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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

National well-established use (bibliographic) application

Netherlands · Medicines Evaluation Board · New drugs

Well-established useHigh confidenceLast verified October 3, 2026

Review target

Not published

Legal time limit

210 days

law

Steps

11 requirements

Application fee

What is the National well-established use (bibliographic) application in Netherlands?

When the active substance has been used in the EU or EEA for at least ten years for the requested indication, the company can replace its own preclinical and clinical studies with suitable scientific literature. The CBG decides within 210 days of receipt. Substances with at least ten years of documented medical use in the EU and recognised efficacy and acceptable safety.

What are the steps of the National well-established use (bibliographic) application?

1. Submit bibliographic dossier; 2. Receipt confirmed; 3. Assessment (210 days); 4. Questions (clock stop); 5. Decision.

Outcome: A national licence (RVG number). Valid for 5 years.

Legal basis: Geneesmiddelenwet Article 42(5)(b); Directive 2001/83/EC Article 10a

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

About 210 days end to end with the official step targets. Targets, not actual times.

Steps

In order, with the official target for each step

1. Submit bibliographic dossier
2. Receipt confirmedThe CBG confirms receipt in writing within one week.
3. Assessment210 daysDecision within 210 days of receipt.
4. Questions (clock stop)clock stopped, only in some casesThe time limit stops while the company prepares answers.
5. Decision

Requirements

What the applicant must provide or meet

Clinical data

Scientific literature instead of own studiesSuitable scientific literature shows at least ten years of EU use with recognised efficacy and an acceptable level of safety.

Other

Official time targets

Targets, not actual review times

Legal time limitlaw. Decision within 210 days of receipt. The clock stops while the company prepares answers. This is a legal or official time limit, not an actual review time.

210 days

Fees

Official amounts in the local currency

Fee	Amount
No fees published.

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, Traditional herbal medicine registration, Homeopathic medicine registration, Parallel import licence, Decentralised procedure: Dutch steps and fees, Mutual recognition and repeat use: Dutch steps and fees, Licence for public health reasons (product marketed elsewhere in the EU), Compassionate use programme, Supply on physician statement (named patient). 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 (18 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.

One year of data protection for a new indication

An application for a new indication of a well-known substance can receive one non-cumulative year of data exclusivity if relevant studies were done.

Dossier format: electronic, to CBG specificationsApplication data are sent on an electronic carrier that meets the specifications set by the CBG.

Fee due at submissionThe application fee is owed when the application is submitted, whatever the outcome.

Local presence

Applicant established in the EUThe licence is granted only to a person or company established in the Netherlands or in another EU member state.
National pharmacovigilance contact personWhen the product is on the Dutch market and the EU qualified person for pharmacovigilance lives outside the Netherlands or does not speak, write or read Dutch, a national contact person is also needed. This person must master Dutch. A copy of the pharmacovigilance system master file is due within seven days on request.

Language

Dutch labelling and leafletLabelling and the patient leaflet are clearly legible, in Dutch, easy to understand and indelible. A readability statement form is sent with the application.

Labeling

Packaging mock-upsThe company sends mock-ups of the outer and inner packaging. The pack shows the dispensing category. New medicines show the product name in braille.

After approval

Five-year validity and renewalA licence is valid for five years. The holder sends a consolidated dossier at least nine months before it expires. After renewal the licence is valid without time limit, or once more for five years.
Lapse if not marketedThe licence lapses if the product is not actually on the market for three consecutive years.
Marketing date and supply interruptionsThe holder reports the date the product is actually marketed and gives notice at least two months before marketing is interrupted.