Decision
Key for MS and MANSA files
Updated 15 April 2024
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| Reference | Group Name | Section Name | Function |
|---|---|---|---|
| 1.1.1.1 | Sterile Products | Aseptically Prepared Dosage Form | Large volume liquids |
| 1.1.1.2 | Sterile Products | Aseptically Prepared Dosage Form | Lyophilisates |
| 1.1.1.3 | Sterile Products | Aseptically Prepared Dosage Form | Semi-solids |
| 1.1.1.4 | Sterile Products | Aseptically Prepared Dosage Form | Small volume liquids |
| 1.1.1.5 | Sterile Products | Aseptically Prepared Dosage Form | Solids and implants |
| 1.1.1.6 | Sterile Products | Aseptically Prepared Dosage Form | Other aseptically prepared products |
| 1.1.2.1 | Sterile Products | Terminally Sterilised Fosage Form | Large volume liquids |
| 1.1.2.2 | Sterile Products | Terminally Sterilised Fosage Form | Semi-solids |
| 1.1.2.3 | Sterile Products | Terminally Sterilised Fosage Form | Small volume liquids |
| 1.1.2.4 | Sterile Products | Terminally Sterilised Fosage Form | Solids and implants |
| 1.1.2.5 | Sterile Products | Terminally Sterilised Fosage Form | Other terminally sterilised prepared products |
| 1.2.1.1 | Non-sterile products | Non-Sterile Products Dosage Form | Capsules, hard shell |
| 1.2.1.2 | Non-sterile products | Non-Sterile Products Dosage Form | Capsules, soft shell |
| 1.2.1.3 | Non-sterile products | Non-Sterile Products Dosage Form | Chewing gums |
| 1.2.1.4 | Non-sterile products | Non-Sterile Products Dosage Form | Impregnated matrices |
| 1.2.1.5 | Non-sterile products | Non-Sterile Products Dosage Form | Liquids for external use |
| 1.2.1.6 | Non-sterile products | Non-Sterile Products Dosage Form | Liquids for internal use |
| 1.2.1.7 | Non-sterile products | Non-Sterile Products Dosage Form | Medicinal gases |
| 1.2.1.8 | Non-sterile products | Non-Sterile Products Dosage Form | Other solid dosage forms |
| 1.2.1.9 | Non-sterile products | Non-Sterile Products Dosage Form | Pressurised preparations |
| 1.2.1.10 | Non-sterile products | Non-Sterile Products Dosage Form | Radionuclide generators |
| 1.2.1.11 | Non-sterile products | Non-Sterile Products Dosage Form | Semi-solids |
| 1.2.1.12 | Non-sterile products | Non-Sterile Products Dosage Form | Suppositories |
| 1.2.1.13 | Non-sterile products | Non-Sterile Products Dosage Form | Tablets |
| 1.2.1.14 | Non-sterile products | Non-Sterile Products Dosage Form | Transdermal patches |
| 1.2.1.15 | Non-sterile products | Non-Sterile Products Dosage Form | Intraruminal devices |
| 1.2.1.16 | Non-sterile products | Non-Sterile Products Dosage Form | Veterinary premixes |
| 1.2.1.17 | Non-sterile products | Non-Sterile Products Dosage Form | Other non-sterile medicinal products |
| 1.3.1.1 | Biological/Actives | Biological medicinal products | Blood products |
| 1.3.1.2 | Biological/Actives | Biological medicinal products | Immunological products |
| 1.3.1.3 | Biological/Actives | Biological medicinal products | Cell therapy products |
| 1.3.1.4 | Biological/Actives | Biological medicinal products | Gene therapy products |
| 1.3.1.5 | Biological/Actives | Biological medicinal products | Biotechnology products |
| 1.3.1.6 | Biological/Actives | Biological medicinal products | Human or animal extracted products |
| 1.3.1.7 | Biological/Actives | Biological medicinal products | Other biological medicinal products |
| 1.4.1.1 | Other products or manufacturing activity | Manufacture of | Herbal products |
| 1.4.1.2 | Other products or manufacturing activity | Manufacture of | Homoeopathic products |
| 1.4.1.3 | Other products or manufacturing activity | Manufacture of | Biological active starting materials |
| 1.4.1.4 | Other products or manufacturing activity | Manufacture of | Other |
| 1.4.2.1 | Other products or manufacturing activity | Sterilisation of active substances/excipients/finished products | Filtration |
| 1.4.2.2 | Other products or manufacturing activity | Sterilisation of active substances/excipients/finished products | Dry heat |
| 1.4.2.3 | Other products or manufacturing activity | Sterilisation of active substances/excipients/finished products | Moist heat |
| 1.4.2.4 | Other products or manufacturing activity | Sterilisation of active substances/excipients/finished products | Chemical |
| 1.4.2.5 | Other products or manufacturing activity | Sterilisation of active substances/excipients/finished products | Gamma irradiation |
| 1.4.2.6 | Other products or manufacturing activity | Sterilisation of active substances/excipients/finished products | Electron beam |
| 1.4.3 | Other products or manufacturing activity | Others | Other |
| 1.5.1.1 | Packaging | Primary packing | Capsules, hard shell |
| 1.5.1.2 | Packaging | Primary packing | Capsules, soft shell |
| 1.5.1.3 | Packaging | Primary packing | Chewing gums |
| 1.5.1.4 | Packaging | Primary packing | Impregnated matrices |
| 1.5.1.5 | Packaging | Primary packing | Liquids for external use |
| 1.5.1.6 | Packaging | Primary packing | Liquids for internal use |
| 1.5.1.7 | Packaging | Primary packing | Medicinal gases |
| 1.5.1.8 | Packaging | Primary packing | Other solid dosage forms |
| 1.5.1.9 | Packaging | Primary packing | Pressurised preparations |
| 1.5.1.18 | Packaging | Primary packing | Radionuclide generators |
| 1.5.1.11 | Packaging | Primary packing | Semi-solids |
| 1.5.1.12 | Packaging | Primary packing | Suppositories |
| 1.5.1.13 | Packaging | Primary packing | Tablets |
| 1.5.1.14 | Packaging | Primary packing | Transdermal patches |
| 1.5.1.15 | Packaging | Primary packing | Intraruminal devices |
| 1.5.1.16 | Packaging | Primary packing | Veterinary premixes |
| 1.5.1.17 | Packaging | Primary packing | Other non-sterile medicinal products |
| 1.5.2 | Packaging | Secondary packing | Secondary packing |
| 1.6.1.1 | Process/Activities | Quality control testing | Microbiological: sterility |
| 1.6.1.2 | Process/Activities | Quality control testing | Microbiological: non-sterility |
| 1.6.1.3 | Process/Activities | Quality control testing | Chemical/Physical |
| 1.6.1.4 | Process/Activities | Quality control testing | Biological |
| 2.1 | Import | Not set | Not set |