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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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Compliance specialists discussing Netherlands market requirements

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

Programme design and implementation · Operational shared services · Compliance automation

Use the Pharma Compliance Readiness Checklist →

What we can take on

Pharmaceutical compliance in Netherlands: scope of support

01

Local code interpretation and queries

02

HCP and patient organisation engagement review

03

Local transparency and disclosure requirements

04

Promotional and non-promotional material review

05

Market-entry compliance assessment

06

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.

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.

Tell us what is on your desk.

We will listen, ask a few questions and recommend the right scope—without obligation or pressure.

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