Kliinilise uuringu otsus nr RKU-4/26

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

23.04.2024 nr RKU-4/26

OTSUS

Ravimi kliinilise uuringu loa andmiseks Euroopa Parlamendi ja nõukogu määruse (EL) nr

536/2014 (määrus (EL) 536/2014) alusel

Uuringu sponsor Boehringer Ingelheim International GmbH, keda käesolevas menetluses

esindab IQVIA RDS Estonia OÜ, esitas 18.12.2023 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 2 ja lõike 3 alusel

anda uuringu sponsorile Boehringer Ingelheim International GmbH loa ravimi kliinilise

uuringu läbiviimiseks vastavalt esitatud uuringuplaanile nr 1305-0031 järgmistel tingimustel:

uuringuplaani number: 1305-0031 (kohalik muudatus 2.0 kuupäevaga 16. aprill 2024)

uuringu referentsnumber: 23-040

uuringu nimetus: „An open-label extension trial of the long-term safety and efficacy of BI

1015550 taken orally in patients with idiopathic pulmonary fibrosis (IPF) and progressive

pulmonary fibrosis (PPF) (FIBRONEER™-ON)“

uuringu sponsor: Boehringer Ingelheim International GmbH

uuritavate arv Eestis: 4

uuringu algus: september 2024

vastutavad uurijad ja uuringukeskused:

- Dr Martti Jaanus, 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

Katrin Peedo

IQVIA RDS Estonia OÜ

Narva mnt 3

51009 Tartu

EESTI

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

23.04.2024 nr RKU-4/26

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 Boehringer Ingelheim

International GmbH on 18.12.2023 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 2 and (3) of Medicinal Product

Act

State Agency of Medicines has decided to give the approval to conduct the clinical study

protocol no 1305-0031 under the following conditions:

protocol no: 1305-0031 (Local Amendment 2.0, dated April 16, 2024)

full title of the trial: An open-label extension trial of the long-term safety and efficacy of BI

1015550 taken orally in patients with idiopathic pulmonary fibrosis (IPF) and progressive

pulmonary fibrosis (PPF) (FIBRONEER™-ON)

sponsor of the trial: Boehringer Ingelheim International GmbH

number of subjects in Estonia: 4

starting date: September 2024

principal investigators and study locations:

- Dr Martti Jaanus, 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

Katrin Peedo

IQVIA RDS Estonia OÜ

Narva mnt 3

51009 Tartu

ESTONIA

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