Belgium Pharmaceutical Licensing

This record is limited to public pharmacies, wholesale distribution of medicines, and manufacturing/import from third countries for human medicines. FAMHP treats manufacturing/import authorisation (MIA) and wholesale distribution authorisation (WDA) as separate documents; public pharmacies have separate authorisation to establish and pharmacy registration. Crossroads Bank for Enterprises (CBE) registration is an administrative basis for commencing business and does not replace FAMHP authorisation.

The principal regulation of pharmaceutical business in Belgium is at federal level, but recognition of foreign healthcare professional diplomas is handled by the Flemish, French or German Community according to the language of the application, followed by the federal practice-visa process. The materials reviewed do not establish a uniform system of separate provincial pharmaceutical business licences.

— Plan separately for the company/CBE, pharmacy establishment and registration, WDA, MIA, individual practice, product marketing and controlled-substance activities.

— No generally applicable minimum capital, designated company form or foreign ownership percentage was verified; these must not be presented as pharmaceutical licensing conditions in this country.

— Veterinary medicines, active pharmaceutical ingredients, medical devices, cosmetics and the classification of each traditional/herbal product are outside the core scope of this record.

FAMHP is the federal competent authority for medicines regulation and inspection. Its service page cites articles 12b and 12c of the Medicines Act of 25/3/1964 and the Royal Decree of 14/12/2006 concerning medicinal products for human and veterinary use: articles 74 to 83 cover manufacturing/import, and articles 90 to 99 cover wholesale distribution. Establishment of community pharmacies is governed by the Royal Decree of 16/1/2022.

Professional and business status are not resolved in a single step by the same authority. Community authorities handle recognition/equivalence of foreign diplomas, FPS Public Health issues practice visas, and the CBE, administered by FPS Economy, maintains company and establishment-unit information.

— FAMHP: authorisations for pharmaceutical business activities, pharmacy registration, GMP/GDP and controlled-substance services.

— Communities and FPS Public Health: recognition/equivalence of professional qualifications and individual practice visas.

— CBE: company/establishment-unit registration and identification, not pharmaceutical business approval.

Opening, relocating, merging or closing a public pharmacy requires authorisation to establish. New establishments are authorised by the Minister responsible for public health, but FAMHP states that, due to the moratorium, applications for new establishment authorisations cannot be submitted before 2029. Applications for relocation or merger of existing pharmacies may be made through the published procedure; only the authorisation holder may apply, and a sworn surveyor’s report must be attached.

The procedure comprises, in order, an application, admissibility review and publication, comments/objections, an inspector’s opinion, a decision by the official responsible for establishment matters or the Minister, and registration. FAMHP indicates that this establishment-authorisation procedure takes approximately four to six months; approved matters should be registered promptly, and authorisations to open or relocate must be registered at least 60 days before commencing operations at the proposed premises. The official page states that establishment authorisation expires upon first use or, at the latest, two years after publication; this authorisation must not be confused with the ongoing registration status for operating the pharmacy.

— Registration matters include reopening/closure, merger/relocation, transfer of operating authorisation, changes to the operator and managing pharmacist, adjacent premises, non-prescription medicine websites, and contact details.

— Online supply of non-prescription medicines for human use may be possible only through a website notified to FAMHP and the pharmacists’ association by a licensed pharmacy; this registration should not be understood as permission to supply all medicines online.

— Temporary closure for more than 60 days requires authorisation; temporary closure may be authorised for up to one year while retaining the operating authorisation, with a maximum continuous closure of three years.

A WDA is required for wholesale dealing in medicines. FAMHP identifies Articles 90 to 99 of the Royal Decree of 2006 as setting out the conditions and application/amendment procedures for wholesale authorisation; when applying for a new WDA, an amendment or withdrawal, the complete, separately prepared attachments must be sent to the designated email address in accordance with the agency’s procedure, and the organisation’s registration in EMA’s OMS must be checked before applying.

GDP applies to WDA holders and also to holders of a manufacturing authorisation who conduct distribution activities, including storage. GDP is an operational quality-system requirement and cannot be replaced by CBE registration or a single product marketing authorisation; imports from third countries still require the relevant manufacturing/import authorisation.

— The application documents should correspond to the actual authorisation holder, business premises and proposed authorised scope; FAMHP requires attachments to be named and submitted separately.

— FAMHP’s page does not publish a standard qualification, nationality, minimum capital, warehouse-area, standard processing-time or licence-expiry requirement applicable to all WDAs; these must be confirmed with FAMHP in light of the scope of the application.

— WDAs and MIAs can be searched in EudraGMDP; a public search reflects only the information recorded and is not pre-approval of a new project.

