How medicines and medical devices get approved in Netherlands

One application to the European Medicines Agency leads to one marketing authorisation valid in every EU country. The agency's committee for human medicines gives an opinion within 210 active days. The European Commission then takes the binding decision.

Full application, new active substance · target 210 days · verified October 3, 2026

A full application through the European Medicines Agency for a product whose active substance is already known in the EU. New fixed combinations of known substances also use this type of application, with new data on the combination. The review steps and the 210-day opinion limit are the same as for new active substances.

Full or mixed application, known active substance · target 210 days · verified October 3, 2026

An application based mainly on published scientific literature for an active substance with at least ten years of well-established medicinal use in the EU. When it goes through the European Medicines Agency, the standard centralised steps and the 210-day opinion limit apply.

Well-established use · target 210 days · verified October 3, 2026

For medicines of major public health interest, in particular therapeutic innovation, the committee for human medicines can shorten its review from 210 to 150 days. The applicant asks for it before submitting the application.

Priority or accelerated review · target 150 days · verified October 3, 2026

The EU can authorise a medicine for a seriously debilitating or life-threatening disease before comprehensive clinical data are available, if the benefit of immediate availability outweighs the risk. The holder must complete studies to confirm the benefit. The authorisation lasts one year and is renewed each year.

Conditional or accelerated approval · target 210 days · verified October 3, 2026

The EU can authorise a medicine when comprehensive data on efficacy and safety can never be collected, for example because the disease is very rare. The authorisation carries conditions that are reassessed every year. It normally does not become a standard authorisation.

Approval under exceptional circumstances · target 210 days · verified October 3, 2026

PRIME is a European Medicines Agency scheme that gives early and enhanced support to developers of medicines that target an unmet medical need. Support includes early appointment of a rapporteur, iterative scientific advice and a submission readiness meeting. Products in PRIME can expect to be eligible for accelerated assessment.

Intensive development support designation · verified October 3, 2026

A sponsor can ask for orphan designation for a medicine for a life-threatening or chronically debilitating condition that affects no more than 5 in 10,000 people in the EU, or where sales are unlikely to cover the investment. The Committee for Orphan Medicinal Products gives an opinion within 90 days, and the Commission decides within 30 days. Incentives include protocol assistance, fee reductions and ten years of market exclusivity.

Orphan or rare disease designation · target 90 days · verified October 3, 2026

Applications for new medicines must include results of an agreed paediatric investigation plan, or a waiver or deferral. The Paediatric Committee gives its opinion on a proposed plan within 60 days. Completing an agreed plan can earn a six-month extension of the supplementary protection certificate, or two extra years of market exclusivity for orphan medicines.

Pediatric plan or incentive · target 60 days · verified October 3, 2026

Used to get the same national marketing authorisation in several EU countries at once for a medicine not yet authorised in any of them. One reference member state leads the assessment and the other countries comment and approve. The procedure lasts up to 210 days plus clock stop, followed by 30 days for national decisions.

Work-sharing or joint review · target 210 days · verified October 3, 2026

Used when a medicine already has a national marketing authorisation in one EU country and the holder wants it in other countries. The other countries recognise the existing authorisation based on the reference country's assessment report. Approval takes up to 90 days, then 30 days for national decisions.

Reliance route, recognition or verification · target 90 days · verified October 3, 2026

A medicine outside the mandatory centralised scope can be authorised in a single EU country by its national agency. EU law sets a maximum of 210 days after a valid application. If the same medicine is under review or authorised in another EU country, the decentralised or mutual recognition procedure must be used instead. National fees and details are set by each country.

Other route · verified October 3, 2026

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.

Full application, new active substance · verified October 3, 2026

A national licence for a medicine with an active substance that is already known, or for a line extension of an authorised product. The dossier holds pharmaceutical, preclinical and clinical information. The CBG decides within 210 days of receipt, with clock stops.

Full or mixed application, known active substance · verified October 3, 2026

A company can apply for a licence for a medicine identical to one already on the market by fully referring to the dossier of that reference product. It needs consent from the reference licence holder and supplies only its own administrative data (module 1).

Other route · verified October 3, 2026

A duplex registration is a second licence for a product whose dossier is identical to an already registered product. The CBG can skip a full assessment. Since 1 September 2015 it is open only for products registered at most five years ago with an approved risk management plan, or under extra conditions for older products.

Other route · verified October 3, 2026

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.

Well-established use · verified October 3, 2026

An importer that the original holder did not appoint can bring a medicine from another member state onto the Dutch market. The product must be interchangeable with a Dutch reference medicine. The CBG grants the parallel licence within 45 days. This route does not apply to products with an EU licence from the European Commission.

