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Spanish Agency Of Medicines And Medical Devices

CERTIFICATE NUMBER: ES/018HVI/25

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

Part 1

Issued following an inspection in accordance with
Art. 63 of Regulation (EU) 536/2014 as amended
Art. 111(5) of Directive 2001/83/EC as amended

The competent authority of Spain confirms the following:

The manufacturer: Universal Farma S.L.

Site address:

Calle El Tejido 2, Poligono Industrial Miralcampo, Azuqueca De Henares, 19200

OMS Organisation Id. / OMS Location Id.: ORG-100004655 / LOC-100038294

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. 6662 in accordance with Art. 61 of Regulation (EU) No 536/2014 and Art. 40 of Directive 2001/83/EC.

Other

(Human) artículo 63, Real Decreto Legislativo 1/2015, de 24 de julio, Real Decreto 824/2010, de 25 de junio, Reglamento Delegado (UE) 2017/1569, Directiva (UE) 2017/1572

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2024-06-27 , it is considered that it complies with:

The principles and guidelines of Good Manufacturing Practice laid down in Directive (EU) 2017/1572 and/or Commission Delegated Regulation (EU) 2017/1569, as reflected by the product categories stated in Part 2. (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. 15 of Directive 2001/20/EC and Art. 111(5) of Directive 2001/83/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

Human Medicinal Products
Human Investigational Medicinal Products

1 MANUFACTURING OPERATIONS

1.1 Sterile products

   1.1.1  Aseptically prepared (processing operations for the following dosage forms)
           1.1.1.2  Lyophilisates
           1.1.1.4  Small volume liquids
           1.1.1.6  Other: [HV] sustancias activas estériles/ esteril active substance(en)
   1.1.2  Terminally Sterilised (processing operations for the following dosage forms)
           1.1.2.3  Small volume liquids
   1.1.3  Batch certification

1.2 Non-sterile products

   1.2.1  Non-sterile products (processing operations for the following dosage forms)
           1.2.1.6  Liquids for internal use
   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
           1.3.1.5  Biotechnology products
   1.3.2  Batch Certification (list of product types)
           1.3.2.2  Immunological products

1.4 Other products or manufacturing activity

1.4.2 Sterilisation of active substance/ excipients/ finished product
1.4.2.1 Filtration

1.5 Packaging

   1.5.1  Primary Packaging
           1.5.1.6  Liquids for internal use
   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
   2.1.3  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

2.3 Other importation activities

2.3.1 Site of physical importation
2.3.2 Importation of intermediate which undergoes further processing

Clarifying remarks (for public users):

[F/HV]1.2.1.6, 1.5.1.6: inhalation solution.1.3.1.5: This authorization is restricted to the isolated phase of aseptic filling of the biotechnological products.1.1.2.3: Pre-filled syringes.1.6.4: bacterial endotoxin testingThis certificate is valid up to 27/06/2027.; [I/HV]2.1.4. Bacterial endotoxin assay2.3.2. Unlabeled prefilled srynges; [F/I]1.2.1.6, 1.5.1.6: inhalation solution.1.1.1.4: manufacture of cartridges is included.1.3.1.5: This authorization is restricted to the isolated phase of aseptic filling of the biotechnological products.1.1.2.3: Pre-filled syringes.1.6.4: bacterial endotoxin testingThis certificate is valid up to 27/06/2027.; [I/I]This certificate is valid up to 27/06/2027.;

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.