ClosedServicesOnderhandeling zonder bekendmaking

Voluntary prior transparency for external support for obtaining a marketing authorisation (MA) – also known as a trading licence – for the production of FDG in the UMCG

Name: Voluntary prior transparency for external support for obtaining a marketing authorisation (MA) – also known as a trading licence – for the production of FDG in the UMCG
Creator: Universitair Medisch Centrum Groningen (UMCG) / Poliklinische Apotheek UMCG
Published: 2025-12-12
License: https://creativecommons.org/publicdomain/zero/1.0/
Keywords: FDG, marketing authorisation, MA, PET diagnostics, consultancy

Universitair Medisch Centrum Groningen (UMCG) / Poliklinische Apotheek UMCG · Onderhandeling zonder bekendmaking · 1 lots · 405024

0 of 6 core insights found

Measures presence, not accuracy · documents remain authoritative

ScopeAdvicePoints of attentionSuitability requirementsAward criteriaTimeline

Type

Services

79419000 · Evaluation advisory se

Estimated value

€ 200K

estimated

To deadline

Ongoing

Knock-outs

n/a

exclusion grounds

Award basis

Best price-quality ratio

Assess manuallyconfidence low

The University Medical Center Groningen (UMCG) is seeking external support for the market registration of a marketing authorisation (MA) to continue the internal and external production of FDG—a radioactive tracer for PET diagnostics. The assignment is an evaluation advisory service (CPV 79419000-4) and is concluded via a negotiation without publication, without a specified deadline or contract value. As only one firm (3D-PharmXchange) reports the necessary expertise, the chance of a rapid decision is increasing, and it is in principle suitable for SME bidders, albeit with a preference for a (large) consultancy firm with experience in pharmaceutical MA processes.

Services · Onderhandeling zonder bekendmaking · National procedure

Contracting authority

Universitair Medisch Centrum Groningen (UMCG) / Poliklinische Apotheek UMCG

Contract type

Services

Onderhandeling zonder bekendmaking

Estimated value

€200,000

estimated value

Submission deadline

Ongoing

Scope

National

National procedure

Lots

1 lots

Main CPV code

79419000

Evaluation advisory services

Location

Netherlands

CharacteristicsCPV 79ServicesFDGmarketing authorisationMA

01What is being requested

The University Medical Center Groningen (UMCG) is seeking external support for the market registration of a marketing authorisation (MA) to continue the internal and external production of FDG—a radioactive tracer for PET diagnostics. The assignment is an evaluation advisory service (CPV 79419000-4) and is concluded via a negotiation without publication, without a specified deadline or contract value. As only one firm (3D-PharmXchange) reports the necessary expertise, the chance of a rapid decision is increasing, and it is in principle suitable for SME bidders, albeit with a preference for a (large) consultancy firm with experience in pharmaceutical MA processes.

FDG (Fluorine-18 fluorodeoxyglucose) is an indispensable radioactive tracer for PET diagnostics at the UMCG. It assists in detecting and monitoring oncological, neurological, and cardiovascular conditions. Approximately 7,200 patient doses of FDG are produced annually and used for diagnostics. Due to the aging population and an increase in cancer diagnoses, the demand for FDG PET scans is expected to increase further. This makes stable and reliable production of FDG essential for both patient care and scientific research.激激激激激激激激激激激激激激激激激激激激激激激激激激激激激激激激激激激激激激激激激激激激激激激激激激激激激激激激激激激激激激激激激激激激激激激激激

79419000€ 200KServices

1Voluntary prior transparency for external support for obtaining a marketing authorisation (MA) – also known as a trading licence – for the production of FDG in the UMCG€200,000

02Value in context

€200,000

03Likely competitors

#Likely bidderFitWins

1Maandag Interim Professionals B.V.SME60387×

2Daan B.V.SME60154×

3Randstad Uitzendbureau b.v.SME60135×

4Bender Detachering B.V.SME60107×

5Unique Nederland B.V.SME60103×

6Driessen B.V.SME6097×

04Legal themes that may be relevant here

Advies 451> Beklaagden hebben op 29 mei 2017 een Europese openbare aanbestedingsprocedure aangekondigd voor een raamovereenkomst per perceel Advies 424> Beklaagde heeft mede namens vier andere organisaties een Europese openbare procedure aangekondigd voor raamovereenkomsten met ééComplaint dismissed Advies 442> Europese openbare procedure voor een overheidsopdracht voor werken voor het ontwerpen en uitvoeren van integraal groot onderhoudComplaint upheld Advies 458> Nationale openbare aanbesteding voor een overheidsopdracht voor werken voor het groot onderhoud van een provinciale weg waaronde Advies 353> Op grond van art. 2.98, lid 2, Aw 2012 mag de aanbestedende dienst eisen dat gegadigde over de benodigde vergunning en een certi

05Frequently asked questions

What is the purpose of this assignment?

The assignment concerns external support for the registration process for a marketing authorisation (MA) for the production of FDG. This process includes guidance up to and including the submission to the Medicines Evaluation Board (CBG).

Why is a marketing authorisation (MA) necessary for FDG production?

Due to the annual production of approximately 7,200 patient doses, FDG production does not fall under magistral preparation. Consequently, the UMCG must comply with the rules for industrial production of medicinal products and possess the appropriate licences.

What is the function of FDG in the care provided by the UMCG?

FDG (Fluorine-18 fluorodeoxyglucose) is a radioactive tracer used for PET diagnostics in detecting and monitoring oncological, neurological, and cardiovascular conditions.

What results emerged from the market consultation?

The market consultation via a questionnaire on Mercell revealed that only the firm 3D-PharmXchange possesses the necessary expertise to guide the UMCG in the registration process for the production of FDG.

Automatically compiled from the official tender data and documents.

06Estimated value versus the market

p25
€ 200K

median
€ 640K

p75
€ 3,0 mln

€ 200K

Gegunde waarden in CPV 79 · diensten n=4949