
Pharmaceutical compliance support in the Netherlands
Local rules, connected to your global model.
Eunomia helps pharmaceutical and biotech teams plan compliance support for activities in the Netherlands, connecting Dutch inducement and advertising rules, the CGR code and Transparantieregister Zorg reporting with your global governance. We agree the expertise and scope needed before work begins.
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Who this support is for
For international pharmaceutical and biotech companies with Dutch activities, Benelux or Northern European teams, and companies preparing a Dutch launch. Start with the HCP engagements, materials and payments you plan in the Netherlands.
The practical challenge in Netherlands
Dutch inducement rules are statutory and apply to both the giver and the receiver. The IGJ policy rules set specific limits for low-value gifts, and financial relationships above a threshold are published in the Transparantieregister Zorg on a fixed annual timetable. Global processes need these limits and dates built in.
How Eunomia can help
We can scope a gap assessment against the Geneesmiddelenwet, the IGJ policy rules and the CGR code, and build the result into your SOPs, review routes and reporting process. Outputs can include an activity register, a responsibility matrix and a prioritised action plan. Where Dutch legal advice, Dutch-language review or a formal role is required, we identify that need and confirm appropriate expertise before delivery.
Your first working priorities
- Check planned gifts and hospitality against Article 94 of the Geneesmiddelenwet and the IGJ value limits.
- Put written agreements and reasonable-fee rationale in place for every paid HCP service.
- Decide which planned materials or activities to submit to the CGR for preliminary advice.
- Prepare Transparantieregister Zorg data ahead of the 1 June reporting deadline, with a named owner.
Programme design and implementation · Operational shared services · Compliance automation
What we can take on
Pharmaceutical compliance in Netherlands: scope of support
HCP and patient organisation engagement review
Local transparency and disclosure requirements
Promotional and non-promotional material review
Market-entry compliance assessment
Specialist and language requirements assessment
What this gives you
Netherlands requirements built into your global processes
Clear responsibilities for review and escalation
Local support without unnecessary fixed headcount
The rules in Netherlands
What shapes compliance in Netherlands…
A short guide to the main legal and self-regulatory frameworks. Each summary links to its official source below.
Inducements: Article 94 of the Geneesmiddelenwet
Chapter 9 of the Medicines Act (Geneesmiddelenwet) governs medicines advertising. Article 94 prohibits inducements (gunstbetoon) aimed at promoting the prescribing, dispensing or use of a medicine, with four exceptions: services under a written agreement at a reasonable fee, hospitality at meetings limited to what is strictly necessary, low-value gifts relevant to practice, and purchase discounts and bonuses.
IGJ policy rules and supervision
The Health and Youth Care Inspectorate (IGJ) supervises the advertising and inducement rules. Its Beleidsregels gunstbetoon Geneesmiddelenwet 2018, in force since 1 April 2018, set low value at €50 per gift with a maximum of €150 a year. The IGJ notes that what a giver may not give, a recipient may not accept.
Advertising restrictions
Public advertising of prescription-only medicines is prohibited (Article 85). Free samples of prescription-only medicines are allowed only under strict conditions, including no more than two samples of the same medicine per healthcare professional per calendar year (Article 92).
Self-regulation: the CGR code
The Stichting Code Geneesmiddelenreclame (CGR) runs self-regulation of advertising aimed at healthcare professionals through the Gedragscode Geneesmiddelenreclame, under IGJ oversight. Oversight sits with the CGR’s Keuringsraad, Codecommissie and Commissie van Beroep. The Keuringsraad gives non-binding preliminary advice on planned activities within 30 working days; some activities require mandatory preventive review.
Transparantieregister Zorg
The register publishes financial relationships of at least €500 per calendar year between companies and healthcare professionals, institutions and patient organisations, including service fees, sponsorship and individual hospitality. Companies report before 1 June of the following year, recipients can check the data, and it is published in mid-July.
Public advertising review: KOAG/KAG
The Keuringsraad KOAG/KAG supervises public advertising for medicines on behalf of the industry, under IGJ oversight. It reviews self-care medicine advertising in advance against the Code voor de Publieksreclame voor Geneesmiddelen, and approved advertising receives an approval number, normally valid for one year.
Primary references
This overview is informational and does not constitute legal advice. Scope and application should be confirmed for the organisation, market, activity and counterparty in question. Sources checked September 2026.
Questions, answered
Pharmaceutical compliance in Netherlands FAQs
What counts as a low-value gift in the Netherlands?
The IGJ policy rules set low value at €50 per gift, with a maximum of €150 per year. Gifts must also be relevant to the professional’s practice under Article 94 of the Geneesmiddelenwet.
What must be reported to the Transparantieregister Zorg?
Financial relationships of at least €500 per calendar year with healthcare professionals, institutions or patient organisations, such as service fees, sponsorship and individual hospitality. Companies report before 1 June of the following year and the data is published in mid-July. Clinical trials under the WMO are excluded.
Can the CGR check our plans in advance?
Yes. The CGR Keuringsraad gives non-binding preliminary advice on planned materials and activities, within 30 working days. Some activities require mandatory preventive review.
Does Eunomia have a named consultant based in the Netherlands?
This page does not identify a Netherlands-based consultant. Contact our UK-based team to agree the activities, expertise and delivery arrangements needed. Any local specialist, Dutch-language review or formal role must be confirmed as part of the engagement.
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