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Operations

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Manufacturing Operations (Annex 1)	Manufacturing Operations (Annex 2)

Batch Operations (Annex 1)	Batch Operations (Annex 2)

Primary packaging Operations (Annex 1)	Primary packaging Operations (Annex 2)

Importation Operations (Annex 1)	Importation Operations (Annex 2)

The EudraGMDP database is maintained and operated by the EMA. Access to the general public is granted in order to enhance availability of information related to the EMA mandate. The content of the database is provided by the National Competent Authorities (NCA) of the EEA. For this reason, the EMA accepts no responsibility or liability whatsoever (including but not limited to any direct or consequential loss or damage it might occur to you and/or any other third party) arising out of or in connection with the information on this database. Any questions about the content should be addressed to the relevant NCA. Please click here to get list of NCA's.

Due to the restrictions caused by COVID-19, the period of validity of MIA’s, WDA’s, GMP and GDP certificates is automatically extended until the end of 2021. On-site inspections will resume as soon as there is a consensus that the period of the public health crisis has passed. The clarifying remark section of individual MIA’s, WDA’s, GMP and GDP certificates will indicate any exceptions. Competent authorities reserve the right to inspect a manufacturing site should the need arise.

For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI

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 ]

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 ]