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The Certificate has been withdrawn, withdrawn date is : 2025-01-16

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National Veterinary Medicines Agency

CERTIFICATE NUMBER: 24/365324

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 France confirms the following:

The manufacturer: Ceva Sante Animale

Site address:

10 Avenue De La Ballastiere, Libourne, 33500, France

OMS Organisation Id. / OMS Location Id.: ORG-100006786 / LOC-100010477

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. V 0728/84 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 2024-07-05 , 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
           1.1.1.4  Small volume liquids
   1.1.2  Terminally Sterilised (processing operations for the following dosage forms)
           1.1.2.1  Large volume liquids
           1.1.2.3  Small volume liquids
           1.1.2.4  Solids and implants
   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)
           1.3.1.2  Immunological products
   1.3.2  Batch Certification (list of product types)
           1.3.2.2  Immunological products

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

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

2.2 Batch certification of imported medicinal products

   2.2.1  Sterile products
           2.2.1.1  Aseptically prepared
           2.2.1.2  Terminally sterilised
   2.2.2  Non-sterile products

Clarifying remarks (for public users):

Manufacture of immunological products (1.3.1.2) concerns veterinary medicinal products TETANISERUM 150 ® and SRV RESPONS AI H5, for sterile form, aseptically prepared, 1.1.1.4 (Small volume liquids). For TETANISERUM 150 ®, the operations correspond to dilution, filling, secondary packaging, quality control and batch certification.For SRV RESPONS AI H5, the operations correspond to dilution, filling, secondary packaging and batch certification. This authorisation includes secondary packaging and storage for biological veterinary medicinal products.This site is authorised to manufacture products containing penicillin, sulphonamides, cephalosporins, and substances with hormonal activity. This site is not authorised to manufacture radiopharmaceuticals, cytotoxics, ectoparasiticides, and other potentially hazardous active ingredients. Storage and distribution of veterinary medicinal products are also realised in the annex located 164-166 AVENUE DE LA ROUDET, 33500 LIBOURNE

Withdrawal comments in English: Already registered certificate

Withdrawal comments in National Language: Certificat déjà enregistré

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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.