Kliinilise uuringu otsus nr RKU-4/72

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

23.09.2024 nr RKU-4/72

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 esitas 19.08.2024 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 Boehringer Ingelheim International GmbH loa ravimi kliinilise

uuringu läbiviimiseks vastavalt esitatud uuringuplaanile nr 1305-0023 järgmistel tingimustel:

uuringuplaani number: 1305-0023 (versioon 4 kuupäevaga 21. september 2023)

uuringu referentsnumber: 22-037

uuringu nimetus: „A double blind, randomized, placebo-controlled trial evaluating the

efficacy and safety of BI 1015550 over at least 52 weeks in patients with Progressive Fibrosing

Interstitial Lung Diseases (PF-ILDs)“

uuringu sponsor: Boehringer Ingelheim International GmbH

uuritavate arv Eestis: 1

vastutavad uurijad ja uuringukeskused:

- Dr Martti Jaanus, North Estonia Medical Centre Foundation, 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

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

teatavaks tegemisest arvates.

Pinar Kilic-Rueger

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim Am Rhein

SAKSAMAA

2 (2)

Lugupidamisega

(allkirjastatud digitaalselt)

Katrin Kiisk

Peadirektor

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

23.09.2024 nr RKU-4/72

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 19.08.2024 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 1305-0023 under the following conditions:

protocol no: 1305-0023 (Version 4, dated September 21, 2023)

full title of the trial: A double blind, randomized, placebo-controlled trial evaluating the

efficacy and safety of BI 1015550 over at least 52 weeks in patients with Progressive Fibrosing

Interstitial Lung Diseases (PF-ILDs)

sponsor of the trial: Boehringer Ingelheim International GmbH

number of subjects in Estonia: 1

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

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.

Pinar Kilic-Rueger

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim Am Rhein

GERMANY

2 (2)

(digitally signed)

Katrin Kiisk

Director General