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The Certificate has been withdrawn, withdrawn date is : 2025-10-03

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Regierungspraesidium Tuebingen Leitstelle Arzneimittelueberwachung Baden-Wuerttemberg

CERTIFICATE NUMBER: DE_BW_01_GMP_2025_0030

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 Germany confirms the following:

The manufacturer: Biologische Heilmittel Heel GmbH

Site address:

Dr.-Reckeweg-Strasse 2-4, Oos, Baden-Baden, Baden-Wuerttemberg, 76532

OMS Organisation Id. / OMS Location Id.: ORG-100002226 / LOC-100002157

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. DE_BW_01_MIA_2023_0093 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 2024-10-24 , 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

   1.1.2  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)
           1.2.1.5  Liquids for external use
           1.2.1.6  Liquids for internal use
           1.2.1.11  Semi-solids
           1.2.1.12  Suppositories
           1.2.1.13  Tablets
           1.2.1.17  Other: Manufacture of Intermediates: mother tinctures, liquid dilutions (mixtures also) and triturations(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)
           1.3.1.6  Human or animal extracted products
   1.3.2  Batch Certification (list of product types)
           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
           1.4.1.2  Homoeopathic products
   1.4.2  Sterilisation of active substance/ excipients/ finished product
           1.4.2.3  Moist heat

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
           1.5.1.12  Suppositories
           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

2 IMPORTATION OF MEDICINAL PRODUCTS

2.3 Other importation activities

2.3.2 Importation of intermediate which undergoes further processing

Clarifying remarks (for public users):

The authorisation is based on floor plans included in document KON 000000887-06_EN, version 16. 1.1.2.3: Ampoules only. 1.2.1.13: Tablets does NOT include coated tablets. 1.3.1.6/1.3.2.6: homeopathic medicinal products only. 1.4.1.2: mother tinctures, liquid dilutions and triturations also. 2.3.2: mother tinctures, liquid dilutions and triturations only. Authorised manufacturing does NOT cover blood products, conventional immunological products (conventional sera, conventional vaccines, allergens, testsera and testantigenes) gene therapy medicinal products, somatic cell therapy medicinal products, tissue engineered products, xenogeneic products, tissue and cell products, medicinal products for use in in-vivo diagnosis by means of marker genes, biotechnology products and radiopharmaceuticals. The authorisation also covers storage and sampling at site Heinrich-Hertz-Str. 1A, 76470 Oetigheim.

Withdrawal comments in English: GMP certificate has been superseded by document with the number DE_BW_01_GMP_2025_0076

Withdrawal comments in National Language: Das GMP-Zertifikat wurde ersetzt durch das Dokument mit der Nummer DE_BW_01_GMP_2025_0076

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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.