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File List
| File | Size |
|---|---|
| 0084/m1/eu/10-cover/ema/ema-cover.pdf | 219.66 KB |
| 0084/m1/eu/10-cover/ema/ema-tracking.pdf | 127.36 KB |
| 0084/m1/eu/12-form/ema/ema-form-annex.pdf | 150.91 KB |
| 0084/m1/eu/12-form/ema/ema-form-eaf-cert-pmf.pdf | 157.71 KB |
| 0084/m1/eu/responses/ema/ema-responses.pdf | 177.77 KB |
| 0084/m3/32-body-data/32s-drug-sub/plasma-human/32s2-manuf/control-of-materials-1-2-safe-strat.pdf | 299.66 KB |
| 0084/m3/32-body-data/32s-drug-sub/plasma-human/32s2-manuf/control-of-materials-1-3-gen-log.pdf | 72.44 KB |
| 0084/m3/32-body-data/32s-drug-sub/plasma-human/32s2-manuf/control-of-materials-2-1-1-info-centres.pdf | 308.73 KB |
| 0084/m3/32-body-data/32s-drug-sub/plasma-human/32s2-manuf/control-of-materials-2-1-4-trace.pdf | 67.8 KB |
| 0084/m3/32-body-data/32s-drug-sub/plasma-human/32s2-manuf/control-of-materials-2-2-2-testing.pdf | 147.42 KB |
| 0084/m3/32-body-data/32s-drug-sub/plasma-human/32s2-manuf/control-of-materials-2-2-3-char-plasma.pdf | 75.27 KB |
| 0084/m3/32-body-data/32s-drug-sub/plasma-human/32s2-manuf/control-of-materials-annex-2-info-collect.pdf | 248.09 KB |
| 0084/m3/32-body-data/32s-drug-sub/plasma-human/32s2-manuf/control-of-materials-annex-3-info-test.pdf | 110.7 KB |
| 0084/m3/32-body-data/32s-drug-sub/plasma-human/32s2-manuf/control-of-materials-annex-4-info-stor.pdf | 128.42 KB |
| 0084/m3/32-body-data/32s-drug-sub/plasma-human/32s2-manuf/control-of-materials-annex-5-info-trans.pdf | 154.35 KB |
| 0084/m3/32-body-data/32s-drug-sub/plasma-human/32s2-manuf/control-of-materials-annex-1-checklist-au.pdf | 194.98 KB |
| 0084/m3/32-body-data/32s-drug-sub/plasma-human/32s2-manuf/control-of-materials-app-5-2-screen-sero.pdf | 29.86 KB |
| 0084/m3/32-body-data/32s-drug-sub/plasma-human/32s2-manuf/control-of-materials-app-4-list-bags.pdf | 10.4 KB |
| 0084/m3/32-body-data/32s-drug-sub/plasma-human/32s2-manuf/control-of-materials-app-3b-test-sero.pdf | 14.31 KB |
| 0084/m3/32-body-data/32s-drug-sub/plasma-human/32s2-manuf/control-of-materials-app-3a-test-nat.pdf | 15.31 KB |
| 0084/m3/32-body-data/32s-drug-sub/plasma-human/32s2-manuf/control-of-materials-app-2b-epi-first.pdf | 25.19 KB |
| 0084/m3/32-body-data/32s-drug-sub/plasma-human/32s2-manuf/control-of-materials-app-2a-epi-rep.pdf | 244.67 KB |
| 0084/m3/32-body-data/32s-drug-sub/plasma-human/32s2-manuf/control-of-materials-app-2a-epi-first.pdf | 215.82 KB |
| 0084/m3/32-body-data/32s-drug-sub/plasma-human/32s2-manuf/control-of-materials-app-1-flow-supply.pdf | 13.65 KB |
| 0084/index-md5.txt | 32 B |
| 0084/index.xml | 9.46 KB |
| 0084/m1/eu/eu-regional.xml | 2.59 KB |
| 0084/util/dtd/eu-envelope.mod | 3.39 KB |
| 0084/util/dtd/eu-leaf.mod | 2.16 KB |
| 0084/util/dtd/eu-regional.dtd | 4.78 KB |
| 0084/util/dtd/ich-ectd-3-2.dtd | 30.66 KB |
| 0084/util/style/ectd-2-0.xsl | 2 KB |
| 0084/util/style/eu-regional.xsl | 25.04 KB |
| 0084-workingdocuments/control-of-materials-1-2-overall-safety-strategy_clean.docx | 82.62 KB |
| 0084-workingdocuments/control-of-materials-1-2-overall-safety-strategy_tracked.docx | 184.96 KB |
| 0084-workingdocuments/control-of-materials-1-3-general-logistics_clean.docx | 34.03 KB |
| 0084-workingdocuments/control-of-materials-1-3-general-logistics_tracked.docx | 36.55 KB |
| 0084-workingdocuments/control-of-materials-2-1-1-info-on-centres_clean.docx | 122.9 KB |
