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MAH for a radiopharmaceutical product in Japan

Institut National des radioéléments
31/07/2025
Afdeling I: Aanbestedende dienst
Institut National des radioéléments

Avenue de l’Espérance 1, 6220 Fleurus, Belgium
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Afdeling II: Voorwerp
5bbb7016-5dbf-42c1-b861-fb4fdc7491bf
F02

MAH for a radiopharmaceutical product in Japan
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.
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.

UNKNOWN
  • 100 (quality) :
    Voir guide de sélection/cahier des charges
    See selection guide/specifications
BE32B BEL
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