Beslissing tot onderwerping van de uitvoer van het geneesmiddel Actosolv bestemd voor de Belgische markt aan een voorafgaande toelating, de 6 décembre 2023
Artikel M. BESLUIT de uitvoer van het geneesmiddel Actosolv 100000 IU inj./inf. opl. (pdr.) i.v./i.arter. en Actosolv 600000 IU inj./inf. opl. (pdr.) i.v./i.arter. bestemd voor de Belgische markt aan een voorafgaande toelating te onderwerpen tot en met 31 augustus 2024.
Deze beslissing treedt in werking op de dag van publicatie in het Belgisch Staatsblad.
Handtekening
Brussel, 6 december 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 van 19 januari 2023 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 ;
Gelet op de mededeling aan de Europese Commissie, op 30 november 2023, met toepassing van de artikels 5, lid 1 en 6, lid 7, van de richtlijn (EU) 2015/1535 van het Europees Parlement en de Raad van 9 september 2015 betreffende een informatieprocedure op het gebied van technische voorschriften en regels betreffende de diensten van de informatiemaatschappij;
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 het geneesmiddel Actosolv aan het FAGG bekend werd gemaakt ;
Overwegende dat de onbeschikbaarheid van het geneesmiddel Actosolv tot 31 augustus 2024 zou aanhouden ;
Overwegende dat het geneesmiddel Actosolv wordt gebruikt voor de behandeling van een uitgebreid en acuut...
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