MAH for a radiopharmaceutical product in Japan
Buyer: Institut National des radioéléments
- Published
- 20 February 2026
- Place of performance
- BE32B
- Procedure
- neg-w-call
- Lots
- 1
- Notice number
- 00123384-2026
- Reference
- 573530e5-ef31-4357-a2bf-6c08df662c23
- Official source
- Official source
CPV codes
- 79000000Servicios a empresas: legislación, mercadotecnia, asesoría, selección de personal, imprenta y seguridad
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.
Awards
| Awarded to | Amount | Date |
|---|---|---|
| Global Regulatory Partners Inc. | €2,141,000 | — |
Frequently asked questions
- Who is the buyer of this tender?
- The contracting authority is Institut National des radioéléments (European Union).
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