Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Licence for public health reasons (product marketed elsewhere in the EU) (Gmw Art. 52)

Netherlands · Medicines Evaluation Board · New drugs

Reliance route, recognition or verificationHigh confidenceLast verified October 3, 2026

Review target

Not published

Legal time limit

Not published

Steps

1 requirements

Application fee

What is the Licence for public health reasons (product marketed elsewhere in the EU) in Netherlands?

For public health reasons, the CBG can grant a licence for a medicine that is not on the Dutch market but is on the market in another member state. It is granted to a suitable legal person that agrees. The CBG informs the holder in the other state and can ask that state for its assessment report. A needed medicine available in another member state but not marketed in the Netherlands.

What are the steps of the Licence for public health reasons (product marketed elsewhere in the EU)?

1. CBG informs the holder in the other state; 2. CBG may request the assessment report; 3. Licence granted; 4. European Commission informed.

Does the Licence for public health reasons (product marketed elsewhere in the EU) rely on other regulators?

Yes. It relies on approvals from European Union (recognition).

Outcome: A Dutch licence based on the other member state's authorisation.

Legal basis: Geneesmiddelenwet Article 52 (Directive 2001/83/EC Article 126a)

How the pathway works

Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).

ApplicantRegulatorCertification bodyCommitteeClock stopped

Timeline with clock stops

Official step durations

Steps

In order, with the official target for each step

1. CBG informs the holder in the other state
2. CBG may request the assessment reportonly in some cases
3. Licence granted
4. European Commission informed

Requirements

What the applicant must provide or meet

Eligibility

A legal person that agreesThe licence goes to a legal person the CBG finds suitable and that agrees to it.

Official time targets

Targets, not actual review times

No time targets published.

Fees

Official amounts in the local currency

Fee	Amount
No fees published.

Reliance on other regulators

European UnionRecognitionThe product is on the market in another EU member state but not in the Netherlands.

Other routes in Netherlands: National marketing authorisation, new active substance, National marketing authorisation, known active substance or line extension, National generic or hybrid application, Informed consent application, Duplex marketing authorisation, National well-established use (bibliographic) application, Traditional herbal medicine registration, Parallel import licence, Decentralised procedure: Dutch steps and fees, Mutual recognition and repeat use: Dutch steps and fees, Compassionate use programme, Supply on physician statement (named patient), Temporary import exemption during shortages. See all routes on the or explore them in the .

Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (8 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.