Summaries of Product Characteristics and leaflets now on line

The Vice-Prime Minister and Minister of Public Health, Laurette Onkelinx, announced on Monday 11/01/2010 at a press conference that the FAMHP now makes available on its website, for health (human or animal) professionals and for patients, the Summaries of Product Characteristics (SPC) and the package leaflets of medicinal products for human or veterinary use that are authorized and marketed in Belgium.

At the time of the marketing authorisation (MA) of medicines, often called the registration, the FAMHP or the European Commission approves as the competent authorities, the Summaries of Product Characteristics (SPC) and the leaflets of those medicines.
The SPC, which are primarily designed for healthcare professionals or veterinary surgeons, and the leaflets constitute the information and the basic reference for appropriate and safe prescribing, delivery and use of medicines for human or veterinary use.

It is therefore essential that these documents are readily accessible in their full version and updated to all those who need it (healthcare professionals and patients).That is why FAMHP now offers free access to these documents on its websitevia the link "Summaries of Product Characteristics and leaflets" in accordance with the legal obligation.

The publication of the SPC and the package leaflets is related to the medicines for human or veterinary use authorized and marketed in Belgium. The SPC are available in French and Dutch; the package leaflets are in the three national languages (the German version of the package leaflets of veterinary medicines is not yet available but will be soon).

These SPC and packages leaflets will be updated regularly, when changes are made and when new medicines are marketed.

The documents can be printed easily and much attention has been paid to their presentation. The package leaflet published on the website of FAMHP, viewed on line or printed, offers better readability than that attached to the packaging of the medicine. It is easier to read for some patients but also responds to a real genuine will that everyone, and especially those who have sight problems, can benefit from the necessary information for the proper and safe use of the medicines they need. In case of loss, the patient can also easily find a complete and updated version of the package leaflet of the medicines inn his / her medicines cabinet at home. The work of healthcare professionals should be easier because they can find in one place all the SPCs of medicines approved and marketed in Belgium.

To make this valuable research tool, the FAMHP relied on the close collaboration of pharmaceutical companies to whom we extend our sincere thanks.

In practice ...
The heading "Summaries of Product Characteristics (SPC) and leaflets" on the right hand side of the home page of the website directs you to the page where you can search these documents. Just choose the tab "Human Use" or "Veterinary use" depending on the subject being researched, read the short explanatory note and then search by medicine name.

Note that normally a SPC and / or package leaflet concern(s) several different presentations of the medicine. That is why sometimes for one name of medicine, there is also a different number of SPC and leaflets.

Press contact and actions for external communications

Communication Division


Ann EECKHOUT, spokesperson and Dutch contact, responsible for the Communication Division
tél.              0032 2 524 80 12
mobile           0032 495 23 71 69

Bénédicte SIMON, French contact
tél.              0032 2 524 84 16


Last updated on 11/01/2010