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Danish Medicines Agency

CERTIFICATE NUMBER: DK API-H 10001554

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

The competent authority of Denmark confirms the following:

The manufacturer: Alk-Abello A/S

Site address: Boege Alle 6/8, Hoersholm, Hovedstaden, 2970, Denmark

OMS Organisation Id. / OMS Location Id.: ORG-100001534 / LOC-100005491


Is an active substance manufacturer that has been inspected in accordance with Art. 111(1) of Directive 2001/83/EC0.

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on  2026-04-23 , it is considered that it complies with:

  • The principles of GMP for active substances referred to in Article 47 of Directive 2001/83/EC and an appropriate level of GMP as referred to in Article 46(f) of Directive 2001/83/EC.
    		•

    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/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

    Manufacture of active substance. Names of substances subject to inspection:
    BETULA VERRUCOSA (108)(en)
    PHLEUM PRATENSE (225)(en)
    AMBROSIA ARTEMISIIFOLIA (302)(en)
    DERMATOPHAGOIDES PTERONYSSINUS (503)(en)
    DERMATOPHAGOIDES FARINAE (504)(en)
    FELIS DOMESTICUS (555)(en)
    APIS MELLIFERA (801)(en)
    VESPULA SPP. (802)(en)
    CANIS FAMILIARIS (553)(en)

    3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

    Active Substance:BETULA VERRUCOSA (108)
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.1  Extraction of substance from plant source
    3.2.6  Purification of extracted substance Plant 
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Seperation by filtration,pressing,or centrifugation,vaccum packaging, dialysis, dia-ultrafiltration
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing
    3.6.2  Microbiological testing excluding sterility testing
    3.6.4  Biological Testing

    Active Substance:PHLEUM PRATENSE (225)
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.1  Extraction of substance from plant source
    3.2.6  Purification of extracted substance Plant 
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Seperation by filtration,pressing,or centrifugation,vaccum packaging, dialysis, dia-ultrafiltration
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing
    3.6.2  Microbiological testing excluding sterility testing
    3.6.4  Biological Testing

    Active Substance:AMBROSIA ARTEMISIIFOLIA (302)
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.1  Extraction of substance from plant source
    3.2.6  Purification of extracted substance Plant 
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Seperation by filtration,pressing,or centrifugation,vaccum packaging, dialysis, dia-ultrafiltration
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing
    3.6.2  Microbiological testing excluding sterility testing
    3.6.4  Biological Testing

    Active Substance:DERMATOPHAGOIDES PTERONYSSINUS (503)
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.2  Extraction of substance from animal source
    3.2.6  Purification of extracted substance Animal 
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Seperation by filtration,pressing,or centrifugation,vaccum packaging, dialysis, dia-ultrafiltration
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing
    3.6.2  Microbiological testing excluding sterility testing
    3.6.4  Biological Testing

    Active Substance:DERMATOPHAGOIDES FARINAE (504)
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.2  Extraction of substance from animal source
    3.2.6  Purification of extracted substance Animal 
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Seperation by filtration,pressing,or centrifugation,vaccum packaging, dialysis, dia-ultrafiltration
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing
    3.6.2  Microbiological testing excluding sterility testing
    3.6.4  Biological Testing

    Active Substance:FELIS DOMESTICUS (555)
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.2  Extraction of substance from animal source
    3.2.6  Purification of extracted substance Animal 
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Seperation by filtration,pressing,or centrifugation,vaccum packaging, dialysis, dia-ultrafiltration
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing
    3.6.2  Microbiological testing excluding sterility testing
    3.6.4  Biological Testing

    Active Substance:APIS MELLIFERA (801)
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.2  Extraction of substance from animal source
    3.2.6  Purification of extracted substance Animal 
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Seperation by filtration,pressing,or centrifugation,vaccum packaging, dialysis, dia-ultrafiltration
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing
    3.6.2  Microbiological testing excluding sterility testing
    3.6.4  Biological Testing

    Active Substance:VESPULA SPP. (802)
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.2  Extraction of substance from animal source
    3.2.6  Purification of extracted substance Animal 
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Seperation by filtration,pressing,or centrifugation,vaccum packaging, dialysis, dia-ultrafiltration
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing
    3.6.2  Microbiological testing excluding sterility testing
    3.6.4  Biological Testing

    Active Substance:CANIS FAMILIARIS (553)
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.2  Extraction of substance from animal source
    3.2.6  Purification of extracted substance Animal 
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Seperation by filtration,pressing,or centrifugation,vaccum packaging, dialysis, dia-ultrafiltration
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing
    3.6.2  Microbiological testing excluding sterility testing
    3.6.4  Biological Testing

     

     


    		 
    		 
     
         
     
     
    		 
     
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