16 documenten
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Notitie 'Uitbreiding medische indicatie' toegelaten medicijnen (revisie) 1710231779 Notitie 'Uitbreiding medische indicatie' toegelaten medicijnen (revisie)PDF | 219,56 kB
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Good Practice on the assessment of GMO-related aspects in the context of clinical trials with human cells genetically modified by means of viral vectors v5 1694786673 Good Practice on the assessment of GMO-related aspects in the context of clinical trials with human cells genetically modified by means of viral vectors v5PDF | 471,66 kB
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Common Application form for clinical research with human cells genetically modified by means of viral vectors v5 1694786544 Common Application form for clinical research with human cells genetically modified by means of viral vectors v5DOCX | 30,30 kB
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Voorbeelden meldingscategorieën Rggo art35c 1673515424 Voorbeelden meldingscategorieën Rggo art35cPDF | 110,63 kB
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Wijziging Regeling ggo 2013 tav meldingen klinische studies 1673515281 Wijziging Regeling ggo 2013 tav meldingen klinische studiesPDF | 1,47 MB
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Gestandaardiseerde MRB VOV gm cellen AAV (art39d) 1673464411 Gestandaardiseerde MRB VOV gm cellen AAV (art39d)PDF | 598,01 kB
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10-2021 Guidance document VOV art 39d gm-cells AAV 1673464163 10-2021 Guidance document VOV art 39d gm-cells AAVDOCX | 34,92 kB
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application form VOV gm cells_art39d_2022-12 v1.1_EN 1673463783 application form VOV gm cells_art39d_2022-12 v1.1_ENDOCX | 44,78 kB