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 generic or hybrid application

Netherlands · Medicines Evaluation Board · Generics

Generic applicationHigh confidenceLast verified October 3, 2026

Review target

Not published

Legal time limit

210 days

law

Steps

15 requirements

Application fee

€37,290

2026

What is the National generic or hybrid application in Netherlands?

A generic refers to the data of a reference medicine instead of its own preclinical and clinical trials. A true generic shows equal availability in the body with studies. A hybrid supports its differences with relevant studies. The generic cannot be marketed until ten years after the reference product was authorised. A copy of a reference medicine authorised in the EU for at least eight years, sold only in the Netherlands.

How much does the National generic or hybrid application cost?

The national application, known active substance (fee type used for generics) is €37,290 for 2026.

What are the steps of the National generic or hybrid application?

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. Decision and licence; 7. Post-approval duties.

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

Legal basis: Geneesmiddelenwet Articles 42(5)(a), 42(6) and 43; Directive 2001/83/EC Article 10(1) and 10(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. Decision and licenceWith a positive decision the product information texts are fixed and the licence is entered in the register.
7. Post-approval dutiesMarketing notices, pharmacovigilance and renewal after five years.

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, known active substance (fee type used for generics)Application · 2026	€37,290

Other routes in Netherlands: National marketing authorisation, new active substance, National marketing authorisation, known active substance or line extension, 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 (30 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.

Eligibility

Reference product authorised for at least eight yearsOwn preclinical and clinical results are not needed when the product is a generic of a reference medicine authorised in the EU at least eight years before the application.

Clinical data

BioequivalenceStudies show equal availability in the body compared with the reference medicine.
Hybrid applications(in some cases)When the product differs from the reference (for example strength, form, route or indication), or bioequivalence cannot be shown, bridging study results are sent.

Quality and manufacturing

Same composition and formSame qualitative and quantitative composition of active substances and the same pharmaceutical form as the reference medicine.

Other

Market protection of the referenceThe generic is not marketed until ten years after the reference was authorised, or up to eleven years if a new indication with significant clinical benefit was added within eight years.
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.

Labeling

Patented indications(in some cases)Where use patents apply, the holder can remove the patented indication from the product information, so it is not part of the licence.
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.

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.

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.

National generic or hybrid application

What is the National generic or hybrid application in Netherlands?

How much does the National generic or hybrid application cost?

What are the steps of the National generic or hybrid application?

How the pathway works

Timeline with clock stops

Steps

Official time targets

Fees

Requirements

Eligibility

Clinical data

Quality and manufacturing

Other

Labeling

Local presence

Language

After approval