Arvamus eelnõu kohta

Saatja: "Andrus Varki" <[email protected]> Saaja: "Info - SOM" <[email protected]> Teema: Eelnõu edastamine kooskõlastamiseks ja arvamuse avaldamiseks Kuupäev: 2026-01-28 16:10 Tähelepanu! Tegemist on välisvõrgust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. Teie: 06.01.2026 nr 1.2-2/2-1 Meie: 28.01.2026 nr JUR-3/128-2 Tere Ravimiametil on eelnõule kaks kommentaari: 1. Failis „SK_LISA2_rakendusaktide_kavandid_20251208.pdf“ lk 8 ja 9 punk § 9 lg 15 punkt 1 on sätestatud, et Ravimiamet edastab infosüsteemi: 1) teavet rakkude ja kudede hankimise, käitlemise ja siirdamise loa omajatest; Korrektne on: Ravimiamet edastab infosüsteemi: 1) teavet rakkude ja kudede hankimise ja käitlemise tegevusloa omajatest; 2. Vastavalt SoHO määruse 2024/1938 artiklile 31 tuleb liikmesriikidel SoHO platvormile esitama hakata käitlemisandmeid, mis suure tõenäosusega põhinevad varasemalt välja töötatud EDQM-i andmekoosseisudel. Failis „SK_LISA3_rakendusaktide_kavandid_20251208.pdf“ esitatud Viljatusravi ja suguraku doonorluse teatise andmekoosseis tundub EDQM-i andmekoosseisuga esialgsel hindamisel üldiselt sobivat, kuid vaja oleks lisada veel üks andmeväli, mis sobiks „Viljatusravi ja suguraku doonorluse teatise andmekoosseis“ punkti 13. alla. Näiteks nii: 13.13. inimeste arv, kellele munasarjakude siirdati. Põhjendus: See vastab EDQM-i andmekoosseisus esitatud andmeväljale FP a 9 # of patients who underwent an ovarian tissue transplantation, mis ei tundu hetkel andmekoosseisuga kaetud olevat. Lisan kirjale ka EDQM andmekoosseisu sisaldava faili. Viljatusravi puudutav osa on lk 12-14. Muus osas Ravimiametil tähelepanekuid ei ole. Lugupidamisega Andrus Varki Ravimiamet Õigusosakonna juhataja +372 737 4140 +372 737 4142 [email protected] <mailto:[email protected]> Nooruse 1 50411 Tartu www.ravimiamet.ee <http://www.ravimiamet.ee/> Selles e-kirjas sisalduv teave (kaasa arvatud manused) on mõeldud ametialaseks kasutamiseks ning seda võivad kasutada vaid e-kirja adressaadid. E-kirjas sisalduvat teavet ei tohi ilma saatja selgelt väljendatud loata edasi saata ega mis tahes viisil kolmandatele isikutele avaldada. Juhul, kui Te olete saanud käesoleva e-kirja eksituse tõttu, teavitage sellest koheselt saatjat ning kustutage e-kiri. This e-mail and any attachments transmitted may contain confidential and privileged information. If you are not the intended recipient, please notify the sender immediately by returning the e-mail and permanently deleting what you have received. Any dissemination or use of this information by a third person without permission is prohibited and may be illegal. ,ĂƌŵŽŶŝƐŝŶŐĂĐƚŝǀŝƚLJĚĂƚĂĐŽůůĞĐƚŝŽŶĞdžĞƌĐŝƐĞƐ ŝŶƚŚĞĨŝĞůĚŽĨƚŝƐƐƵĞƐĂŶĚĐĞůůƐŝŶƵƌŽƉĞ WͬW,ͬdK;ϮϭͿϬϮ tŽƌŬWĂĐŬĂŐĞϳͬ'ϮϬϭϴϱϯϬϭ d^d^&KZd/s/dzdZWKZd/E' ZĞƉůĂĐĞŵĞŶƚdŝƐƐƵĞƐ ,ĂĞŵĂƚŽƉŽŝĞƚŝĐWƌŽŐĞŶŝƚŽƌĞůůƐ DĞĚŝĐĂůůLJƐƐŝƐƚĞĚZĞƉƌŽĚƵĐƚŝŽŶ  REPLACEMENT TISSUES ACTIVITY DATA COUNTRY Year DONORS (COLLECTED AT NATIONAL LEVEL) NUMBERS UNITS/EXPLANATIONS DD Deceased donors # of deceased tissue/cell donors at national level LD Living donors # of living tissue/cell donors at national level OCULAR TISSUE NUMBERS UNITS/EXPLANATIONS OC 1 Living donors # of living ocular tissue/cell donors at national level Donors OC 2 Deceased donors # of deceased ocular tissue/cell donors at national level OC 3 Donations Ocular tissue donations # of donation events from one donor, may include 1 or 2 eyes/corneas OC 4 Cornea, full thickness (high endothelial cell density) # of corneas with endothelial cell density ≥ 2000 cells per mm2 OC 5 Cornea, full thickness (low endothelial cell density) # of corneas with endothelial cell density < 2000 cells per mm2 Releases for clinical application, OC 6 Cornea for Endothelial Keratoplasty (precut/peeled in the Tissue Establishment) # of corneas whether distributed or not OC 7 Sclera # of containers OC 8 Other ocular # of containers OC 9 Cornea, full thickness (high endothelial cell density) # of corneas with endothelial cell density ≥ 2000 cells per mm2 OC 10 Cornea, full thickness (low endothelial cell density) # of corneas with endothelial cell density < 2000 cells per mm2 Distributed to end user in the OC 11 Cornea for Endothelial Keratoplasty (precut/peeled in the Tissue Establishment) # of corneas country OC 12 Sclera # of containers OC 13 Other ocular # of containers OC 14 Cornea, full thickness (high endothelial cell density) # of corneas with endothelial cell density ≥ 2000 cells per mm2 OC 15 Cornea, full thickness (low endothelial cell density) # of corneas with endothelial cell density < 2000 cells per mm2 Distributed to end user in another OC 16 Cornea for Endothelial Keratoplasty (precut/peeled in the Tissue Establishment) # of corneas EU country OC 17 Sclera # of containers OC 18 Other ocular # of containers OC 19 Cornea, full thickness (high endothelial cell density) # of corneas with endothelial cell density ≥ 