Eudra GMP - Public Layout

MIA | GMP | API REG | WDA | GDP | Sites

Help

Tue 10 Nov 2026 15:31:28 BST

GMP Compliance Menu

GMP Certificates

Non-Compliance Report

The Certificate has been withdrawn, withdrawn date is : 2026-01-23

Print Preview

Print Preview (Short version)

Back To Search

Generalitat De Catalunya

CERTIFICATE NUMBER: NCF/2418/001/CAT

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

Part 1

Issued following an inspection in accordance with
Art. 111(5) of Directive 2001/83/EC as amended
Art. 94(1) of Regulation (EU) 2019/6 as amended
Art. 63 of Regulation (EU) 536/2014 as amended

The competent authority of Spain confirms the following:

The manufacturer: Laboratorio Reig Jofre S.A.

Site address:

Calle Gran Capita 10, Sant Joan Despi, 08970, Spain

OMS Organisation Id. / OMS Location Id.: ORG-100000940 / LOC-100001979

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. 0391 in accordance with Art. 88 of Regulation (EU) 2019/6, 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, Directiva 91/412/CE

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2023-11-22 , 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)

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. 111(5) of Directive 2001/83/EC, Art. 80(5) of Directive 2001/82/EC and Art. 15 of Directive 2001/20/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
Veterinary Medicinal Products

1 MANUFACTURING OPERATIONS

1.1 Sterile products

   1.1.1  Aseptically prepared (processing operations for the following dosage forms)
           1.1.1.2  Lyophilisates
                  Special Requirements:
                   7  Other: Other(en)
           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
   1.1.3  Batch certification

1.2 Non-sterile products

   1.2.1  Non-sterile products (processing operations for the following dosage forms)
           1.2.1.1  Capsules, hard shell
           1.2.1.5  Liquids for external use
                  Special Requirements:
                   7  Other: Other(en)
           1.2.1.6  Liquids for internal use
                  Special Requirements:
                   7  Other: Other(en)
           1.2.1.8  Other solid dosage forms
           1.2.1.13  Tablets
                  Special Requirements:
                   7  Other: Other(en)
   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
           1.3.1.6  Human or animal extracted products
   1.3.2  Batch Certification (list of product types)
           1.3.2.2  Immunological products
           1.3.2.5  Biotechnology products
           1.3.2.6  Human or animal extracted 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
           1.5.1.5  Liquids for external use
           1.5.1.6  Liquids for internal use
           1.5.1.8  Other solid dosage forms
           1.5.1.13  Tablets
   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

2.2 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
           2.2.3.5  Biotechnology products
           2.2.3.6  Human or animal extracted products

Clarifying remarks (for public users):

[F/HV]The manufacture of biological products does not include handling living organisms nor cellular cultures.1.3.1.2, 1.3.2.2 Immunological products: recombinant protein vaccines.The manufacture and storage of narcotic/psychotropic medicines is authorizedThis certificate is valid until 22/11/2025.; [F/I]The manufacture of biological products does not include handling living organisms nor cellular cultures.1.3.1.2, 1.3.2.2 Immunological products: recombinant protein vaccines.The manufacture and storage of narcotic/psychotropic medicines is authorizedThis certificate is valid until 22/11/2025.;

Withdrawal comments in English: The GMP compliance certificate has expired.

Withdrawal comments in National Language: El certificado de cumplimiento de NCF ha caducado.

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.