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The Spanish Agency Of Medicines And Medical Devices

CERTIFICATE NUMBER: ES/048HV/24

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 Spain confirms the following:

The manufacturer: Zoetis Manufacturing & Research Spain S.L.

Site address:

Carretera De Camprodon S/n Finca La Riba, La Vall De Bianya, 17813, Spain

OMS Organisation Id. / OMS Location Id.: ORG-100012170 / LOC-100019094

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. 0730 in accordance with Art. 88 of Regulation (EU) 2019/6.

Other

(Human) artículo 63, Real Decreto Legislativo 1/2015, de 24 de julio, Real Decreto 824/2010, de 25 de junio, Directiva 91/412/CE

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2024-04-05 , 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
           1.1.1.2  Lyophilisates
           1.1.1.4  Small volume liquids
                  Special Requirements:
                   7  Other: Other(en)
   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
           1.1.2.5  Other: [HV] Microesferas / Microespheres(en)
   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
           1.2.1.6  Liquids for internal use
           1.2.1.11  Semi-solids
   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
           1.3.1.8  Other: [HV] Sustancias activas biológicas / Biological active starting materials(en)
   1.3.2  Batch Certification (list of product types)
           1.3.2.2  Immunological products

1.5 Packaging

   1.5.1  Primary Packaging
           1.5.1.5  Liquids for external use
           1.5.1.6  Liquids for internal use
           1.5.1.11  Semi-solids
   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
           2.2.1.1  Aseptically prepared
           2.2.1.2  Terminally sterilised
   2.2.2  Non-sterile products
   2.2.3  Biological medicinal products
           2.2.3.2  Immunological products

2.3 Other importation activities

   2.3.1  Site of physical importation
   2.3.2  Importation of intermediate which undergoes further processing
   2.3.4  Other: [HV] Principios activos biológicos/Biological active substances(en)

Clarifying remarks (for public users):

[F/HV]1.1.1.4 Hormones or substances with hormonal activity.1.3.1.2 Immunological products: inactivated viral vaccine and viral live vaccine.1.3.1.8 Biological active starting materials: viral antigens.1.3.2.2 Batch certification of immunological products: inactivated viral vaccine and viral live vaccine.Manufacture and storage of medicinal products with narcotic/psychotropic special requirements are authorised.; [I/HV]Manufacture and storage of medicinal products with narcotic/psychotropic special requirements are authorised.;

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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.