2000 cells per mm2 OCULAR OC 20 Cornea, full thickness (low endothelial cell density) # of corneas with endothelial cell density < 2000 cells per mm2 Sent to a tissue establishment OC 21 Cornea for Endothelial Keratoplasty (precut/peeled in the Tissue Establishment) # of corneas (transport) in another EU country OC 22 Sclera # of containers OC 23 Other ocular # of containers OC 24 Cornea, full thickness (high endothelial cell density) # of corneas with endothelial cell density ≥ 2000 cells per mm2 OC 25 Received from a tissue Cornea, full thickness (low endothelial cell density) # of corneas with endothelial cell density < 2000 cells per mm2 OC 26 establishment (transport) in Cornea for Endothelial Keratoplasty (precut/peeled in the Tissue Establishment) # of corneas OC 27 another EU country Sclera # of containers OC 28 Other ocular # of containers OC 29 Cornea, full thickness (high endothelial cell density) # of corneas with endothelial cell density ≥ 2000 cells per mm2 OC 30 Cornea, full thickness (low endothelial cell density) # of corneas with endothelial cell density < 2000 cells per mm2 Exports OC 31 Cornea for Endothelial Keratoplasty (precut/peeled in the Tissue Establishment) # of corneas (non EU) OC 32 Sclera # of containers OC 33 Other ocular # of containers OC 34 Cornea, full thickness (high endothelial cell density) # of corneas with endothelial cell density ≥ 2000 cells per mm2 OC 35 Cornea, full thickness (low endothelial cell density) # of corneas with endothelial cell density < 2000 cells per mm2 Imports OC 36 Cornea for Endothelial Keratoplasty (precut/peeled in the Tissue Establishment) # of corneas (non EU) OC 37 Sclera # of containers OC 38 Other ocular # of containers PA/PH/TO (21) 02 2 of 14 Work Package 7 / GA 2018 53 01  OC 39 Applications for Penetrating Keratoplasty # of applications (one surgical procedure, regardless of the # of grafts used) OC 40 Applications for Anterior Lamellar Keratoplasty # of applications (one surgical procedure, regardless of the # of grafts used) OC 41 Application procedures Applications for Endothelial Keratoplasty # of applications (one surgical procedure, regardless of the # of grafts used) OC 42 Applications for scleral reconstruction # of applications (one surgical procedure, regardless of the # of grafts used) OC 43 Applications for other ocular treatments (only use if the application does not fit into one of the above categories) # of applications (one surgical procedure, regardless of the # of grafts used) PLACENTAL TISSUE NUMBERS UNITS/EXPLANATIONS PL 1 Living donors # of living placental tissue donors at national level Donors PL 2 Deceased donors # of deceased placental tissue donors at national level PL 3 Donations Placental membrane donations # of donation events from one delivery, including multiple births PL 4 Amniotic membrane # of containers Releases for clinical application, PL 5 Amniotic membrane eyedrops # of batches prepared for a single patient whether distributed or not PL 6 Other placental # of containers PL 7 Amniotic membrane # of containers Distributed to end user in the PL 8 Amniotic membrane eyedrops # of batches prepared for a single patient country PL 9 Other placental # of containers PL 10 Amniotic membrane # of containers Distributed to end user in another PL 11 Amniotic membrane eyedrops # of batches prepared for a single patient EU country PLACENTAL PL 12 Other placental # of containers PL 13 Amniotic membrane # of containers Sent to a tissue establishment PL 14 Amniotic membrane eyedrops # of batches prepared for a single patient (transport) in another EU country PL 15 Other placental # of containers PL 16 Received from a tissue Amniotic membrane # of containers PL 17 establishment (transport) in Amniotic membrane eyedrops # of batches prepared for a single patient PL 18 another EU country Other placental # of containers PL 19 Amniotic membrane # of containers Exports PL 20 Amniotic membrane eyedrops # of batches prepared for a single patient (non EU) PL 21 Other placental # of containers PL 22 Amniotic membrane # of containers Imports PL 23 Amniotic membrane eyedrops # of batches prepared for a single patient (non EU) PL 24 Other placental # of containers PL 25 Amniotic membrane applications for ocular treatment (excluding amniotic eye drops) # of applications (one surgical procedure, regardless of the # of grafts used) PL 26 Amniotic membrane applications for ocular treatment (amniotic eye drops) # of batches prepared for a single patient PL 27 Application procedures Amniotic membrane applications for non-ocular burn/wound healing # of applications (one surgical procedure, regardless of the # of grafts used) PL 28 Amniotic membrane applications for other treatments # of applications (one surgical procedure, regardless of the # of grafts used) PL 29 Other placental tissue applications (only use if the application