Beslissing tot onderwerping van de uitvoer van geneesmiddelen die budesonide vernevelsuspensie bevatten, bestemd voor de Belgische markt, aan een voorafgaande toelating, de 20 février 2023
Artikel M.
BESLUIT de uitvoer van geneesmiddelen die budesonide vernevelsuspensie bevatten bestemd voor de Belgische markt aan een voorafgaande toelating te onderwerpen tot en met 15 juli 2023.De betrokken geneesmiddelen zijn de volgende:1° Budesonide EG 0,25 mg/ml (20 x 2 ml en 60 x 2 ml) en Budesonide EG 0,5 mg/ml (20 x 2 ml en 60 x2 ml);2° Budesonide Sandoz 0,25 mg/ml (20 x 2 ml en 60 x 2 ml) en Budesonide Sandoz 0,5 mg/ml (20 x 2 ml en 60 x2 ml);3° Budesonide Teva 0,25 mg/ml (20 x 2 ml en 60 x 2 ml) en Budesonide Teva 0,5 mg/ml (20 x 2 ml en 60 x2 ml);4° Pulmicort 0,25 mg/ml 20 x 2 ml en Pulmicort 0,5 mg/ml 20 x 2 ml;5° Pulmicort (PI-pharma) 0,25 mg/ml 20 x 2 ml en Pulmicort (PI-pharma) 0,5 mg/ml 20 x 2 ml.Deze beslissing treedt in werking op de dag van publicatie in het Belgisch Staatsblad.
Handtekening
Brussel, 16 februari 2023.
F. VANDENBROUCKE
Aanhef
De Minister van Volksgezondheid,
Gelet op de wet van 25 maart 1964 op de geneesmiddelen voor menselijk gebruik, artikel 12septies, tweede lid;
Gelet op het koninklijk besluit tot uitvoering van artikel 12septies, tweede lid, van de wet van 25 maart 1964 op de geneesmiddelen, artikel 4, § 1, § 2, eerste lid en § 3, eerste lid;
Overwegende dat de onbeschikbaarheid, in de zin van artikel 2, 29), van het koninklijk besluit van 14 december 2006 betreffende geneesmiddelen voor menselijk en diergeneeskundig gebruik, van geneesmiddelen die budesonide vernevelsuspensie bevatten aan het FAGG bekend werd gemaakt;
Overwegende dat voor sommige verpakkingen van geneesmiddelen die budesonide vernevelsuspensie bevatten de onbeschikbaarheid zou aanhouden tot 15 juli 2023 en er pas op dat moment zekerheid bestaat over een voldoende aanbod op de Belgische markt;
Overwegende dat budesonide...
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