MIA Number: Authorisation Holder: Authorisation Holder OMS Organisation ID: Additional Details on Units Inspected: Site Details DUNS Number: - - Name: City: Country:
[-- EEA -- ]
AFGHANISTAN
ALBANIA
ALGERIA
ANDORRA
ANGOLA
ANTIGUA AND BARBUDA
ARGENTINA
ARMENIA
AUSTRALIA
AUSTRIA
AZERBAIJAN
BAHAMAS
BAHRAIN
BANGLADESH
BARBADOS
BELARUS
BELGIUM
BELIZE
BENIN
BHUTAN
BOLIVIA, PLURINATIONAL STATE OF
BOSNIA AND HERZEGOVINA
BOTSWANA
BRAZIL
BRUNEI DARUSSALAM
BULGARIA
BURKINA FASO
BURUNDI
CAMBODIA
CAMEROON
CANADA
CAPE VERDE
CENTRAL AFRICAN REPUBLIC
CHAD
CHILE
CHINA
COLOMBIA
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
FRANCE
GABON
GAMBIA
GEORGIA
GERMANY
GHANA
GREECE
GRENADA
GUATEMALA
GUINEA
GUINEA-BISSAU
GUYANA
HAITI
HOLY SEE (VATICAN CITY STATE)
HONDURAS
HUNGARY
ICELAND
INDIA
INDONESIA
IRAN, ISLAMIC REPUBLIC OF
IRAQ
IRELAND
ISRAEL
ITALY
JAMAICA
JAPAN
JORDAN
KAZAKHSTAN
KENYA
KIRIBATI
KOREA, DEMOCRATIC PEOPLE'S REPUBLIC OF
KOREA, REPUBLIC OF
KOSOVO
KUWAIT
KYRGYZSTAN
LAO PEOPLE'S DEMOCRATIC REPUBLIC
LATVIA
LEBANON
LESOTHO
LIBERIA
LIBYAN ARAB JAMAHIRIYA
LIECHTENSTEIN
LITHUANIA
LUXEMBOURG
MADAGASCAR
MALAWI
MALAYSIA
MALDIVES
MALI
MALTA
MARSHALL ISLANDS
MAURITANIA
MAURITIUS
MEXICO
MICRONESIA, FEDERATED STATES OF
MOLDOVA, REPUBLIC OF
MONACO
MONGOLIA
MONTENEGRO
MOROCCO
MOZAMBIQUE
MYANMAR
NAMIBIA
NAURU
NEPAL
NETHERLANDS
NEW ZEALAND
NICARAGUA
NIGER
NIGERIA
NORTH MACEDONIA
NORWAY
OMAN
PAKISTAN
PALESTINIAN TERRITORY, OCCUPIED
PANAMA
PAPUA NEW GUINEA
PARAGUAY
PERU
PHILIPPINES
POLAND
PORTUGAL
QATAR
ROMANIA
RUSSIAN FEDERATION
RWANDA
SAINT KITTS AND NEVIS
SAINT LUCIA
SAINT VINCENT AND THE GRENADINES
SAMOA
SAN MARINO
SÃO TOMÉ AND PRÍNCIPE
SAUDI ARABIA
SENEGAL
SERBIA
SEYCHELLES
SIERRA LEONE
SINGAPORE
SLOVAKIA
SLOVENIA
SOLOMON ISLANDS
SOMALIA
SOUTH AFRICA
SPAIN
SRI LANKA
SUDAN
SURINAME
SWEDEN
SWITZERLAND
SYRIA
TAIWAN
TAJIKISTAN
TANZANIA, UNITED REPUBLIC OF
THAILAND
TIMOR-LESTE
TOGO
TONGA
TRINIDAD AND TOBAGO
TUNISIA
TÜRKIYE
TURKMENISTAN
TUVALU
UGANDA
UKRAINE
UNITED ARAB EMIRATES
UNITED KINGDOM (NORTHERN IRELAND)
UNITED STATES
URUGUAY
UZBEKISTAN
VANUATU
VENEZUELA, BOLIVARIAN REPUBLIC OF
VIET NAM
YEMEN
ZAMBIA
ZIMBABWE
Postcode: OMS Location ID: EudraGMDP Site Reference Number: NCA Reference Key: Additional Details on Units Inspected: 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: Art. 88 of Regulation (EU) 2019/6: Art. 61 of Regulation (EU) No 536/2014: 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 [ 1.4.1.3 ]
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 ]
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 [ 1.4.1.3 ]
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 ]
Other [ 1.2.1.17 ]
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 packaging Operations (Annex 1)
Primary packaging Operations (Annex 2)
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 ]
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 ]
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 ]