does not fit into one of the above categories) # of applications (one surgical procedure, regardless of the # of grafts used) CUTANEOUS TISSUE NUMBERS UNITS/EXPLANATIONS CU 1 Living donors # of living cutaneous tissue donors at national level Donors CU 2 Deceased donors # of deceased cutaneous tissue donors at national level CU 3 Donations Skin donations # of donation events from one donor, regardless of the number of tissues obtained CU 4 Skin cm2 CU 5 Releases for clinical application, Acellular dermal matrix cm2 CU 6 whether distributed or not Keratinocytes/melanocytes # of containers CU 7 Other cutaneous tissues # of containers CU 8 Skin cm2 CU 9 Distributed to end user in the Acellular dermal matrix cm2 CU 10 country Keratinocytes/melanocytes # of containers CU 11 Other cutaneous tissues # of containers Work Package 7 / GA 2018 53 01 3 of 14 PA/PH/TO (21) 02  CU 12 Skin cm2 CU 13 Distributed to end user in another Acellular dermal matrix cm2 CU 14 EU country Keratinocytes/melanocytes # of containers CUTANEOUS CU 15 Other cutaneous tissues # of containers CU 16 Skin cm2 CU 17 Sent to a tissue establishment Acellular dermal matrix cm2 CU 18 (transport) in another EU country Keratinocytes/melanocytes # of containers CU 19 Other cutaneous tissues # of containers CU 20 Skin cm2 CU 21 Received from a tissue Acellular dermal matrix cm2 establishment (transport) in CU 22 another EU country Keratinocytes/melanocytes # of containers CU 23 Other cutaneous tissues # of containers CU 24 Skin cm2 CU 25 Exports Acellular dermal matrix cm2 CU 26 (non EU) Keratinocytes/melanocytes # of containers CU 27 Other cutaneous tissues # of containers CU 28 Skin cm2 CU 29 Imports Acellular dermal matrix cm2 CU 30 (non EU) Keratinocytes/melanocytes # of containers CU 31 Other cutaneous tissues # of containers CU 32 Applications for burns/wound healing # of applications (one surgical procedure, regardless of the # of grafts used) CU 33 Application procedures Applications for reconstructive surgery # of applications (one surgical procedure, regardless of the # of grafts used) CU 34 Applications for other treatments (only use if the application does not fit into one of the above categories) # of applications (one surgical procedure, regardless of the # of grafts used) CARDIAC TISSUE NUMBERS UNITS/EXPLANATIONS CA 1 Living donors # of living cardiac tissue donors at national level Donors CA 2 Deceased donors # of deceased cardiac tissue donors at national level CA 3 Donations Cardiac tissue donations # of donation events from one donor, regardless of the number of tissues obtained CA 4 HV, aortic # of HV CA 5 HV, pulmonary # of HV CA 6 HV, aortic decellularised # of HV Releases for clinical application, CA 7 HV, pulmonary decellularised # of HV whether distributed or not CA 8 Non-valved patches and conduits # of containers CA 9 Pericardium # of containers CA 10 Other heart tissues # of containers CA 11 HV, aortic # of HV CA 12 HV, pulmonary # of HV CA 13 HV, aortic decellularised # of HV Distributed to end user in the CA 14 HV, pulmonary decellularised # of HV country CA 15 Non-valved patches and conduits # of containers CA 16 Pericardium # of containers CA 17 Other heart tissues # of containers CA 18 HV, aortic # of HV CA 19 HV, pulmonary # of HV CA 20 HV, aortic decellularised # of HV Distributed to end user in another CA 21 HV, pulmonary decellularised # of HV EU country CA 22 Non-valved patches and conduits # of containers CA 23 Pericardium # of containers CA 24 Other heart tissues # of containers PA/PH/TO (21) 02 4 of 14 Work Package 7 / GA 2018 53 01 CARDIAC CA 25 HV, aortic # of HV CA 26 HV, pulmonary # of HV CA 27 HV, aortic decellularised # of HV Sent to a tissue establishment CA 28 HV, pulmonary decellularised # of HV (transport) in another EU country CA 29 Non-valved patches and conduits # of containers CA 30 Pericardium # of containers CA 31 Other heart tissues # of containers CA 32 HV, aortic # of HV CA 33 HV, pulmonary # of HV CA 34 Received from a tissue HV, aortic decellularised # of HV CA 35 establishment (transport) in HV, pulmonary decellularised # of HV CA 36 another EU country Non-valved patches and conduits # of containers CA 37 Pericardium # of containers CA 38 Other heart tissues # of containers CA 39 HV, aortic # of HV CA 40 HV, pulmonary # of HV CA 41 HV, aortic decellularised # of HV Exports CA 42 HV, pulmonary decellularised # of HV (non EU) CA 43 Non-valved patches and conduits # of containers CA 44 Pericardium # of containers CA 45 Other heart tissues # of containers CA 46 HV, aortic # HV CA 47 HV, pulmonary # HV CA 48 HV, aortic decellularised # HV Imports CA 49 HV, pulmonary decellularised # HV (non EU) CA 50 Non-valved patches and conduits # of containers CA 51 Pericardium # of containers CA 52 Other heart tissues # of containers CA 53 Applications for HV replacement # of applications (one