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 marketing authorisation, new active substance

Netherlands · Medicines Evaluation Board · New drugs

Full application, new active substanceHigh confidenceLast verified October 3, 2026

Review target

Not published

Legal time limit

210 days

law

Steps

13 requirements

Application fee

€71,000

2026

What is the National marketing authorisation, new active substance in Netherlands?

A national licence from the CBG is valid only for the Netherlands. The CBG must decide within 210 days of receipt, and the clock stops while the company answers questions. The dossier holds pharmaceutical, preclinical and clinical test results. A medicine with an active substance not yet authorised in the EU or EEA, that is not in the mandatory central category and has no licence or pending application in another member state.

How much does the National marketing authorisation, new active substance cost?

The national application, new active substance is €71,000 for 2026.

What are the steps of the National marketing authorisation, new active substance?

1. Request a time slot (21 days); 2. Submit the application; 3. Receipt confirmed; 4. Assessment (210 days); 5. Questions to the company (clock stop); 6. Oral explanation (optional); 7. Decision and licence; 8. Post-approval duties.

Outcome: A national licence with an approved summary of product characteristics, leaflet and pack text. Valid for 5 years.

Legal basis: Geneesmiddelenwet Articles 40 to 47; Regeling Geneesmiddelenwet Chapter 3

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

Steps

In order, with the official target for each step

1. Request a time slot21 daysThe company books a submission slot. The CBG says within three weeks whether the slot is granted.
2. Submit the applicationThe dossier is sent electronically and the fee is due. A national registration number (RVG) is assigned at submission.
3. Receipt confirmedThe CBG confirms receipt in writing within one week.
4. Assessment210 daysThe CBG weighs benefit and risk and decides within 210 days of receipt.
5. Questions to the company (clock stop)clock stopped, only in some casesThe time limit stops while the company has time to send the extra data the CBG asked for.
6. Oral explanation (optional)only in some casesThe company can give an oral explanation of its dossier.
7. Decision and licenceWith a positive decision the product information texts are fixed and the licence is entered in the register.

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
National application, new active substanceApplication · 2026	€71,000

Other routes in Netherlands: 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, Licence for public health reasons (product marketed elsewhere in the EU), 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 (31 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.

Requirements

What the applicant must provide or meet

Eligibility

Only when no central or multi-country route is requiredProducts in the mandatory central category follow the central procedure. If the same dossier of the same applicant is already authorised or under review in another EU or EEA member state, the national route is not possible and mutual recognition is required.

Clinical data

Clinical trial resultsResults of clinical trials with the medicine.

Nonclinical data

Preclinical test resultsResults of preclinical tests.

Quality and manufacturing

Pharmaceutical test resultsResults of pharmaceutical (quality) tests.

Other

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.