An MIA is required to manufacture medicines or intermediate products in Belgium, even if they are intended solely for export; all or part of the manufacturing, dividing, packaging or presentation process is within scope. Importing medicines from a third country also requires authorisation. For a new MIA, an amendment or withdrawal, FAMHP requires complete documentation to be submitted using the published forms and the annexes applicable to the authorisation scope.

GMP comprises the principles and guidelines that must be followed when manufacturing medicines and is also the legal basis for inspections conducted by the competent authority. FAMHP explains that medicines authorised for supply to the European market may be handled only by authorised manufacturers/importers that undergo regular inspections and implement quality risk management; in Belgium, inspections are carried out by the Industrial Division of FAMHP’s Inspectorate General.

— An MIA does not mean that a product is authorised for sale in Belgium; the product must still have a valid marketing authorisation, registration, parallel import authorisation or applicable temporary-use authorisation.

— FAMHP recognition of a QPHum must follow Article 84 of the Royal Decree and be supported by a separate application dossier; foreign university qualifications must first be recognised by the competent authority.

— If a manufacturer distributes or stores medicines itself, the distribution activities must also comply with GDP.

Business authorisations and individual professional qualifications are separate. Pharmacy registration includes matters concerning the managing pharmacist; FAMHP also explains that medicines are sold in licensed pharmacies and that dispensing and preparation within a pharmacy are the responsibility of a pharmacist. Healthcare professionals with foreign diplomas who wish to practise permanently in Belgium must first apply to the relevant language community for recognition of EEA/Swiss diplomas; once recognised, the federal professional visa process begins.

Foreign practitioners must also submit documents concerning good character/professional conduct and demonstrate language proficiency; FAMHP lists the pharmacist qualification at master’s level and the language requirement as CEFR C1 (written expression B2). Non-EEA/Swiss diplomas are also subject to the community’s diploma-equivalence procedure. Recognition of a manufacturing QPHum is handled by FAMHP under a separate Article 84 procedure.

— A managing pharmacist, an individual’s professional recognition/visa, and a business’s MIA/WDA/pharmacy establishment authorisation must not be treated as interchangeable.

— Published QPHum application requirements: university diploma, recognition of the diploma where applicable, proof of internship, identity document and application form.

— The materials reviewed do not support a uniform requirement for a “pharmacist coverage ratio during business hours” or for all company roles to require the same qualification.

The location of a public pharmacy is an important part of its establishment authorisation and registration. Where a relocation falls outside the immediate vicinity or is accompanied by closure, the FAMHP page specifies a protected zone of 1.5 kilometres around the new location for two years; for mergers authorised under the 2022 decree, the protected zone is 500, 1,000 or 1,500 metres, depending on the municipality’s population. These are specific rules for public pharmacies, not a general nationwide area requirement for wholesale warehouses or manufacturing premises.

MIA/WDA documents identify the business premises, and storage is covered by GDP; manufacturing/import activities are subject to GMP and regular inspections. Authorisations for controlled-substance activities are more specifically issued for one particular activity at one particular location. The official sources reviewed do not state a uniform minimum area for an ordinary pharmacy, WDA warehouse or MIA manufacturing premises.

— Pharmacy: verify the location, relocation, merger and registration matters in advance.

— Wholesale: manage distribution and storage locations in accordance with GDP.

— Manufacturing: manage the site and processes in accordance with GMP and the authorisation scope; controlled substances are subject to a separate location-specific authorisation.

First establish and maintain accurate business and business-unit details in the CBE; for a sole proprietor, CBE registration is the first official step before starting business. Before applying for an MIA/WDA, also verify that the organisation is registered in EMA’s OMS. FAMHP requires applications for a new MIA or WDA, amendments or withdrawals, together with all required attachments, to be submitted as separate files in accordance with its published requirements.

Public pharmacies submit forms under the establishment authorisation procedure, which involves admissibility review, publication, comments/objections, an inspector’s opinion, a decision and registration; registration matters can now be reported through FAMHP’s online application. Applicants should prepare separate dossiers for personal qualifications, premises, business scope, quality systems, product status and controlled-substance status.

— Business level: CBE enterprise number and applicable business-unit details.

— Pharmacy level: establishment/relocation/merger/closure authorisation and register details.

— Wholesale/manufacturing level: FAMHP forms, authorised scope, separately named attachments and applicable GDP/GMP documentation.

— Product/personnel/controlled-substance level: prepare the relevant authorisations, recognition or batch-specific documents separately.

FAMHP indicates that the full procedure for a public pharmacy establishment authorisation takes approximately four to six months under the 2022 decree; this estimate applies only to that establishment procedure and must not be extended to pharmacy registration, WDA, MIA, product marketing authorisation or controlled-substance projects as a uniform overall timeline. Relocations, mergers, closures and registration amendments are subject to fees, but FAMHP requires applicants to check the current fee schedule.