surgical procedure, regardless of the # of grafts used) CA 54 Application procedures Applications for cardiac reconstruction # of applications (one surgical procedure, regardless of the # of grafts used) CA 55 Applications for other treatments (only use if the application does not fit into one of the above categories) # of applications (one surgical procedure, regardless of the # of grafts used) VESSELS NUMBERS UNITS/EXPLANATIONS VE 1 Living donors # of living vessel donors at national level Donors VE 2 Deceased donors # of deceased vessel donors at national level VE 3 Donations Vessel donations # of donation events from one donor, regardless of the number of tissues obtained VE 4 Releases for clinical application, Vessels, arteries # of containers VE 5 whether distributed or not Vessels, veins # of containers VE 6 Distributed to end user in the Vessels, arteries # of containers VE 7 country Vessels, veins # of containers VESSELS VE 8 Distributed to end user in another Vessels, arteries # of containers VE 9 EU country Vessels, veins # of containers VE 10 Sent to a tissue establishment Vessels, arteries # of containers VE 11 (transport) in another EU country Vessels, veins # of containers VE 12 Received from a tissue Vessels, arteries # of containers establishment (transport) in VE 13 another EU country Vessels, veins # of containers VE 14 Exports Vessels, arteries # of containers VE 15 (non EU) Vessels, veins # of containers Work Package 7 / GA 2018 53 01 5 of 14 PA/PH/TO (21) 02  VE 16 Imports Vessels, arteries # of containers VE 17 (non EU) Vessels, veins # of containers VE 18 Application procedures Applications # of applications (one surgical procedure, regardless of the # of grafts used) MUSCULOSKELETAL TISSUE NUMBERS UNITS/EXPLANATIONS # of living musculoskeletal tissue donors at national level MU 1 Living donors (including for autologous use of cranial bone and cartilage) Donors MU 2 Deceased donors # of deceased musculoskeletal tissue donors at national level # of donation events from one donor, regardless of the number of MU 3 Donations Musculoskeletal tissue donations tissues obtained (including for autologous use of cranial bone and cartilage) MU 4 Whole or part of structural/supporting bone # of pieces MU 5 Tendons (including with bony attachments)/ligaments/fascia # of pieces MU 6 Osteochondral grafts # of pieces MU 7 Releases for clinical application, Bone filling material (excluding femoral heads) # of containers MU 8 whether distributed or not Femoral heads # of containers MU 9 Demineralised bone matrix (including combined with a carrier) # of containers MU 10 Meniscus # of pieces MU 11 Other musculoskeletal (e.g. ear ossicles, cranial bone, cartilage) # of containers MU 12 Whole or part of structural/supporting bone # of pieces MU 13 Tendons (including with bony attachments)/ligaments/fascia # of pieces MU 14 Osteochondral grafts # of pieces MU 15 Distributed to end user in the Bone filling material (excluding femoral heads) # of containers MU 16 country Femoral heads # of containers MU 17 Demineralised bone matrix (including combined with a carrier) # of containers MU 18 Meniscus # of pieces MU 19 Other musculoskeletal (e.g. ear ossicles, cranial bone, cartilage) # of containers MU 20 Whole or part of structural/supporting bone # of pieces MU 21 Tendons (including with bony attachments)/ligaments/fascia # of pieces MU 22 Osteochondral grafts # of pieces MU 23 Distributed to end user in another Bone filling material (excluding femoral heads) # of containers MU 24 EU country Femoral heads # of containers MU 25 Demineralised bone matrix (including combined with a carrier) # of containers MU 26 Meniscus # of pieces MUSKULOSKELETAL MU 27 Other musculoskeletal (e.g. ear ossicles, cranial bone, cartilage) # of containers MU 28 Whole or part of structural/supporting bone # of pieces MU 29 Tendons (including with bony attachments)/ligaments/fascia # of pieces MU 30 Osteochondral grafts # of pieces MU 31 Sent to a tissue establishment Bone filling material (excluding femoral heads) # of containers MU 32 (transport) in another EU country Femoral heads # of containers MU 33 Demineralised bone matrix (including combined with a carrier) # of containers MU 34 Meniscus # of pieces MU 35 Other musculoskeletal (e.g. ear ossicles, cranial bone, cartilage) # of containers MU 36 Whole or part of structural/supporting bone # of pieces MU 37 Tendons (including with bony attachments)/ligaments/fascia # of pieces MU 38 Osteochondral grafts # of pieces MU 39 Received from a tissue Bone filling material (excluding femoral heads) # of containers establishment (transport) in MU 40 another EU country Femoral heads # of containers MU 41 Demineralised bone matrix (including combined with a carrier) # of containers MU 42 Meniscus # of pieces MU 43 Other musculoskeletal (e.g. ear ossicles, cranial bone, cartilage) # of