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MAH pour un médicament radiopharmaceutique au Japon
Notice published in French. The AI analysis summarises it for you in your language.
- Public buyer
- Institut National des radioéléments
Fleurus - Place of performance
- 6220 Fleurus, Hainaut
not published: buyer's address - Amount awarded
- €2,141,000 excl. VAT
- Planned end of contract
- 18 February 2030
likely re-tender around August 2029 - Bids received
- 1
- Procedure
- Competitive negotiated procedure
You first submit an application; shortlisted candidates bid, then negotiate with the buyer. - Publication
- 20 February 2026
- Notice language
- French
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Description
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.
Awarded to
CPV codes
European codes that classify what the contract is about. They are how we find the tenders for your trade.
79000000
Winning prices for comparable contracts
- A quarter below
- €253,520
- Median
- €694,000
- A quarter above
- €3,166,661
Amounts awarded (excl. VAT) over the last 3 years for 92 contracts in the same CPV group (7900…), excluding framework agreements. Half of the contracts fall between the two quartiles. TED source: mostly contracts above the EU thresholds, so amounts tend to be high.
Similar contracts already awarded
Source : TED – Office des publications de l'Union européenne © Union européenne, données retraitées. Reference 123384-2026.