Kliinilise uuringu otsus nr RKU-4/82

Mats Heyman Karolinska University Hospital Eugeniavagen 3 21.10.2024 nr RKU-4/82 171 64 Solna ROOTSI OTSUS Ravimi kliinilise uuringu loa andmiseks Euroopa Parlamendi ja nõukogu määruse (EL) nr 536/2014 (määrus (EL) 536/2014) alusel Uuringu sponsor Karolinska University Hospital esitas 12.09.2024 Ravimiametile taotluse ravimi kliinilise uuringu teostamiseks määruse (EL) 536/2014 artikli 5 (1) ja ravimiseaduse (RavS) § 991 lõikes 1 sätestatud tingimustel. Tuginedes määruse (EL) 536/2014 artiklile 8, hindamisaruande I ja II osaga hõlmatud aspekte hinnates, otsustab Ravimiamet ravimiseaduse § 996 lg 1 punkti 1 ja lõike 3 alusel anda uuringu sponsorile Karolinska University Hospital loa ravimi kliinilise uuringu läbiviimiseks vastavalt esitatud uuringuplaanile nr ALLTogether1 järgmistel tingimustel: uuringuplaani number: ALLTogether1 (Peaprotokoll versioon 5.0, kuupäevaga 14.04.2023) uuringu referentsnumber: 19-053 uuringu nimetus: „ALLTogether1 - A Treatment Study Protocol of the ALLTogether Consortium for Children and Young Adults (0-45 Years of Age) with Newly Diagnosed Acute Lymphoblastic Leukaemia (ALL)“ uuringu sponsor: Karolinska University Hospital uuritavate arv Eestis: 90 vastutavad uurijad ja uuringukeskused: - Dr Mari Punab, Tartu Ülikooli Kliinikum, L. Puusepa tn 1a, 50406 Tartu, Eesti - Dr Kristi Lepik, sihtasutus Tallinna Lastehaigla, Tervise tn 28, 13419 Tallinn, Eesti - Dr Katrin Palk, sihtasutus Põhja-Eesti Regionaalhaigla, J. Sütiste tee 19, 13419 Tallinn, Eesti Vaide käesolevale otsusele saab esitada Ravimiametile 30 päeva jooksul arvates otsuse teatavaks tegemisest vastavalt haldusmenetluse seaduse § 71 lõikele 1. Kui otsuse saaja soovib otsust vaidlustada halduskohtus, võib ta vastavalt halduskohtumenetluse seadustiku § 7 lõikele Nooruse 1 / 50411 Tartu / 737 4140 / [email protected] / www.ravimiamet.ee / Registrikood 70003477 1 ja § 46 lõikele 1 esitada kaebuse otsuse peale Tartu Halduskohtule 30 päeva jooksul otsuse teatavaks tegemisest arvates. Lugupidamisega (allkirjastatud digitaalselt) Katrin Kiisk Peadirektor 2 (2)  Mats Heyman Karolinska University Hospital Eugeniavagen 3 21.10.2024 nr RKU-4/82 171 64 Solna SWEDEN DECISION to grant authorisation for clinical trial on the basis of Regulation (EU) No 536/2014 of the European Parliament and of the council State Agency of Medicines has received the application from sponsor Karolinska University Hospital on 12.09.2024 to conduct a clinical trial under the conditions stipulated in Regulation (EU) No 536/2014 art 5 (1) and § 991 (1) of Estonian Medicinal Products Act (MPA). Based on art 8 of Regulation (EU) No 536/2014, considering the aspects covered by Part I and Part II of the assessment report, on the basis of § 996 section 1 p 1 and (3) of Medicinal Product Act State Agency of Medicines has decided to give the approval to conduct the clinical study protocol no ALLTogether1 under the following conditions: protocol no: ALLTogether1 (Master Protocol Version 5.0, dated 14.04.2023) full title of the trial: ALLTogether1 - A Treatment Study Protocol of the ALLTogether Consortium for Children and Young Adults (0-45 Years of Age) with Newly Diagnosed Acute Lymphoblastic Leukaemia (ALL) sponsor of the trial: Karolinska University Hospital number of subjects in Estonia: 90 principal investigators and study locations: - Dr Mari Punab, Tartu University Hospital, L. Puusepa tn 1a, 50406 Tartu, Estonia - Dr Kristi Lepik, Tallinn Children's Hospital Foundation, Tervise tn 28, 13419 Tallinn, Estonia - Dr Katrin Palk, North Estonia Medical Centre Foundation, J. Sütiste tee 19, 13419 Tallinn, Estonia The addressee may file a challenge with State Agency of Medicines within 30 days as of the day when the addressee became or should have become aware of the decision as prescribed in Code of Administrative Procedure § 71(1). If the addressee wishes to have the decision to annulled by the administrative court, he or she may submit a complaint to the Tartu Nooruse 1 / 50411 Tartu / 737 4140 / [email protected] / www.ravimiamet.ee / Registrikood 70003477 Administrative Court as prescribed in § 7(1) and § 46(1) of the Code of Administrative Court Procedure within 30 days after the date on which the decision was notified to the applicant. (digitally signed) Katrin Kiisk Director General 2 (2)