containers PA/PH/TO (21) 02 6 of 14 Work Package 7 / GA 2018 53 01  MU 44 Whole or part of structural/supporting bone # of pieces MU 45 Tendons (including with bony attachments)/ligaments/fascia # of pieces MU 46 Osteochondral grafts # of pieces MU 47 Exports Bone filling material (excluding femoral heads) # of containers MU 48 (non EU) Femoral heads # of containers MU 49 Demineralised bone matrix (including combined with a carrier) # of containers MU 50 Meniscus # of pieces MU 51 Other musculoskeletal (e.g. ear ossicles, cranial bone, cartilage) # of containers MU 52 Whole or part of structural/supporting bone # of pieces MU 53 Tendons (including with bony attachments)/ligaments/fascia # of pieces MU 54 Osteochondral grafts # of pieces MU 55 Imports Bone filling material (excluding femoral heads) # of containers MU 56 (non EU) Femoral heads # of containers MU 57 Demineralised bone matrix (including combined with a carrier) # of containers MU 58 Meniscus # of pieces MU 59 Other musculoskeletal (e.g. ear ossicles, cranial bone, cartilage) # of containers MU 60 Application for orthopaedic/maxillofacial surgery # of applications (one surgical procedure, regardless of the # of grafts used) MU 61 Application procedures Application for dental procedures # of applications (one surgical procedure, regardless of the # of grafts used) MU 62 Applications for other treatments (only use if the application does not fit into one of the above categories) # of applications (one surgical procedure, regardless of the # of grafts used) NEURONAL TISSUE NUMBERS UNITS/EXPLANATIONS NE 1 Living donors # of living neuronal tissue donors at national level Donors NE 2 Deceased donors # of deceased neuronal tissue donors at national level # of donation events from one donor, regardless of the NE 3 Donations Nerve donations number of tissues obtained Releases for clinical application, NE 4 Nerves # of containers whether distributed or not Distributed to end user in the NE 5 Nerves # of containers country NEURONAL Distributed to end user in another NE 6 Nerves # of containers EU country Sent to a tissue establishment NE 7 Nerves # of containers (transport) in another EU country Received from a tissue NE 8 establishment (transport) in Nerves # of containers another EU country Exports NE 9 Nerves # of containers (non EU) Imports NE 10 Nerves # of containers (non EU) NE 11 Application procedures Applications # of applications (one surgical procedure, regardless of the # of grafts used) ADIPOSE TISSUE NUMBERS UNITS/EXPLANATIONS AD 1 Living donors # of living adipose tissue donors at national level Donors AD 2 Deceased donors # of deceased adipose tissue donors at national level AD 3 Donations Adipose tissue donations # of donation events from one donor, regardless of the number of tissues obtained Work Package 7 / GA 2018 53 01 7 of 14 PA/PH/TO (21) 02  Releases for clinical application, AD 4 Adipose tissue # of containers whether distributed or not Distributed to end user in the AD 5 Adipose tissue # of containers country Distributed to end user in another AD 6 Adipose tissue # of containers ADIPOSE EU country Sent to a tissue establishment AD 7 Adipose tissue # of containers (transport) in another EU country Received from a tissue AD 8 establishment (transport) in Adipose tissue # of containers another EU country Exports AD 9 Adipose tissue # of containers (non EU) Imports AD 10 Adipose tissue # of containers (non EU) AD 11 Applications for reconstructive surgery # of applications (one surgical procedure, regardless of the # of grafts used) AD 12 Application procedures Applications for aesthetic surgery # of applications (one surgical procedure, regardless of the # of grafts used) AD 13 Applications for other treatments (only use if the application does not fit into one of the above categories) # of applications (one surgical procedure, regardless of the # of grafts used) PANCREATIC TISSUE NUMBERS UNITS/EXPLANATIONS PA 1 Living donors # of living pancreatic tissue donors at national level Donors PA 2 Deceased donors # of deceased pancreatic tissue donors at national level PA 3 Donations Pancreatic tissue donations # of donation events from one donor, regardless of the number of tissues obtained Releases for clinical application, PA 4 Pancreatic islets # of containers whether distributed or not Distributed to end user in the PA 5 Pancreatic islets # of containers country PANCREATIC Distributed to end user in another PA 6 Pancreatic islets # of containers EU country Sent to a tissue establishment PA 7 Pancreatic islets # of containers (transport) in another EU country Received from a tissue PA 8 establishment (transport) in Pancreatic islets # of containers another EU country Exports PA 9 Pancreatic islets # of containers (non EU) Imports PA 10 Pancreatic islets # of containers (non EU) PA 11 Application procedures Applications # of applications (one single procedure, regardless of the # of grafts used) HEPATIC TISSUE NUMBERS UNITS/EXPLANATIONS HE 1 Living donors # of living hepatic tissue donors at national level Donors HE 2 Deceased donors # of deceased hepatic tissue donors at national level HE 3 Donations Hepatic tissue donations # of donation events from one donor, regardless of the number of tissues obtained PA/PH/TO (21) 02 8 of 14 Work Package 7 / GA 2018 53 01  Releases for clinical application, HE 4 Hepatocytes # of containers whether distributed or not Distributed to end user in the HE 5 Hepatocytes # of containers country HEPATIC Distributed to end user in another HE 6 Hepatocytes # of containers EU country Sent to a tissue establishment HE 7 Hepatocytes # of containers (transport) in another EU country Received from a tissue HE 8 establishment (transport) in Hepatocytes # of containers another EU country Exports HE 9 Hepatocytes # of containers (non EU) Imports HE 10 Hepatocytes # of containers (non EU) HE 11 Application procedures Applications # of applications (one procedure, regardless of the # of grafts used) PARATHYROID TISSUE NUMBERS UNITS/EXPLANATIONS PR 1 Living donors # of living parathyroid tissue donors at national level Donors PR 2 Deceased donors # of deceased parathyroid tissue donors at national level PR 3 Donations Parathyroid tissue donations # of donation events from one donor, regardless of the number of tissues obtained Releases for clinical application, PR 4 Parathyroid tissue # of containers whether distributed or not Distributed to end user in the PR 5 Parathyroid tissue # of containers PARATHYROID country Distributed to end user in another PR 6 Parathyroid tissue # of containers EU country Sent to a tissue establishment PR 7 Parathyroid tissue # of containers (transport) in another EU country Received from a tissue PR 8 establishment (transport) in Parathyroid tissue # of containers another EU country Exports PR 9 Parathyroid tissue # of containers (non EU) Imports PR 10 Parathyroid tissue # of containers (non EU) PR 11 Application procedures Applications # of applications (one surgical procedure, regardless of the # of grafts used) Work Package 7 / GA 2018 53 01 9 of 14 PA/PH/TO (21) 02  HAEMATOPOIETIC CELLS ACTIVITY DATA COUNTRY YEAR Registered at POTENTIAL FOR ALLOGENEIC DONATION 01/01 00:00 SS a 1 # of registered and typed HPC donors SELF-SUFFICIENCY SS a 2 # of registered and typed cord blood units available for transplantation of unrelated patients DISTRIBUTION AND EXCHANGE DISTRIBUTED IMPORT EXPORT From EU From non-EU To non-EU # of unrelated (unit: Cell product from one donor, regardless of the number of donations/containers) Nationally To EU countries countries countries countries SS b 1 HPC from bone marrow for transplantation SS b 2 HPC from peripheral blood for transplantation SS b 3 Peripheral blood mononuclear cells for transplant support (e.g. donor lymphocytes for infusion) SS b 4 Peripheral blood mononuclear cells for other purposes, excluding ATMP (e.g. production of CAR-T cells, NK cells) SS b 5 HPC from cord blood for transplantation ALLOGENEIC DONATION/COLLECTION DONATION CENTRE Related donor AUTOLOGOUS Unrelated # of donations (unit: Cell product collected from one donor in one donation procedure - may encompass more than Paediatric registry donor Adult one apheresis session) (<18 yr.) DC a 1 HPC from bone marrow for transplantation DC a 2 HPC from peripheral blood for transplantation DC a 3 Peripheral blood mononuclear cells for transplant support (e.g. donor lymphocytes for infusion) DC a 4 Peripheral blood mononuclear cells for other purposes, excluding ATMP (e.g. production of CAR-T cells, NK cells) DC a 5 HPC from cord blood DC a 6 Other cells (e.g. bone marrow for other purposes), excluding ATMP TISSUE ESTABLISHEMENT RELEASED FOR CLINICAL APPLICATION AUTOLOGOUS ALLOGENEIC # released for clinical application, whether distributed or not (unit: Cell product collected from one donor in one Unrelated Related donor donation procedure - may encompass more than one apheresis session) registry donor TE a 1 HPC from bone marrow for transplantation TE a 2 HPC from peripheral blood for transplantation TE a 3 Peripheral blood mononuclear cells for transplant support (e.g. donor lymphocytes for infusion) TE a 4 Peripheral blood mononuclear cells for other purposes, excluding ATMP (e.g. production of CAR-T cells, NK cells) TE a 5 HPC from cord blood for transplantation TE a 6 Cord blood for other purposes, excluding ATMP (e.g. production of NK cells, mesenchymals) TE a 7 Other cells (e.g. bone marrow for other purposes), excluding ATMP PA/PH/TO (21) 02 10 of 14 Work Package 7 / GA 2018 53 01  AUTOLOGOUS ALLOGENEIC TRANSPLANT PROCEDURES ASSOCIATED WITH CLINICAL APPLICATION Unrelated Related donor registry donor TC a 1 # of transplants (unit: One transplant procedure with cells