Establishment of pharmacies
The opening, relocation, merger or closure of a pharmacy requires authorisation to establish a pharmacy.
Opening a pharmacy open to the public
To open a pharmacy open to the public, authorisation must be granted by the Minister responsible for Public Health. However, due to a moratorium, it is not possible to apply for a new opening authorisation before 2029 (article 44 of the Royal Decree of 16 January 2022).
Relocation or merger of public pharmacies
In order to relocate an existing public pharmacy to a different address (within or beyond its immediate vicinity, a temporary relocation or with a view to closure), authorisation must be obtained from the establishment official or the Minister responsible for Public Health.
Authorisation is also required to merge two pharmacies. Applications must be submitted using the request form (available in Dutch or French ). Only the holder of the authorisation can apply. The application must be accompanied by a sworn surveyor's report.
• List of recent relocations
In the list of recent relocations, you can check whether a procedure is currently in progress at a specific location. You can also verify whether a proposed site falls within the protection zone of a relocation or merger.
In the case of relocations beyond the immediate vicinity and relocations with a closure, a protection zone with a radius of 1.5 kilometres around the new site applies for a period of two years.
For mergers previously authorised under Article 3 § 2 of the Royal Decree on the opening, relocation and merger of public pharmacies (former legislation), no one may open or relocate a public pharmacy within a radius of 1.5 kilometres of a merged public pharmacy for ten years.
For mergers authorised by the Royal Decree of 16 January 2022, a similar restriction applies, but the protection zone varies (500, 1 000 or 1 500 metres) depending on the municipality's population (more than 30 000 inhabitants, between 7 500 and 30 000 inhabitants and fewer than 7 500 inhabitants).
It is possible to relocate an existing public pharmacy in this area if the relocation is within the immediate vicinity.
In the list of recent relocations, the ‘Procedure’ column indicates the type of application or authorisation:
• FUSI: merger (under previous legislation);
• TR: relocation within the immediate vicinity of the original site, within a radius of 100 metres (under the previous legislation);
• TRGR: relocation in accordance with Article 1, § 5bis, 1° and 3° of the previous legislation;
• TRGR22: relocation based on demographic criteria (Article 10, § 1, 1° or 2° of the Royal Decree of 16 January 2022);
• TR22: relocation within the immediate vicinity of the original site (Article 10, §1, 3° of the Royal Decree of 16 January 2022). The condition for a relocation within the immediate vicinity is that the new site must be located within a 100-metre radius of the original location, or within the 25 % zone, as defined in Appendix 1 of the Royal Decree of 16 January 2022 ;
• TYTR22: temporary relocation within the immediate vicinity. This may be authorised for a maximum period of three years (Article 11 of the Royal Decree of 16 January 2022);
• SLTR22: relocation + closure (Article 10, § 1, 4° of the Royal Decree of 16 January 2022);
• FUSI22: merger of two pharmacies (Article 9 of the Royal Decree of 16 January 2022);
• TYSL22: temporary closure (Royal Decree of 16 January 2022);
• DEFS22: permanent closure (Royal Decree of 16 January 2022).
Temporary or permanent closure of a pharmacy open to the public
If a pharmacy open to the public is to be closed temporarily for more than sixty days, authorisation is required for the entire duration of the closure (article 29 of the Royal Decree of 16 January 2022). Temporary closure with continued authorisation to operate may be granted for a period of up to one year. If the temporary closure is to be extended beyond one year, a compelling justification must be provided at the time of application.
A pharmacy open to the public may remain closed for a maximum of three consecutive years, while retaining its operating authorisation.
It is also necessary to apply for authorisation for the permanent closure of a pharmacy.
Applications for either temporary or permanent closure can be submitted using the application form (available in Dutch or French ).
Procedure
The procedure as set out in the Royal Decree of 16 January 2022 is summarised below.
1. Application.
2. Admissibility check and publication on the FAMHP website in the list of recent relocations.
3. Any comments or objections.
4. Inspector's opinion.
5. Decision by the establishment official or minister, followed by publication.
6. Registration of the authorisation to establish a pharmacy submitted to the pharmacy registry (if authorisation is granted).
In accordance with the deadlines set out in the Royal Decree of 16 January 2022, the entire procedure, from application to granting or refusal of an authorisation to establish a pharmacy, takes between four and six months.
Once an authorisation to establish a pharmacy has been granted, it must be registered with the pharmacy registry in a timely manner. This can now be done more quickly and efficiently using our digital application. The authorisation expires upon first use, or at the latest two years after its publication.
Fees
Applications for relocation, merger or closure are subject to a fee. Current rates can be found on our website.
Contact
establishment_pharmacy@fagg-afmps.be
Pharmacy registry
List of authorised pharmacies
The list of authorised pharmacies is available on the FAMHP website. The FAMHP has added the geographical coordinates (in X,Y format) of all pharmacies open to the public to the list of accredited pharmacies. Pharmacists can check these coordinates using websites such as TopoMapViewer or CadGIS.
Changing the registration of a public pharmacy
The pharmacist-in-charge and/or the holder of an authorisation for a pharmacy open to the public can make the following changes in the pharmacy registry:
• (re)opening or closing of the pharmacy;
• merger or relocation of the pharmacy;
• transfer of the operating authorisation;
• change of address of the authorisation holder (if a natural person);
• change of operator;
• change of the pharmacy's trading name or correction of its address, without changing its actual location (e.g. in the event of a merger of municipalities);
• request to add or remove an adjacent or non-adjacent cadastral parcel;
• change of pharmacist-in-charge or person responsible for registration;
• launch or deactivation of a website selling over-the-counter medicines;
• delegation of magistral preparations;
• the existence, application or discontinuation of automated individual medication preparation (IMP);
• updating contact details.
The authorisation to open or relocate a pharmacy must be registered at least 60 days before the planned opening at the intended location.
You can now submit your registration request more quickly and efficiently using our digital application. The previous declaration form (available in Dutch or French ) will remain available during a transitional period.
Depending on your registration request, a pharmacy inspection may be scheduled in certain situations.
Payment
Requests to change the registration are subject to a fee. Current rates can be found on our website.