The registered pharmacist-in-charge manages a pharmacy open to the public . He or she can be supported or replaced by one or more other pharmacists and can also call on assistant pharmacists.
Legal obligations and controls
The legislation for pharmacies open to the public is very complex. Pharmacists must respect legal requirements concerning among other things :
• storing and dispensing medicines;
• narcotic drugs and psychotropic substances;
• producing magistral and officinal preparations;
• maintaining registers and documentation about his or her actions.
Every pharmacist is responsible for the quality of the medicines and health products he or she dispenses.
As far as possible, the pharmacist must ensure that those responsible for the animals use the medicines correctly by :
• providing information about possible side effects;
• giving advice on dosage (posology) of medicines;
• investigating interactions between medicines in animals taking multiple medicines simultaneously.
The FAMHP’s pharmacist-inspectors control whether pharmacists comply with the regulations. If not, they may impose sanctions.
Distribution of pharmacies and the register
Opening, transferring, merging, closing ... a pharmacy requires a licence. Certain changes (additional cadastral plot, pharmacist-in-charge, licence holder, etc.) must be reported to the register. In some cases, an inspection is carried out (transfer, additional cadastral plot...).
Opening or closing a pharmacy open to the public
To open a public pharmacy you need a licence, granted by the minister of public health. Because there is currently a moratorium in place, you cannot apply for a new license to open. The list of licensed pharmacies can be found on the FAMHP website.
Does your pharmacy open to the public close for more than sixty days? Request this using the form for the temporary closure of a pharmacy (available in Dutch or French).
Moving a pharmacy open to the public to another location or merging two pharmacies
In order to move an existing public pharmacy to another address (a so-called transfer), you'll need a license, granted by the minister of public health. A license is also required for a merger of two pharmacies. You can request this license using the request form (available in Dutch or French).
In the list of recent transfers you can see whether a location falls in the exclusion zone of 1.5 km around a new establishment according to the Business Establishment Decree for public pharmacies. You can also check if there is currently a procedure running at a certain location.
- The list contains both the original locations as well as intended new locations.
- The columns “Result MB” and “Date MB” indicate whether and when the minister of public health has made a decision and whether it is positive or negative.
- The "Procedure" column indicates the type of transfer.
- FUSI: merger (according to the old legislation);
- TR: transfer in the immediate vicinity of the original location within a radius of 100 metres (according to the old legislation);
- TRGR: transfer according to article 1, § 5bis, 1° and 3° of the old legislation;
- FUSI2022: merger under the conditions of the Royal Decree of 16 January 2022;
- TR2022: transfer in the immediate vicinity of the original location within a radius of 100 metres or within the 25% zone as defined in appendix 1 of the Royal Decree of 16 January 2022;
- TRGR2022: transfer according to article 10, § 1, 1° or 2° of the Royal Decree of 16 January 2022;
- FUSITR2022: transfer according to article 10, § 1, 1° or 4° of the Royal Decree of 16 January 2022.
- You can therefore also check in the list which mergers have taken place. For mergers authorised according to article 3, § 2 of the Business Establishment Decree for public pharmacies (the old legislation), no one may open or transfer a public pharmacy within a radius of 1.5 km around a merged public pharmacy for ten years. Moving an existing public pharmacy into that zone is permitted if the transfer takes place due to force majeure or within a radius of 100 metres. For mergers authorised by the Royal Decree of 16 January 2022, there is similar protection, but the perimeter is variable (500, 1,000 or 1,500 metres) according to the population of the municipality (> 30,000 inhabitants, ≤ 30,000 inhabitants and ≥ 7,500 inhabitants, < 7,500 inhabitants.
Changing the registration of a pharmacy open to the public
Changing the registration of your public pharmacy to, for example, register another pharmacist-in-charge, an additional cadastral plot or license holder, must be notified to the FAMHP using this notification form (available in Dutch or French).
Determining the geographical location of pharmacies
The FAMHP has added the geographical coordinates of all pharmacies open to the public to the list of licensed pharmacies in X,Y format. Pharmacists can check the coordinates using websites such as TopoMapViewer or CadGIS.
Should there nevertheless be an error, license holders can request a correction by means of a surveyor's certificate. Especially when a pharmacy is located on a relatively large cadastral plot (hospital, shopping centre, station, etc.), there is a chance that the coordinates do not exactly match the pharmacy. Pharmacies that have a authorisation to transfer but have not yet physically transferred do not need to request a correction as this will be adjusted upon registration. Pharmacies with a transfer authorisation that have already been physically transferred but have not yet registered the transfer are invited to do so as soon as possible.
Corrections can be requested up to 09.05.2022 by
• e-mail : registration_pharmacy@fagg-afmps.be
• letter : Federal Agency for Medicines and Health Products
DG Inspection - Authorisations Division - Register of Pharmacies
Avenue Galileelaan 5/03
1210 BRUSSELS
Please use an acknowledgement of receipt or registered mail.
Contact
pharmacy@fagg-afmps.be