AwardedBelgiumServices
MAH pour un médicament radiopharmaceutique au Japon
- Published
- Published 4 August 2025
Overview
Agir en tant que titulaire de l'autorisation de mise sur le marché (MAH ou représentant local) au Japon et gérer toutes les activités réglementaires, de qualité et de pharmacovigilance locales pour le générateur Ge/Ga-68 (le produit). Coordonner le processus d'enregistrement (New Drug Application « NDA ») du produit au Japon conformément aux réglementations et normes du MHLW (ministère de la Santé, du Travail et des Affaires sociales) et de la PMDA (Agence des produits pharmaceutiques et des dispositifs médicaux), ainsi que maintenir l’enregistrement. Importer et libérer le produit au Japon.
Key details
- Country
- Belgium
- Status
- Awarded
- Category
- Services
- Procedure
- Limited
- Published
- 4 August 2025
Business services: law, marketing, consulting, recruitment, printing and security
Award outcome
- Awarded value
- €2,141,000
- Award date
- 18 February 2026
- Contract period
- 18 February 2026 → 17 February 2030
- Global Regulatory Partners Inc.
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Notice history
Every published notice in this contracting process, newest first.
Contract Award Notice
20 February 2026
Contract Notice
4 August 2025
Contracting authority
Institut National des radioéléments
Procuring entityFleurus, Belgium
Authority website ↗
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