Netherlands Pharmaceutical Licensing

This record covers only human medicinal products within the Netherlands. Dispensing by pharmacies to patients, wholesale between companies, manufacturing or importing from third countries, active pharmaceutical ingredients (API), medicinal product brokering, product marketing and controlled drugs are distinct regulatory routes. Companies should not interpret any one route as automatically authorising the others.

The definitions of manufacturers and wholesalers in the Medicines Act require them to be natural or legal persons established and licensed in the Netherlands. The materials reviewed do not set out any generally applicable foreign ownership percentage, minimum registered capital or mandatory company form; no such assertions are therefore made. The Netherlands is not a federal state, but this record has not verified municipal planning, construction, fire safety, environmental or general business formalities.

Farmatec is part of CIBG and handles F/G licences and exemptions for controlled medicines; IGJ supervises manufacturers under GMP and wholesalers under GDP.

Prescription medicines may only be obtained from a pharmacy and must be dispensed by a pharmacist. A public pharmacy must at all times have a pharmacist registered in IGJ’s register of established pharmacists; otherwise, pharmacists at that pharmacy may not dispense prescription medicines to patients. The register records the pharmacy address and is updated weekly by IGJ.

Over-the-counter medicines are not all restricted to pharmacies: UA medicines may be sold only in pharmacies, UAD medicines may be sold in pharmacies or drugstores, and AV medicines may be sold by general retailers. Businesses selling medicines online must also register with Online Aanbieders Medicijnen; eligible suppliers are included in the online suppliers list and use the mandatory European logo.

A wholesale licence is required to obtain and supply medicines from within the EEA. Farmatec generally classifies obtaining medicines from outside the EEA as an activity requiring a manufacturer’s licence. Once an application is complete, Farmatec sends an acknowledgement of receipt, forwards it to IGJ for consultation, and then makes a decision; if the application is incomplete, the applicant will be asked to provide the missing information within six weeks.

GDP is central to the quality system for storage, transport and distribution. IGJ inspects new wholesale applicants and conducts risk-based inspections of businesses holding a G licence; verification of safety features on prescription-medicine packaging and controls against falsified medicines are also relevant obligations for wholesalers.

The manufacture of medicines, in whole or in part, packaging, labelling, and importation from outside the EEA are all activities covered by a manufacturer’s licence. An F licence also covers the supply and export of medicines manufactured or imported by the licence holder; this does not mean that any product without a marketing authorisation may be sold.

IGJ supervises manufacturers of human medicines and active substances under GMP. A manufacturer must appoint a QP; the QP has particular responsibility for batch certification and confirming, before release, compliance with GMP and the marketing authorisation/research dossier, while the business remains responsible for overall quality.

The individual pharmacist pathway is separate from business licensing. To work as a pharmacist in the Netherlands, BIG registration is required; the person responsible for a public pharmacy must also be entered in IGJ’s register of established pharmacists. Recognition of foreign qualifications, any supplementary education and BIG registration for holders of foreign qualifications must be handled on a case-by-case basis; qualification cannot be inferred solely from an overseas licence or business position.

A manufacturer’s QP is a statutory quality and batch-certification role. The business makes the notification to Farmatec, and IGJ assesses the QP’s education and work experience. A wholesale application requires a qualified person responsible for all wholesale activities and submission of evidence of their responsibilities, the organisational structure and their review of the quality procedures; the pages reviewed do not publish a single educational-qualification list that applies irrespective of specific responsibilities and GDP.

The register of established pharmacists records the pharmacy address. Wholesale licence applications state activities by location, while manufacturing licences are assessed according to actual manufacturing or import activities; locations and activity scope are licence/register information, and changes should not be treated as internal administrative matters only.

Storage and transport at wholesale premises should meet GDP requirements, while manufacturing premises and quality systems should meet GMP requirements; they may be inspected by IGJ during the application process or subsequent supervision. The national materials reviewed do not provide a uniform industry-wide minimum floor area, fixed number of shelves or general building dimensions, so no figures are invented here.

