Koninklijk besluit houdende uitsluiting van geneesmiddelen uit de procedure van goedkeuring van prijzen in bijzondere omstandigheden of situaties van overmacht, de 19 juillet 2021
Artikel 1. In het koninklijk besluit van 10 april 2014 tot vaststelling van de ontvankelijkheidsvoorwaarden, de termijnen en de praktische modaliteiten voor aanvragen tot prijsvaststelling, aanvragen tot prijsverhoging, prijskennisgevingen en (prijs)meldingen van geneesmiddelen, met geneesmiddelen gelijkgestelde voorwerpen, apparaten en substanties, en grondstoffen, als bedoeld in boek V van het Wetboek van economisch recht, laatst gewijzigd bij het koninklijk besluit van 2 september 2018, wordt een hoofdstuk 8/1 ingevoegd dat artikel 27/1 bevat, luidende:
"Hoofdstuk 8/1. Uitsluiting in bijzondere omstandigheden of situaties van overmacht
Art. 27/1. In afwijking van hetgeen bepaald is in hoofdstuk 2 en in artikel 15, zijn de geneesmiddelen die in aanmerking komen voor een tijdelijke wijziging van de lijst van vergoedbare farmaceutische specialiteiten overeenkomstig het artikel 2 van het koninklijk besluit van 26 januari 2021 tot vaststelling van de procedures, termijnen en voorwaarden inzake de tegemoetkoming van de verplichte verzekering voor geneeskundige verzorging en uitkeringen in de kosten van farmaceutische specialiteiten in buitengewone omstandigheden of overmachtsituaties, uitgesloten uit de werkingssfeer van boek V, titel 2, hoofdstuk 2, van het Wetboek van economisch recht.
Op het moment van zijn beslissing stelt de minister bevoegd voor Sociale Zaken of zijn vertegenwoordiger de Prijzendienst in kennis van het voorstel bedoeld in artikel 2, tweede lid, van het voornoemde koninklijk besluit van 26 januari 2021. Hij vermeldt hierbij de farmaceutische specialiteiten waarop dit voorstel betrekking heeft.
De bedoelde uitsluiting geldt enkel met het oog op de in het eerste lid bedoelde tijdelijke wijziging van de lijst van vergoedbare farmaceutische specialiteiten. Zij vervalt op de datum waarop de tijdelijke inschrijving in overeenstemming met artikel 2, vierde lid, van het voornoemde koninklijk besluit van 26 januari 2021, vervalt.".
Art. 2. De minister bevoegd voor Economie en de...
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