obtained from one or more donors) TRANSPLANT CENTRES TC a 2 # of recipients (unit: One patient who had at least one transplant procedure during the year concerned) TC a 3 HPC from bone marrow for transplantation TC a 4 HPC from peripheral blood for transplantation TC a 5 HPC from cord blood for transplantation AUTOLOGOUS ALLOGENEIC OTHER PROCEDURES ASSOCIATED WITH CLINICAL APPLICATION Unrelated Related donor registry donor TC b 1 # of procedures (unit: One application with cells obtained from one or more donors) TC b 2 # of recipients (unit: One patient who had at least one procedure during the year concerned) TC b 3 Peripheral blood mononuclear cells for transplant support (e.g. donor lymphocytes for infusion) TC b 4 Peripheral blood mononuclear cells for other purposes (e.g. NK cells, Tregs, virus-specific cells), excluding ATMP TC b 5 Other cells for other purposes, excluding ATMP 11 of 14 PA/PH/TO (21) 02 Work Package 7 / GA 2018 53 01  MAR ACTIVITY DATA COUNTRY YEAR Treatment type MAR PARTNER ACTIVITIES Frozen/cryo embryo UNITS/EXPLANATIONS IUI IVF/ICSI transfers (FET) # of couples that had at least one treatment cycle intervention (IUI, IVF/ICSI and/or FET) PA a 1 # of couples treated completed # of cycles without ovarian stimulation (includes hormone substituted cycles) that ended up with PA a 2 # of treatment cycles without stimulation one of the interventions # of cycles with ovarian stimulation (excludes hormone substituted cycles) that ended up with PA a 3 # of treatment cycles with stimulation one of the interventions Numbers (regardless of PARTNER GAMETES/EMBRYOS UNITS/EXPLANATIONS treatment type) PA b 1 # of oocyte retrievals # of retrieval procedures where at least one oocyte was retrieved PA b 2 # of oocytes retrieved # of oocytes retrieved in total PA b 3 # of oocytes cryopreserved # oocytes cryopreserved in total PA b 4 # of sperm collections (including MESA, PESA and TESE) # of collections, regardless of number of straws and method of collection used PA b 5 # of sperm units cryopreserved # of straws/vials PARTNER PROCEDURES PA b 6 # of embryos cryopreserved # of embryos PA b 7 # of embryo transfers (fresh or cryo) # of procedures, regardless of the number of embryos transferred PA b 8 # of embryos transferred (fresh or cryo) # of embryos # of embryos transferred (fresh or cryo) from donated sperm and partner PA b 9 # of embryos oocytes # of embryos transferred (fresh or cryo) from donated oocytes and PA b 10 # of embryos partner sperm DISTRIBUTION AND EXCHANGE OF PARTNER TRANSPORT/DISTRIBUTION IMPORT EXPORT UNITS/EXPLANATIONS GAMETES/TISSUES/EMBRYOS (ACCESS TO CARE) From other EU countries To other EU countries From non-EU countries To non-EU countries PA c 1 # of oocytes # of oocytes PA c 2 # of sperm units # of straws/vials PA c 3 # of embryos # of embryos PA c 4 # of ovarian tissues # of vials/containers PA c 5 # of testicular tissues (including MESA, PESA and TESE) # of vials/containers DELIVERIES AND LIVE BORN CHILDREN (born during the reporting Treatment type UNITS/EXPLANATIONS year regardless of when conceived) IUI IVF/ICSI (fresh or cryo) PA d 1 # of deliveries # of deliveries regardless of the number of children born (including stillborn) PA d 2 # of live born children # of infants with any vital signs PA/PH/TO (21) 02 12 of 14 Work Package 7 / GA 2018 53 01  Numbers (regardless of NON-PARTNER GAMETES/EMBRYOS UNITS/EXPLANATIONS treatment type) NP a 1 # of oocyte donors for dedicated and split donation cycles # of donors (recruited for the specific purpose of donation), regardless of the number of donations NP a 2 # of oocyte donors of supernumerary oocytes (from partner procedures) # of donors of supernumerary oocytes from partner procedures, regardless of the number of donations NP a 3 # of oocyte retrievals intended for donation (dedicated or split) # of retrieval procedures where at least one oocyte was retrieved NP a 4 # of oocytes donated (dedicated, split or supernumerary) # of oocytes NP a 5 # of oocytes cryopreserved (dedicated, split or supernumerary) # of oocytes NP a 6 # of sperm donors # of donors who provided at least one sample during the year NP a 7 # of sperm collections # of collections, regardless of the number of straws NP a 8 # of sperm units cryopreserved # of straws/vials NP a 9 # of embryos donated # of embryos (supernumerary after partner and non-partner treatments) DISTRIBUTION AND EXCHANGE OF NON-PARTNER TRANSPORT/DISTRIBUTION IMPORT EXPORT UNITS/EXPLANATIONS GAMETES/EMBRYOS (COMMERCIALISATION) From other EU countries To other EU countries From non-EU countries To non-EU countries NP b 1 # of sperm units # of straws/vials NP b 2 # of donated embryos # of embryos Treatment type MAR with non partner SPERM donation UNITS/EXPLANATIONS IUI IVF/ICSI # women who underwent IUI and/or an embryo transfer involving donated sperm (in the reporting NP c 1 # of recipients country) NP c 2 # of treatment cycles with donated sperm # of cycles, with or without ovarian stimulation, where donated sperm was used NP c 3 # of partner oocyte retrievals # of retrieval procedures where at least one oocyte was retrieved NP c 4 # of embryos cryopreserved # of embryos (cryopreserved) from donated sperm NP c 5 # of embryo transfers (fresh or cryo) # of transfer procedures involving donated sperm, regardless of the number of embryos transferred NON-PARTNER PROCEDURES NP c 6 # of embryos transferred (fresh or cryo) # of embryos (transferred) from donated sperm MAR with non partner OOCYTE donation IVF/ICSI UNITS/EXPLANATIONS NP d 1 # of recipients # women who underwent at least one embryo transfer involving donated oocytes (in the reporting country) NP d 2 # of treatment cycles with donated oocytes # of cycles, stimulated or non-stimulated, where donated oocytes were used NP d 3 # of partner sperm collections # of collections, regardless of the number of straws NP d 4 # of embryos cryopreserved # of embryos (cryopreserved) from donated oocytes NP d 5 # of embryo transfers (fresh or cryo) # of procedures involving donated oocytes, regardless of the number of embryos transferred NP d 6 # of embryos transferred (fresh or cryo) # of embryos (transferred) from donated oocytes MAR with non partner OOCYTES AND SPERM donation IVF/ICSI UNITS/EXPLANATIONS (double donation) NP e 1 # of recipients # women who underwent at least one embryo transfer involving donated oocytes and sperm (in the reporting country) NP e 2 # of treatment cycles with donated oocytes and sperm # of cycles, stimulated or non-stimulated, where donated oocytes and sperm were used NP e 3 # of embryos cryopreserved # of embryos (cryopreserved ) from donated oocytes and sperm Work Package 7 / GA 2018 53 01 13 of 14 PA/PH/TO (21) 02  NP e 4 # of embryo transfers (fresh or cryo) # of procedures involving donated oocytes and sperm, regardless of the number of embryos transferred NP e 5 # of embryos transferred (fresh or cryo) # of embryos (transferred) from donated oocytes and sperm MAR with EMBRYO donation IVF/ICSI UNITS/EXPLANATIONS (supernumerary from partner or non-partner treatments) NP f 1 # of recipients # women who underwent at least one embryo transfer involving donated supernumerary embryos (in the reporting country) NP f 2 # of treatment cycles with donated embryos # of cycles, stimulated or non-stimulated, where donated supernumerary embryos were used NP f 3 # of embryo transfers (fresh or cryo) # of procedures involving donated supernumerary embryos regardless of the number of embryos transferred NP f 4 # of embryos transferred (fresh or cryo) # of embryos (transferred) from donated supernumerary embryos DELIVERIES AND LIVE BORN CHILDREN Treatment type UNITS/EXPLANATIONS (during the reporting year regardless of when conceived) IUI IVF/ICSI (fresh or cryo) NP g 1 # of deliveries # of deliveries, regardless of the number of children born (including stillborn) NP g 2 # of live born children # of infants with any vital signs FERTILITY PRESERVATION Numbers UNITS/EXPLANATIONS FP a 1 # of patients who underwent one or more oocyte retrievals # of patients who underwent at least one oocyte retrieval procedure, regardless of the number of oocytes retrieved FERTILITY PRESERVATION FP a 2 # of oocyte retrieval procedures # of oocyte retrieval procedures, regardless of the number of oocytes retrieved # of patients who underwent one or more sperm collections (including # of patients who underwent at least one sperm collection procedure (including MESA, PESA and TESE with mature sperm FP a 3 MESA, PESA and TESE) extracted), regardless of the amount of straws/vials obtained # of sperm collection procedures (including MESA, PESA and TESE with mature sperm extracted), regardless of the amount of FP a 4 # of sperm collection procedures (including MESA, PESA and TESE) straws/vials obtained FP a 5 # of patients who underwent an ovarian tissue collection # of patients who underwent an ovarian tissue collection procedure, regardless of the amount of tissue collected FP a 6 # of ovarian tissue collection procedures # of ovarian tissue collection procedures, regardless of the amount of tissue collected # of patients who underwent a collection procedure of immature testicular tissue (i.e. not containing sperm), regardless of the FP a 7 # of patients who underwent a collection of immature testicular tissue amount of tissue collected FP a 8 # of immature testicular tissue collection procedures # of immature testicular tissue collection procedures, regardless of the amount of tissue collected FP a 9 # of patients who underwent an ovarian tissue transplantation # of patients who underwent an ovarian tissue transplantation, regardless of the number of tissue fragments transplanted PA/PH/TO (21) 02 14 of 14 Work Package 7 / GA 2018 53 01