20 APRIL 2004. - Ministerieel besluit houdende schorsing van de aflevering van geneesmiddelen die tolcapone bevatten
De Minister van Sociale Zaken en Volksgezondheid,
Gelet op de wet van 25 maart 1964 op de geneesmiddelen, inzonderheid op artikel 8, gewijzigd bij de wet van 20 oktober 1998;
Gelet op de beschikking van de Commissie van 14 januari 2004 tot schorsing van de vergunning voor het in de handel brengen van het geneesmiddel voor menselijk gebruik « Tasmar-Tolcapone »;
Gelet op het ministerieel besluit van 10 april 2002 houdende schorsing van de aflevering van geneesmiddelen die tolcapone bevatten;
Gelet op het advies van de Geneesmiddelencommissie van 12 december 2003;
Gelet op het advies nr. 36.774/3 van de Raad van State, gegeven op 22 maart 2004, in toepassing van artikel 84 § 1, 2° van de gecoördineerde wetten op de Raad van State;
Gelet op het spoedeisend karakter, gemotiveerd door het feit dat :
-het ministerieel besluit van 10 april 2002 houdende schorsing van de aflevering van geneesmiddelen die tolcapone bevatten, vervalt op 18 april 2004;
- er redenen zijn om aan te nemen dat de werking van tolcapone schadelijk kan zijn, en meer bepaald ernstige leverfunctiestoornissen kan veroorzaken;
- de...
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