Other route · verified October 3, 2026

The decentralised procedure is used to obtain a licence in several member states at once. With the Netherlands as reference state, the company books a CBG time slot. After all states agree, the company sends Dutch translations and mock-ups and the CBG issues a national licence. The shared EU steps are described under the EU rules.

Work-sharing or joint review · verified October 3, 2026

In mutual recognition, the reference state has already granted a licence and other states are asked to recognise it. A Dutch national licence can serve as the first phase, with the Netherlands as reference state. The CBG checks whether the dossier is up to date before it goes to other states. The same licence can later be extended to more states through a repeat use procedure.

Reliance route, recognition or verification · verified October 3, 2026

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.

Reliance route, recognition or verification · relies on EU · verified October 3, 2026

A manufacturer can ask the CBG to approve a programme that makes an unlicensed medicine available to a group of patients with a serious disease for which no registered medicine exists. A licence application must be filed or clinical trials must be ongoing. The inspectorate supervises the programme.

Early or compassionate access · verified October 3, 2026

The law forbids supplying a medicine that has no Dutch licence, but the inspectorate (IGJ) can grant an exemption for supply on a physician statement. The physician records why the patient needs the product. A pharmacy, wholesaler, manufacturer or dispensing general practitioner then applies. The legal handling time is up to 8 weeks.

Early or compassionate access · verified October 3, 2026

When a registered medicine is temporarily unavailable, the inspectorate (IGJ) can let manufacturers, wholesalers and dispensers supply an alternative that has no Dutch licence but is authorised in another EU member state, the United Kingdom or a country with a mutual recognition agreement. The exemption is time-limited and published in the government gazette.

Other route · relies on EU, GB · verified October 3, 2026

The CBG and the National Health Care Institute (Zorginstituut) assess at the same time whether a new medicine can enter the Dutch market and the basic insurance package. The company can send its reimbursement dossier before the licence is granted. The CBG states that the total assessment takes about 3 months less than normal. It has been a standard option since February 2022.

Other route · verified October 3, 2026

A biosimilar is a biological medicine highly similar to a reference biological medicine already approved in the EU. The applicant shows similarity through comparability studies and adds the non-clinical and clinical data needed for the differences. The European Medicines Agency reviews it under the same 210-day opinion limit.

Biosimilar application · target 210 days · verified October 3, 2026

A generic application relies on the data of a reference medicine and shows bioequivalence. The European Medicines Agency assesses it when the reference medicine was centrally authorised or the generic brings a significant advantage. Most other generics are authorised nationally.

Generic application · target 210 days · verified October 3, 2026

A hybrid application relies partly on the data of a reference medicine and partly on new studies. It is used when a product is close to a reference medicine but differs, for example in strength, route of administration or indication. Through the European Medicines Agency, the same 210-day opinion limit applies.

Full or mixed application, known active substance · target 210 days · verified October 3, 2026

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.

Generic application · verified October 3, 2026

Every marketing authorisation states whether the medicine needs a prescription. A medicine can be classified as not subject to prescription when it does not meet the prescription criteria. When a switch is approved on the basis of significant new tests or trials, those data are protected for one year against other applicants seeking the same switch. Most non-prescription medicines are authorised at national level.

Non-prescription application · verified October 3, 2026

Herbal medicines with a long tradition can be registered without clinical proof of efficacy. Efficacy is based on long use and experience. The product must have been used for at least 30 years, including at least 15 years in the EU, for use without a doctor.

Traditional or herbal registration · verified October 3, 2026

Homeopathic products for oral or external use, with no therapeutic indication and a high dilution, are registered without preclinical or clinical data. Products with a self-care indication must show that the homeopathic use is described in homeopathic literature.

Other route · verified October 3, 2026

When it grants a licence, the CBG also decides the dispensing category: prescription only (UR), pharmacy only (UA), pharmacy and drugstore (UAD) or general sale (AV). For EU-licensed products that are not prescription only, the CBG sets the Dutch category. The category is shown on the pack.

Non-prescription application · verified October 3, 2026

Blood products and certain vaccines and other immunological medicines may only be supplied after the national institute RIVM has released the batch. The decision is due within 60 days. A batch tested and certified by the authority of another member state does not need Dutch release, but the certificate is sent to the Minister.

Other route · relies on EU · verified October 3, 2026

Gene therapies, somatic cell therapies and tissue engineered products must use the centralised procedure. The Committee for Advanced Therapies prepares the draft opinion, and the committee for human medicines adopts the final opinion. The European Commission decides.

