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Postcode:
OMS Organisation Identifier:
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EudraGMDP Site Reference Number:
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Additional Details on Units Inspected:
MIA Number:
Legal Basis Of Certificate
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Human / Art. 111(5) of Directive 2001/83/EC
Veterinary / Art. 80(5) of Directive 2001/82/EC
Veterinary / Art. 94(1) of Regulation (EU) 2019/6
Investigational Medicinal Product / Art. 63 of Regulation (EU) 536/2014
Investigational Medicinal Product / Art. 15 of Directive 2001/20/EC
GMP Non-Compliance Human / Art. 111(7) of Directive 2001/83/EC
GMP Non-Compliance Veterinary / Art. 80(7) of Directive 2001/82/EC
GMP Non-Compliance Veterinary / Art. 94(2) of Regulation (EU) 2019/6
Type of Inspection
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National Inspection Program
Art. 40 of Directive 2001/83/EC
Art. 44 of Directive 2001/82/EC
Art. 94(1) of Regulation (EU) 2019/6
Art. 13 of Directive 2001/20/EC
Art. 88 of Regulation (EU) 2019/6
Art. 61 of Regulation (EU) No 536/2014
Third Country Inspection Program
Art. 8(2) of Regulation (EC) 726/2004
Art. 33(2) of Regulation 726/2004/EC
Art. 19(3) of Regulation 726/2004/EC
Art. 44(3) of Regulation 726/2004/EC
Art. 111(4) of Directive 2001/83/EC
Art. 80(4) of Directive 2001/82/EC
Art. 94(4) of Regulation (EU) 2019/6
Excipient Manufacturer
Art. 111(1) of Directive 2001/83/EC
Active Substance Manufacturer
Art. 111(1) of Directive 2001/83/EC
Art. 80(1) of Directive 2001/82/EC
Art. 123(6) of Regulation (EU) 2019/6
Centralised Procedure for Manufacturers in the EEA
Art. 8(2) of Regulation (EC) 726/2004
Art. 33(2) of Regulation (EC) 726/2004
Inspections in Third Countries for IMP
Art. 15(4) of Directive 2001/20/EC
Art. 63 of Regulation (EU) 536/2014
Finished Product Program (Non Compliance)
Directive (EU) 2017/1572
Directive 91/412/EEC (Finished Products)
Directive (EU) 2017/1572
Active Substance Manufacturer (Non Compliance)
Article 47 of Directive 2001/83/EC (Active Substances)
Article 51 of Directive 2001/82/EC (Active Substances)
Article 93(2) of Regulation (EU) 2019/6
Commission Delegated Regulation (EU) 2017/1569
Other (Human)
Distant Assesment
Other (Human)
Operations
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MANUFACTURING OPERATIONS
Sterile products [ 1.1 ]
Aseptically prepared [ 1.1.1 ]
Large volume liquids [ 1.1.1.1 ]
Lyophilisates [ 1.1.1.2 ]
Semi-solids [ 1.1.1.3 ]
Small volume liquids [ 1.1.1.4 ]
Solids and implants [ 1.1.1.5 ]
Other [ 1.1.1.6 ]
Terminally sterilised [ 1.1.2 ]
Large volume liquids [ 1.1.2.1 ]
Semi-solids [ 1.1.2.2 ]
Small volume liquids [ 1.1.2.3 ]
Solids and implants [ 1.1.2.4 ]
Other [ 1.1.2.5 ]
Non-sterile products [ 1.2 ]
Non-sterile products [ 1.2.1 ]
Capsules, hard shell [ 1.2.1.1 ]
Capsules, soft shell [ 1.2.1.2 ]
Chewing gums [ 1.2.1.3 ]
Impregnated matrices [ 1.2.1.4 ]
Liquids for external use [ 1.2.1.5 ]
Liquids for internal use [ 1.2.1.6 ]
Medicinal gases [ 1.2.1.7 ]
Other solid dosage forms [ 1.2.1.8 ]
Pressurised preparations [ 1.2.1.9 ]
