Kliinilise uuringu otsus nr RKU-4/82

Nooruse 1 / 50411 Tartu / 737 4140 / [email protected] / www.ravimiamet.ee / Registrikood 70003477

21.10.2024 nr RKU-4/82

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

Mats Heyman

Karolinska University Hospital

Eugeniavagen 3

171 64 Solna

ROOTSI

2 (2)

1 ja § 46 lõikele 1 esitada kaebuse otsuse peale Tartu Halduskohtule 30 päeva jooksul otsuse

teatavaks tegemisest arvates.

Lugupidamisega

(allkirjastatud digitaalselt)

Katrin Kiisk

Peadirektor

Nooruse 1 / 50411 Tartu / 737 4140 / [email protected] / www.ravimiamet.ee / Registrikood 70003477

21.10.2024 nr RKU-4/82

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

Mats Heyman

Karolinska University Hospital

Eugeniavagen 3

171 64 Solna

SWEDEN

2 (2)

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