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 ]