 2-4, Friesoythe, Lower Saxony, 26169

OMS Organisation Id. / OMS Location Id.: ORG-100012278 / LOC-100019623

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. DE_NI_04_MIA_2024_0009 in accordance with Art. 88 of Regulation (EU) 2019/6.

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2024-11-07 , it is considered that it complies with:

The principles and guidelines of Good Manufacturing Practice laid down in Directive 91/412/EEC. (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. 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)
           1.1.1.1  Large volume liquids
                  Special Requirements:
                   2  Other highly sensitising materials
                   7  Other: higliy potent products highly toxic products narcotics(en)
           1.1.1.4  Small volume liquids
                  Special Requirements:
                   2  Other highly sensitising materials
                   7  Other: higliy potent products highly toxic products narcotics(en)
   1.1.2  Terminally Sterilised (processing operations for the following dosage forms)
           1.1.2.1  Large volume liquids
                  Special Requirements:
                   2  Other highly sensitising materials
                   7  Other: higliy potent products highly toxic products narcotics(en)
           1.1.2.3  Small volume liquids
                  Special Requirements:
                   2  Other highly sensitising materials
                   7  Other: higliy potent products highly toxic products narcotics(en)
           1.1.2.4  Solids and implants
                  Special Requirements:
                   6  Ectoparasiticides
   1.1.3  Batch certification

1.2 Non-sterile products

   1.2.1  Non-sterile products (processing operations for the following dosage forms)
           1.2.1.5  Liquids for external use
                  Special Requirements:
                   2  Other highly sensitising materials
           1.2.1.6  Liquids for internal use
                  Special Requirements:
                   2  Other highly sensitising materials
                   7  Other: highly potent products(en)
           1.2.1.11  Semi-solids
                  Special Requirements:
                   2  Other highly sensitising materials
   1.2.2  Batch certification

1.4 Other products or manufacturing activity

   1.4.2  Sterilisation of active substance/ excipients/ finished product
           1.4.2.1  Filtration
           1.4.2.3  Moist heat

1.5 Packaging

   1.5.1  Primary Packaging
           1.5.1.5  Liquids for external use
                  Special Requirements:
                   2  Other highly sensitising materials
           1.5.1.6  Liquids for internal use
                  Special Requirements:
                   2  Other highly sensitising materials
                   7  Other: highly potent products(en)
           1.5.1.11  Semi-solids
                  Special Requirements:
                   2  Other highly sensitising materials
   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

2.2.2 Non-sterile products

2.3 Other importation activities

2.3.1 Site of physical importation
2.3.4 Other: Active substances of microbial origin - Gentamicin sulphate(en)

Clarifying remarks (for public users):

The authoristaion covers manufacturing of medicinal products for animals only; To 1.1 - 1.5: The authorisation covers only manufacturing, not cover importation; To 1.2.1.11 and 1.5.1.11: Otic suspensions only To 1.1.2.4: Powder, terminally sterilised by gamma irradiation by external service provider; Acceptance inspection of the new production area on 07.05.2024; The authoristaion covers the warehouse locations: - VetPharma Friesoythe GmbH, Sedelsberger Str. 2, 26169 Friesoythe - VetPharma Friesoythe GmbH, c/o Hanenkamp Gruppe, Neuland 8, 26218 Boesel;

Withdrawal comments in English: GMP certificate has been superseded by document with the number DE_NI_04_GMP_2024_0017

Withdrawal comments in National Language: Das GMP-Zertifikat wurde ersetzt durch das Dokument mit der Nummer DE_NI_04_GMP_2024_0017

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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.