GPC Gov : Public tenders - MAH for a radiopharmaceutical product in Japan

MAH for a radiopharmaceutical product in Japan

Institut National des radioéléments

Dispatch date: 31/07/2025

Section I: Contracting authority

Official name: Institut National des radioéléments
National registration number:
Address: Avenue de l’Espérance 1, 6220 Fleurus, Belgium

Contact person: *********
Phone: *********
Email:*********

Section II: Object

Reference number: 5bbb7016-5dbf-42c1-b861-fb4fdc7491bf

BDA No: F02

II.1.1) Title: MAH for a radiopharmaceutical product in Japan
II.1.4) Short description: Act as Marketing Authorization Holder (MAH ou local representative) in Japan and handle all local regulatory, quality and pharmacovigilance activities for the Ge/Ga-68 Generator (the product). Coordinate the registration process (New Drug Application “NDA”) of the product in Japan in compliance with MHLW (Ministry of Health, Labour and Welfare) and PMDA (Pharmaceuticals and Medical Devices Agency) regulations and standards and maintain the registration. Import and release the product in Japan.

Lot 1 : CT25-247 - 1

Act as Marketing Authorization Holder (MAH ou local representative) in Japan and handle all local regulatory, quality and pharmacovigilance activities for the Ge/Ga-68 Generator (the product). Coordinate the registration process (New Drug Application “NDA”) of the product in Japan in compliance with MHLW (Ministry of Health, Labour and Welfare) and PMDA (Pharmaceuticals and Medical Devices Agency) regulations and standards and maintain the registration. Import and release the product in Japan.

Start : UNKNOWN

II.2.5) Award criteria:

100 (quality) :
Voir guide de sélection/cahier des charges
See selection guide/specifications

NUTS

BE32B BEL

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