The MIA/WDA service page explains that manufacturing authorisation fees are included in the annual fee or in supplementary inspection costs outside the annual fee; proof of payment is not required with the application. However, it does not publish a generally applicable fixed total price, statutory expiry period or approval timeline. A controlled-substance activity authorisation, by contrast, is expressly valid for three years from issue, and an application for renewal must be made no later than three months before expiry.

— Pharmacy: confirm fees using the FAMHP fee page and case-specific procedure in force on the date of verification.

— MIA/WDA: confirm the fees for the current year, inspection costs, validity and project timeline with FAMHP.

— Controlled-substance activity authorisation: the three-year validity and renewal application deadline of three months before expiry apply only to this separate authorisation.

WDA holders and holders of manufacturing authorisations who engage in distribution or storage must continuously comply with GDP. Manufacturers/importers must follow GMP, undergo periodic inspections by the competent authority, and implement quality risk management. The scope, business premises and activities authorised under an MIA/WDA must correspond to the actual situation; compliance is required on an ongoing basis, not only when the document is obtained.

Ongoing operation and maintenance of a public pharmacy involve continuing registration and management of closures: reopening, closure, operator, managing pharmacist and website are all registration matters; temporary closure exceeding 60 days requires authorisation. Marketing authorisation holders or parallel distributors must also report marketing, permanent discontinuation or temporary interruption of supply to FAMHP through PharmaStatus. This product-level obligation should not be misrepresented as the same obligation for all pharmacies or WDAs.

— GDP: wholesale and, where applicable, distribution/storage by manufacturers.

— GMP: manufacture/import, quality risk management and periodic FAMHP inspections.

— Pharmacies: maintain registration information, website and closure status in accordance with FAMHP procedures.

— Products: marketing/supply interruption reports are separately submitted by the marketing authorisation holder or parallel distributor.

Transfers of public pharmacy operating authorisations, changes of operator or managing pharmacist, acquisitions, relocations, mergers, closures and website status must all be registered with FAMHP. FAMHP's online registration notice specifically states that openings, mergers, transfers, temporary/permanent closures, and changes including pharmacy acquisitions must be reported; this does not support treating a pharmacy authorisation as an asset that automatically transfers with a transaction.

The public application pathways for MIAs/WDAs cover new applications, amendments and withdrawals. Before implementing a proposed change to the licence-holding entity, address, premises, activity or scope, confirm the requirements using FAMHP forms and case-specific guidance. Changes to information concerning a controlled-substance activity permit must be reported within 15 days; as the permit is issued for a single site and a single legal entity company number, a change of site or legal entity requires a new application.

— Pre-transaction due diligence: verify the authorisation/registration holder, operator, CBE enterprise number, premises, managing pharmacist and actual activities.

— Pharmacies: report matters such as authorisation transfers or acquisitions in accordance with the registration procedure.

— MIA/WDA: use FAMHP's amendment/withdrawal procedures; do not assume that changes in shareholding are exempt from notification.

— Controlled substances: the 15-day change-reporting rule and the requirement for a “new site/new legal entity” application apply only to that activity permit.

The FAMHP medicines database lists human and veterinary medicines with a valid marketing authorisation, registration, parallel import authorisation or temporary-use authorisation in Belgium. Product authorisation/registration is distinct from an entity's MIA, WDA or pharmacy establishment authorisation. FAMHP also explains that authorised medicines are assessed by the competent authority for quality, safety and efficacy before being marketed; traditional herbal medicines and certain homeopathic medicines may follow a separate “registration” pathway.

Medicines from EEA countries with the same or a similar reference medicine in Belgium may qualify for a parallel import authorisation; amendments are generally submitted separately, and may be combined only in specified cases involving a change to the holder's name/address or an increase/decrease in legal entities. Imports from third countries require an MIA. In the event of a shortage, FAMHP may, under limited conditions, authorise wholesalers to distribute medicines imported from the EEA but not authorised in Belgium; pharmacists may also import in certain circumstances, subject to conditions such as a doctor's declaration and the absence of an equivalent medicine. None of these is a general import right.

Narcotic drugs and psychotropic substances are separately regulated under the Royal Decree of 2017. Activities including manufacture, sale, supply, transport, import and export require an activity permit for a specific site in advance; each consignment of imports or exports also requires the corresponding prior authorisation, and the applicant must hold a valid activity permit or end-user permit.

— Product marketing: check the FAMHP medicines database and the applicable MA/registration/parallel import/temporary-use status.

— Parallel import: this is a product-level parallel import authorisation; it is not equivalent to a WDA, MIA or pharmacy authorisation.

— Imports from third countries: MIA; controlled substances: activity permit plus authorisation for each import/export consignment, potentially in addition to GDP/GMP.

— Special shortage pathway: use only under the conditions set out by FAMHP; it is not a routine procurement option.