MIA Number: Authorisation Holder: Site Details DUNS Number: Name: City: Country:
[-- EEA -- ]
AFGHANISTAN
ALBANIA
ALGERIA
ANDORRA
ANGOLA
ANTIGUA AND BARBUDA
ARGENTINA
ARMENIA
AUSTRALIA
AUSTRIA
AZERBAIJAN
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BOSNIA AND HERZEGOVINA
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COSTA RICA
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CROATIA
CUBA
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DENMARK
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ECUADOR
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KOREA, REPUBLIC OF
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MEXICO
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MOLDOVA, REPUBLIC OF
MONACO
MONGOLIA
MONTENEGRO
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NEW ZEALAND
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OMAN
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PANAMA
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THAILAND
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VIETNAM
YEMEN
ZAMBIA
ZIMBABWE
Postcode: EudraGMDP Site Reference Number: NCA Reference Key: Legal Basis of Authorisation Art. 40 of Directive 2001/83/EC: Art. 44 of Directive 2001/82/EC: Art. 13 of Directive 2001/20/EC: Operations
Manufacturing Operations (Annex 1)
Manufacturing Operations (Annex 2)
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 [ 1.4.1.4 ]
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 packing [ 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 ]
Sterile investigational medicinal 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 investigational medicinal products [ 1.2 ]
Non-sterile investigational medicinal 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 ]
Other [ 1.2.1.15 ]
Biological investigational medicinal products [ 1.3 ]
Biological investigational medicinal products [ 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 investigational medicinal products or manufacturing activity [ 1.4 ]
Manufacture of [ 1.4.1 ]
Herbal products [ 1.4.1.1 ]
Homoeopathic products [ 1.4.1.2 ]
Other [ 1.4.1.4 ]
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 packing [ 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 (Annex 1)
Batch Operations (Annex 2)
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 ]
Sterile investigational medicinal products [ 1.1.3 ]
Non-sterile investigational medicinal products [ 1.2.2 ]
Biological investigational medicinal products [ 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 extracted products [ 1.3.2.6 ]
Tissue engineered products [ 1.3.2.7 ]
Other [ 1.3.2.8 ]
Primary packing Operations (Annex 1)
Primary packing Operations (Annex 2)
Packaging [ 1.5 ]
Primary Packing [ 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 ]
Packaging [ 1.5 ]
Primary Packing [ 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 ]
Other non-sterile medicinal products [ 1.5.1.15 ]
Importation Operations (Annex 1)
Importation Operations (Annex 2)
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 ]
Sterile investigational medicinal products [ 2.2.1 ]
Aseptically prepared [ 2.2.1.1 ]
Terminally sterilised [ 2.2.1.2 ]
Non-sterile investigational medicinal products [ 2.2.2 ]
Biological investigational 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 ]
