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National Veterinary Medicines Agency

CERTIFICATE NUMBER: 26/404400

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: Nuvisan France S.A.R.L.

Site address:

2400 Route Des Colles, Biot, 06410, France

OMS Organisation Id. / OMS Location Id.: ORG-100032144 / LOC-100050284

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. V 271311/20 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 2024-07-19 , 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

1.1.3 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:
                   7  Other: (including notably those containing highly potent substances, hormones, cytostatics, cytotoxic substances)(en)
           1.2.1.6  Liquids for internal use
                  Special Requirements:
                   7  Other: (including notably those containing highly potent substances, hormones, cytostatics, cytotoxic substances)(en)
           1.2.1.11  Semi-solids
                  Special Requirements:
                   7  Other: (including notably those containing highly potent substances, hormones, cytostatics, cytotoxic substances)(en)
   1.2.2  Batch certification

1.3 Biological medicinal products (list of product types)

1.3.2 Batch Certification (list of product types)
1.3.2.5 Biotechnology products

1.4 Other products or manufacturing activity

1.4.1 Manufacture of
1.4.1.1 Herbal products

1.5 Packaging

   1.5.1  Primary Packaging
           1.5.1.1  Capsules, hard shell
                  Special Requirements:
                   7  Other: (including notably those containing highly potent substances, hormones, cytostatics, cytotoxic substances)(en)
           1.5.1.2  Capsules, soft shell
                  Special Requirements:
                   7  Other: (including notably those containing highly potent substances, hormones, cytostatics, cytotoxic substances)(en)
           1.5.1.5  Liquids for external use
                  Special Requirements:
                   7  Other: (including notably those containing highly potent substances, hormones, cytostatics, cytotoxic substances)(en)
           1.5.1.6  Liquids for internal use
                  Special Requirements:
                   7  Other: (including notably those containing highly potent substances, hormones, cytostatics, cytotoxic substances)(en)
           1.5.1.8  Other solid dosage forms: (including notably those containing highly potent substances, hormones, cytostatics, cytotoxic substances)(en)
           1.5.1.11  Semi-solids
                  Special Requirements:
                   7  Other: (including notably those containing highly potent substances, hormones, cytostatics, cytotoxic substances)(en)
           1.5.1.13  Tablets
                  Special Requirements:
                   7  Other: (including notably those containing highly potent substances, hormones, cytostatics, cytotoxic substances)(en)

1.6 Quality control testing

1.6.2 Microbiological: non-sterility
1.6.3 Chemical/Physical

2 IMPORTATION OF MEDICINAL PRODUCTS

2.1 Quality control testing of imported medicinal products

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
   2.2.3  Biological medicinal products
           2.2.3.5  Biotechnology products

2.3 Other importation activities

2.3.1 Site of physical importation

Clarifying remarks (for public users):

For veterinary medicinal product, this site is only authorised for batch certification and quality control. For veterinary investigational medicinal products, this site is authorised for the production of all the above-mentioned pharmaceutical forms, primary and secondary packaging, quality control, and batch certification. Non-sterile forms for veterinary investigational medicinal products include chemical product and herbal product. This site is also authorised to import veterinary investigational medicinal products for the same operations and pharmaceutical forms. This site is not authorised to manufacture radiopharmaceuticals or products containing penicillins, sulfonamides, cephalosporins, or ectoparasiticides. This site is authorised to manufacture products with highly potent substances, hormones,cytostatics, and cytotoxic substances.

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.