For F/G licences, applicants download, complete and print the form and send it to Farmatec with the required supporting documents. Once the complete application has been acknowledged, Farmatec forwards it to IGJ for an opinion and then makes a decision; if information is missing, the applicant will be asked to provide it within six weeks. Amendments to a manufacturing licence can be made using the same application form; a dedicated amendment form must be used for a wholesale licence.

For retail, the person responsible for a public pharmacy uses the IGJ register amendment form to register, amend or cancel an entry. Online medicine sales require separate registration with Online Aanbieders Medicijnen. Product-level marketing authorisation dossiers must instead be submitted to CBG-MEB or through the applicable EU procedure and cannot be replaced by an F/G licence application.

The Farmatec page states that the F licence application fee is 2,600 euros and the annual fee is 3,200 euros; the G licence application fee is 1,700 euros and the annual fee is 1,600 euros. The statutory decision period for both types of new application and general amendment is 90 days; a specific amendment involving a QP/qualified person has a 30-day period. These are net processing times, excluding periods when the clock is suspended for reasons such as applicant or site readiness. In principle, both types of licence are valid indefinitely.

The national uniform fees, processing times and renewal arrangements for registration of an established pharmacist at a public pharmacy and opening a general pharmacy were not clearly listed on the pages reviewed, so no figures are invented. Fees and validity periods for product marketing authorisations and Opium Act exemptions apply separately.

Although F/G licences are in principle valid indefinitely, this does not mean there are no ongoing obligations. IGJ inspects new wholesale applicants and conducts risk-based GDP inspections of existing wholesalers; manufacturers must continue to comply with GMP. The manufacturing QP should ensure that personnel training, deviation investigations, change assessments, product quality reviews and inspection corrective actions are implemented.

A public pharmacy should continuously maintain a pharmacist registered in the register of established pharmacists, and changes to the responsible person or address should be updated using the IGJ form. Obligations relating to safety features on prescription-medicine packaging, medicine quality and anti-falsification measures in the supply chain should be implemented according to the business’s role.

Changes to manufacturing-licence activities or QPs, etc., are handled using the manufacturing licence application form; changes to a wholesale licence must use Farmatec’s dedicated change form. The wholesale form covers matters such as licensed activities, premises, contract wholesalers and qualified personnel. The person in charge of a public pharmacy may use the IGJ register-change form to update, add or cancel a registration.

The official materials reviewed this time do not provide a single rule generally applicable to all F/G licences or pharmacies covering shareholding changes, mergers and acquisitions, changes of control or automatic licence transfer. Therefore, before a transaction, confirm with Farmatec, IGJ and the relevant local authorities whether an amendment application, new licence, notification or re-verification is required.

Medicines require a marketing authorisation before being placed on the market in the Netherlands. Under the Dutch national procedure, an authorisation granted by CBG-MEB is valid only in the Netherlands, and CBG-MEB assesses the medicine dossier; depending on the product and market scope, the centralised, mutual recognition or decentralised EU procedure may also apply. A first marketing authorisation under the national procedure has a term; after five years, renewal and whether it becomes unlimited are decided again based on the benefit-risk balance. This concerns the product, not the term of an F/G business licence.

Importing medicines from outside the EEA generally requires an F licence; a G licence applies to procurement and supply within the EEA. Manufacture, import or distribution of human APIs requires a separate API registration with Farmatec and is distinct from a G licence for medicines. Medicines brokering also requires separate registration.

Activities involving controlled substances listed in Schedule I or II of the Opium Act, including manufacture, processing, sale, supply, transport and possession, generally require an exemption from Farmatec; imports and exports also require an import/export exemption for each consignment. Applications concerning cannabis, hashish, cannabis oil or their preparations should be handled by the Office of Medicinal Cannabis; an ordinary F/G licence must not be treated as authorisation to handle controlled drugs.