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
BAHAMAS
BAHRAIN
BANGLADESH
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BELARUS
BELGIUM
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BENIN
BHUTAN
BOLIVIA, PLURINATIONAL STATE OF
BOSNIA AND HERZEGOVINA
BOTSWANA
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BULGARIA
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BURUNDI
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CAMEROON
CANADA
CAPE VERDE
CENTRAL AFRICAN REPUBLIC
CHAD
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CHINA
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COMOROS
CONGO
CONGO, THE DEMOCRATIC REPUBLIC OF THE
COSTA RICA
CÔTE D’IVOIRE
CROATIA
CUBA
CYPRUS
CZECHIA
DENMARK
DJIBOUTI
DOMINICA
DOMINICAN REPUBLIC
ECUADOR
EGYPT
EL SALVADOR
EQUATORIAL GUINEA
ERITREA
ESTONIA
ESWATINI
ETHIOPIA
FIJI
FINLAND
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GEORGIA
GERMANY
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IRAQ
IRELAND
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ITALY
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KENYA
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KOREA, REPUBLIC OF
KUWAIT
KYRGYZSTAN
LAO PEOPLE'S DEMOCRATIC REPUBLIC
LATVIA
LEBANON
LESOTHO
LIBERIA
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LIECHTENSTEIN
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MALDIVES
MALI
MALTA
MARSHALL ISLANDS
MAURITANIA
MAURITIUS
MEXICO
MICRONESIA, FEDERATED STATES OF
MOLDOVA, REPUBLIC OF
MONACO
MONGOLIA
MONTENEGRO
MOROCCO
MOZAMBIQUE
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NAMIBIA
NAURU
NEPAL
NETHERLANDS
NEW ZEALAND
NICARAGUA
NIGER
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NORTH MACEDONIA
NORWAY
OMAN
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PALESTINIAN TERRITORY, OCCUPIED
PANAMA
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PARAGUAY
PERU
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POLAND
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SAUDI ARABIA
SENEGAL
SERBIA
SEYCHELLES
SIERRA LEONE
SINGAPORE
SLOVAKIA
SLOVENIA
SOLOMON ISLANDS
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SOUTH AFRICA
SPAIN
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SUDAN
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SYRIA
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TAJIKISTAN
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THAILAND
TIMOR-LESTE
TOGO
TONGA
TRINIDAD AND TOBAGO
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TURKEY
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UGANDA
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UNITED KINGDOM
UNITED STATES
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UZBEKISTAN
VANUATU
VENEZUELA, BOLIVARIAN REPUBLIC OF
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 ]
