Kliinilise uuringu otsus nr RKU-4/32

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

20.05.2024 nr RKU-4/32

OTSUS

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

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

Uuringu sponsor GlaxoSmithKline Biologicals esitas 09.04.2024 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 GlaxoSmithKline Biologicals loa ravimi kliinilise uuringu

läbiviimiseks vastavalt esitatud uuringuplaanile nr 215336 järgmistel tingimustel:

uuringuplaani number: 215336 (Muudatus 6 kuupäevaga 5. oktoober 2023)

uuringu referentsnumber: 22-018

uuringu nimetus: „A Phase I/II, observer-blind, randomised, placebo-controlled, multi-

country study to evaluate reactogenicity, safety, immune response, and efficacy of an HSV-

targeted immunotherapy in healthy participants aged 18-40 years or in participants aged 18-

60 years with recurrent genital herpes.“

uuringu sponsor: GlaxoSmithKline Biologicals

uuritavate arv Eestis: 20

vastutavad uurijad ja uuringukeskused:

- Dr Airi Põder, Kliiniliste Uuringute Keskus OÜ, Sõbra tn 54/1, 50106 Tartu, 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.

Derek Moriarty

GlaxoSmithKline Biologicals

12 River Walk, Citywest Business Campus

D24 YK11 Dublin

IIRIMAA

2 (2)

Lugupidamisega

(allkirjastatud digitaalselt)

Katrin Kiisk

Peadirektor

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

20.05.2024 nr RKU-4/32

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 GlaxoSmithKline

Biologicals on 09.04.2024 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 215336 under the following conditions:

protocol no: 215336 (Amendment 6, dated October 5, 2023)

full title of the trial: A Phase I/II, observer-blind, randomised, placebo-controlled, multi-

country study to evaluate reactogenicity, safety, immune response, and efficacy of an HSV-

targeted immunotherapy in healthy participants aged 18-40 years or in participants aged 18-

60 years with recurrent genital herpes.

sponsor of the trial: GlaxoSmithKline Biologicals

number of subjects in Estonia: 20

principal investigators and study locations:

- Dr Airi Põder, Kliiniliste Uuringute Keskus OÜ, Sõbra tn 54/1, 50106 Tartu, 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.

Derek Moriarty

GlaxoSmithKline Biologicals

12 River Walk, Citywest Business Campus

D24 YK11 Dublin

IRELAND

2 (2)

(digitally signed)

Katrin Kiisk

Director General