Full application, new active substance · target 210 days · verified October 3, 2026

Advanced therapy medicines normally need an EU licence. A hospital exemption allows custom-made preparation for an individual patient, on a non-routine basis, used in a Dutch hospital under a physician's responsibility. The inspectorate (IGJ) must approve preparation and use and checks that traceability, pharmacovigilance and quality match licensed products.

Other route · verified October 3, 2026

When a device includes a substance that would be a medicine on its own and supports the device's action, the device is class III. The notified body must ask a medicines authority, or the European Medicines Agency, for a scientific opinion on the substance. The authority gives its opinion within 210 days of receiving all documents.

Device: conformity assessment by a certification body · verified October 3, 2026

When a device and a medicine form a single integral product meant only for use in that combination and not reusable, such as a prefilled syringe, the whole product is authorised under medicines law. The device part must meet the general safety and performance requirements of the medical devices regulation. If the device alone would need a notified body, the dossier includes a notified body opinion on the device part.

Other route · target 210 days · verified October 3, 2026

When a device contains a substance that would be a medicine on its own, the notified body must ask a medicines authority for advice. The CBG can act as that authority. It advises on the quality, safety and benefit-risk of the substance. The notified body decides, but it may not issue a certificate after a negative opinion.

Other route · verified October 3, 2026

Makers of class I medical devices declare conformity themselves after preparing the technical documentation. No notified body is involved, except for sterile, measuring and reusable surgical class I devices. The device is registered in the EU database before it is placed on the market.

Device: exempt or self-declared · verified October 3, 2026

Class I devices that are sterile, have a measuring function or are reusable surgical instruments need limited notified body involvement. The notified body checks only sterility, metrology or reuse aspects, under Annex IX Chapters I and III or Annex XI Part A.

Device: conformity assessment by a certification body · verified October 3, 2026

Class IIa devices need a notified body. The usual route is a quality management system audit with assessment of the technical documentation for at least one representative device per category. An alternative route combines technical documentation with product conformity verification.

Device: conformity assessment by a certification body · verified October 3, 2026

Class IIb devices need a notified body audit of the quality management system and assessment of technical documentation. For most class IIb implantable devices, the technical documentation of every device is assessed. Class IIb active devices that administer or remove medicines go through an extra expert panel consultation.

Device: conformity assessment by a certification body · verified October 3, 2026

Class III devices need a full notified body assessment, with the technical documentation of each device reviewed. Clinical investigations are generally required for class III and implantable devices. For class III implantable devices, the notified body consults an expert panel on its clinical evaluation assessment.

Device: conformity assessment by a certification body · verified October 3, 2026

Devices and IVDs follow the EU regulations. Only a few matters, such as supervision and the language of the instructions, are set nationally. Economic operators register in EUDAMED, and for Dutch actors the CIBG/Farmatec checks the request and issues the single registration number. The inspectorate (IGJ) supervises the market and receives incident reports until EUDAMED is ready.

Device: registration or licence with the regulator · verified October 3, 2026

The EU rules let a national authority allow a device or IVD on its market without the normal conformity assessment. In the Netherlands such an exemption can be granted with limits and conditions, is announced in the government gazette, and can be withdrawn.

Other route · verified October 3, 2026

Makers of class A in vitro diagnostic devices declare conformity themselves after preparing the technical documentation. Class A devices sold sterile need a notified body for the sterility aspects.

Device: exempt or self-declared · verified October 3, 2026

Class B in vitro diagnostic devices need a notified body audit of the quality management system and assessment of technical documentation for at least one representative device per category of devices. Self-tests and near-patient tests also get a technical documentation assessment.

Device: conformity assessment by a certification body · verified October 3, 2026

Class C in vitro diagnostic devices need a notified body audit of the quality management system and assessment of technical documentation for at least one representative device per generic device group. Self-tests and near-patient tests also get a technical documentation assessment. Companion diagnostics also need a medicines authority opinion.

Device: conformity assessment by a certification body · verified October 3, 2026

Class D in vitro diagnostic devices get the strictest assessment. The notified body reviews the quality system and technical documentation. Where an EU reference laboratory is designated, it verifies the claimed performance by laboratory testing and gives a scientific opinion within 60 days. For a first certification without common specifications, expert panels review the performance evaluation.

Device: conformity assessment by a certification body · verified October 3, 2026

Software is a medical device when the maker intends it for a medical purpose. It follows the same rules as other devices or IVDs. Rule 11 places software that informs diagnosis or treatment decisions in class IIa, IIb or III by the possible impact on health, and other software in class I. The class then decides the conformity assessment route.

Device: conformity assessment by a certification body · verified October 3, 2026