| 0084-workingdocuments/control-of-materials-2-1-1-info-on-centres_tracked.docx | 195.4 KB |
| 0084-workingdocuments/control-of-materials-2-1-4-traceability_clean.doc | 34.5 KB |
| 0084-workingdocuments/control-of-materials-2-1-4-traceability_tracked.doc | 35 KB |
| 0084-workingdocuments/control-of-materials-2-2-2-testing-plasma-donations-pools_clean.docx | 41.47 KB |
| 0084-workingdocuments/control-of-materials-2-2-2-testing-plasma-donations-pools_tracked.docx | 49.19 KB |
| 0084-workingdocuments/control-of-materials-2-2-3-characteristics-of-plasma-bags_clean.doc | 42 KB |
| 0084-workingdocuments/control-of-materials-2-2-3-characteristics-of-plasma-bags_tracked.doc | 44 KB |
| 0084-workingdocuments/control-of-materials-annex-1-checklist-on-annual-update 2025_clean.docx | 63.28 KB |
| 0084-workingdocuments/control-of-materials-annex-1-checklist-on-annual-update 2025_tracked.docx | 62.7 KB |
| 0084-workingdocuments/control-of-materials-annex-2-information-centres-establishments-blood-plasma_clean.docx | 101.56 KB |
| 0084-workingdocuments/control-of-materials-annex-2-information-centres-establishments-blood-plasma_tracked.docx | 255.82 KB |
| 0084-workingdocuments/control-of-materials-annex-3-info-centres-establishments-testing-donations-plasma-pools_clean.docx | 30.13 KB |
| 0084-workingdocuments/control-of-materials-annex-3-info-centres-establishments-testing-donations-plasma-pools_tracked.docx | 37.01 KB |
| 0084-workingdocuments/control-of-materials-annex-4-info-on-storage-establishments_clean.docx | 27.14 KB |
| 0084-workingdocuments/control-of-materials-annex-4-info-on-storage-establishments_tracked.docx | 40.99 KB |
| 0084-workingdocuments/control-of-materials-annex-5-information-organisations-transport-plasma_clean.docx | 24.69 KB |
| 0084-workingdocuments/control-of-materials-annex-5-information-organisations-transport-plasma_tracked.docx | 36.78 KB |
| 0084-workingdocuments/control-of-materials-appendix-1-flow-chart-of-supply-chain_clean.docx | 66.07 KB |
| 0084-workingdocuments/control-of-materials-appendix-1-flow-chart-of-supply-chain_tracked.docx | 81.65 KB |
| 0084-workingdocuments/control-of-materials-appendix-2a-epidemiological-data-first-time_KEDPLASMA.docx | 131.17 KB |
| 0084-workingdocuments/control-of-materials-appendix-2a-epidemiological-data-repeat_KEDPLASMA.docx | 142.65 KB |
| 0084-workingdocuments/control-of-materials-appendix-2b-epidemiological-data-first-time_B-Positive_clean.docx | 33.78 KB |
| 0084-workingdocuments/control-of-materials-appendix-2b-epidemiological-data-first-time_B-Positive_tracked.docx | 35.11 KB |
| 0084-workingdocuments/control-of-materials-appendix-3a-test-kits-nat_clean.docx | 25.41 KB |
| 0084-workingdocuments/control-of-materials-appendix-3a-test-kits-nat_tracked.docx | 26.27 KB |
| 0084-workingdocuments/control-of-materials-appendix-3b-test-kits-serological_clean.docx | 23.62 KB |
| 0084-workingdocuments/control-of-materials-appendix-3b-test-kits-serological_tracked.docx | 24.77 KB |
| 0084-workingdocuments/control-of-materials-appendix-4-list-plasma-bags-bottles_clean.doc | 36.5 KB |
| 0084-workingdocuments/control-of-materials-appendix-4-list-plasma-bags-bottles_tracked.doc | 38 KB |
| 0084-workingdocuments/control-of-materials-appendix-5.2-screening-serology_clean.docx | 28.89 KB |
| 0084-workingdocuments/control-of-materials-appendix-5.2-screening-serology_tracked.docx | 30.31 KB |
Trackers
No trackers found.