The web portal of the FAMHP

The web portal of the FAMHP has been developed in the framework of a project to reform the control policy of the FAMHP.

Objectives

  • Rationalisation of the market surveillance by the competent services of the FAMHP.
  • Optimising the planning and execution of inspections based on risk analysis.
  • Reinforcing administrative simplification (observing the "only once"-principle, digitalisation of administrative processes).
  • Ensuring transparency and synergies with all stakeholders.

At the moment, the web portal can be used by actors in the sector of medical devices and registered pharmacists-in-charge of pharmacies open to the public. They are responsible for the conformity of the information provided and for updating and completing their data when necessary. The FAMHP uses the information received via the web portal to optimise the efficiency of controls.

Medical devices

  • Actors in the medical devices sector can register here. Registering on the portal allows you to :
    • Register your activities (distributor, manufacturer, authorised representative,...)
    • Apply for certificates of free sale in electronic format,
    • Notify the distribution of implants, of long-term invasive devices and of mobile applications,
    • Notify the manufacture of custom-made devices,
    • Notify devices manufactured and used only within health institutions,
    • Notify reprocessing of single-use devices and the use of reprocessed devices within health institutions,
    • Fill in an auto control form (risk analysis) and simplify the communication of inspection reports, corrective action plans and other useful documents between the actor and the inspection services
    • Submit annually the declaration of turnover

Pharmacies open to the public

  • Registered pharmacists-in-charge of a pharmacy open to the public are able to:
    • Receive and consult the reports of the inspections and sample takings carried out in their pharmacy;
    • Complete the corrective and preventive action plan (CAPA) in the event of non-conformities found during an inspection or in the case of non-conforming sample takings;
    • Attach documents necessary for the follow-up of the controls;
    • Consult at any time easily the documents mentioned above;
    • Change the e-mail address of the pharmacy when necessary;
    • At a later stage, complete the risk form of the pharmacy.