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TED - Tenders Electronic Daily (Publications Office of the EU) verified 1 week ago Contract notice

Belgium - Business services: legal, marketing, consulting, recruitment, printing and security - MAH for a radiopharmaceutical medicine in Japan

Original Belgique - Services aux entreprises: droit, marketing, conseil, recrutement, impression et sécurité - MAH pour un médicament radiopharmaceutique au Japon

Closed Belgium Prov. Hainaut Business services

Buyer Institut National des radioéléments

Key facts

Published
Procedure
Negotiated procedure
  1. Published
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Summary

Machine-generated summary

The buyer is seeking a service provider to act as the Marketing Authorisation Holder (MAH) or local representative in Japan for a Ge/Ga-68 generator, a radiopharmaceutical product. The provider will manage all local regulatory, quality and pharmacovigilance activities for the product, coordinate the registration process through a New Drug Application in line with the requirements of the Japanese Ministry of Health, Labour and Welfare (MHLW) and the PMDA, and maintain the registration thereafter. The scope also includes importing the product into Japan and carrying out its release there.

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.

Official source

Source: TED - Tenders Electronic Daily (Publications Office of the EU)

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Last verified against TED - Tenders Electronic Daily (Publications Office of the EU) 1 week ago

Institut National des radioéléments

Belgium

notices in the register
49
awards
23
awarded in total
€58.9M

Who wins its contracts

Many suppliers
different companies won its awards
18
of the awards went to the three most frequent winners
25%

Based on 20 awards with a named winner over the last 3 years. Counted by award, not by value, because lot and framework amounts are not comparable. Concentrated means the three most frequent winners took 65% or more of the awards; many suppliers, under 35% with at least ten different winners.

Competition

of the awards went to companies based in another country
26%

As the official award notices state them, over the last 3 years. Tenders per lot count open and restricted procedures only: in a negotiated procedure or a direct award a single tender is the procedure itself. The country is the one the notice gives for the winner.

Awards most often to

  1. LEMER PAX 2 awards €7.9M
  2. SERIS TECHNOLOGY 2 awards €758,590
  3. Transnubel 1 award €25.1M

4 open tenders right now

Market context

open now in Business services
4,388
median open notice
€205,000

Who wins in this market

Many suppliers

Belgium · Business services

different companies won awards here
531
of the awards went to the three most frequent winners
2%
buyers awarded contracts here
308

Based on 594 awards with a named winner over the last 3 years. Counted by award, not by value, because lot and framework amounts are not comparable. Concentrated means the three most frequent winners took 65% or more of the awards; many suppliers, under 35% with at least ten different winners.

Competition

tenders per lot on average (open and restricted procedures)
4.8
of those lots received a single tender
12%
of the awards went to companies based in another country
16%
of the tenders came from another country
72%

As the official award notices state them, over the last 3 years. Tenders per lot count open and restricted procedures only: in a negotiated procedure or a direct award a single tender is the procedure itself. The country is the one the notice gives for the winner.

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