Radionuclide generators [ 1.2.1.10 ]
Semi-solids [ 1.2.1.11 ]
Suppositories [ 1.2.1.12 ]
Tablets [ 1.2.1.13 ]
Transdermal patches [ 1.2.1.14 ]
Intraruminal devices [ 1.2.1.15 ]
Veterinary premixes [ 1.2.1.16 ]
Other [ 1.2.1.17 ]
Biological medicinal products (list of product types) [ 1.3 ]
Biological medicinal products (list of product types) [ 1.3.1 ]
Blood products [ 1.3.1.1 ]
Immunological products [ 1.3.1.2 ]
Cell therapy products [ 1.3.1.3 ]
Gene therapy products [ 1.3.1.4 ]
Biotechnology products [ 1.3.1.5 ]
Human or animal extracted products [ 1.3.1.6 ]
Tissue engineered products [ 1.3.1.7 ]
Other products or manufacturing activity [ 1.4 ]
Manufacture of [ 1.4.1 ]
Herbal products [ 1.4.1.1 ]
Homoeopathic products [ 1.4.1.2 ]
Other [ 1.4.1.3 ]
Sterilisation of active substance/ excipients/ finished product [ 1.4.2 ]
Filtration [ 1.4.2.1 ]
Dry heat [ 1.4.2.2 ]
Moist heat [ 1.4.2.3 ]
Chemical [ 1.4.2.4 ]
Gamma irradiation [ 1.4.2.5 ]
Electron beam [ 1.4.2.6 ]
Other [ 1.4.3 ]
Packaging [ 1.5 ]
Secondary packaging [ 1.5.2 ]
Quality control testing [ 1.6 ]
Microbiological: sterility [ 1.6.1 ]
Microbiological: non-sterility [ 1.6.2 ]
Chemical/Physical [ 1.6.3 ]
Biological [ 1.6.4 ]
Other [ 1.3.1.8 ]
Batch Operations
Sterile products [ 1.1.3 ]
Non-sterile products [ 1.2.2 ]
Biological medicinal products (list of product types) [ 1.3.2 ]
Blood products [ 1.3.2.1 ]
Immunological products [ 1.3.2.2 ]
Cell therapy products [ 1.3.2.3 ]
Gene therapy products [ 1.3.2.4 ]
Biotechnology products [ 1.3.2.5 ]
Human or animal extracted products [ 1.3.2.6 ]
Tissue engineered products [ 1.3.2.7 ]
Other [ 1.3.2.8 ]
Primary packaging Operations
Packaging [ 1.5 ]
Primary Packaging [ 1.5.1 ]
Capsules, hard shell [ 1.5.1.1 ]
Capsules, soft shell [ 1.5.1.2 ]
Chewing gums [ 1.5.1.3 ]
Impregnated matrices [ 1.5.1.4 ]
Liquids for external use [ 1.5.1.5 ]
Liquids for internal use [ 1.5.1.6 ]
Medicinal gases [ 1.5.1.7 ]
Other solid dosage forms [ 1.5.1.8 ]
Pressurised preparations [ 1.5.1.9 ]
Radionuclide generators [ 1.5.1.10 ]
Semi-solids [ 1.5.1.11 ]
Suppositories [ 1.5.1.12 ]
Tablets [ 1.5.1.13 ]
Transdermal patches [ 1.5.1.14 ]
Intraruminal devices [ 1.5.1.15 ]
Veterinary premixes [ 1.5.1.16 ]
Other non-sterile medicinal products [ 1.5.1.17 ]
Importation Operations
Sterile products [ 2.2.1 ]
Aseptically prepared [ 2.2.1.1 ]
Terminally sterilised [ 2.2.1.2 ]
Non-sterile products [ 2.2.2 ]
Biological medicinal products [ 2.2.3 ]
Blood products [ 2.2.3.1 ]
Immunological products [ 2.2.3.2 ]
Cell therapy products [ 2.2.3.3 ]
Gene therapy products [ 2.2.3.4 ]
Biotechnology products [ 2.2.3.5 ]
Human or animal extracted products [ 2.2.3.6 ]
Tissue engineered products [ 2.2.3.7 ]
Quality control testing of imported medicinal products [ 2.1 ]
Microbiological: sterility [ 2.1.1 ]
Microbiological: non-sterility [ 2.1.2 ]
Chemical/Physical [ 2.1.3 ]
Biological [ 2.1.4 ]
Other [ 2.2.3.8 ]
Other importation activities [ 2.3 ]
Site of physical importation [ 2.3.1 ]
Importation of intermediate which undergoes further processing [ 2.3.2 ]
Biological active substance [ 2.3.3 ]
Other [ 2.3.4 ]
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