NEW

Recent additions and changes to this website

Ajouts et modifications récents à ce site

Nieuwigheden en recente wijzigingen op deze website

 

19/08/2020 - Update: Biosafety guidelines for the diagnostic and research activities involving the SARS-CoV-2, in French and Dutch

30/07/2020 - Update: Poliomyelitis eradication and poliovirus laboratory containment - GAPIII (Global Action Plan III)

22/07/2020 - Addition: Clinical trials with investigational medicinal products for COVID-19 containing or consisting of GMOs: Temporary derogation from the GMO legislation (in French, Dutch and English)

18/06/2020 - Update: Kleine aanpassing in de kennisgevingsprocedure voor activiteiten van “ingeperkt gebruik” in Vlaanderen. Gezien de wijziging van milieuvergunningen van bepaalde duur naar omgevingsvergunningen van onbepaalde duur, zijn we procedureel verplicht volgende wijziging door te voeren. Kennisgevingen zijn enkel nog mogelijk voor het melden van wijzigingen (doelstelling, lokalen, biologisch materiaal, aangewende technieken,…) in reeds toegelaten activiteiten. Nieuwe activiteiten dienen steeds via een toelatingsaanvraag te gebeuren. Indien er een toelating wordt verstrekt, zal deze geldig zijn voor een specifieke periode (te bepalen door de technisch deskundige). In geval van een kennisgeving wordt de geldigheidstermijn van de in het verleden vergunde activiteit (waarop de kennisgeving van de wijziging slaat) overgenomen.

Deze aanpassing is van toepassing vanaf 1/07/2020. Voor de dossiers die vóór 1/07/2020 werden ingediend en positief worden geadviseerd, zal automatisch een schriftelijke toelating met een geldigheidstermijn van 5 of 10 jaar (te bepalen door technisch deskundige) uitgeschreven worden, tenzij de activiteit nog onder een milieuvergunning/omgevingsvergunning van bepaalde duur valt.

18/06/2020 - Update: FAQ W5 (dossierrechten ingeperkt gebruik voor het Vlaams Gewest)

05/06/2020 - Update: Biosafety guidelines for the diagnostic and research activities involving the SARS-CoV-2, in French and Dutch

29/05/2020 - Update: Biosafety guidelines for the diagnostic and research activities involving the SARS-CoV-2, in French and Dutch

07/05/2020 - Update: Biosafety guidelines for the diagnostic and research activities involving the SARS-CoV-2, in French and Dutch

15/04/2020 - Update: Biosafety guidelines for the diagnostic and research activities involving the SARS-CoV-2 (2019-nCoV), in French and Dutch

10/04/2020 - Update: Biosafety guidelines for the diagnostic and research activities involving the SARS-CoV-2 (2019-nCoV), in French and Dutch

25/03/2020 - Update: Biosafety guidelines for the diagnostic and research activities involving the SARS-CoV-2 (2019-nCoV), in French and Dutch

04/03/2020 - Update: Biosafety guidelines for the diagnostic and research activities involving the SARS-CoV-2 (2019-nCoV), in French and Dutch

11/02/2020 - New: Biosafety guidelines for the diagnostic and research activities involving the SARS-CoV-2 (2019-nCoV), in French and Dutch

10/02/2020 - Update: Contained use of GMOs and/or pathogens: Notification procedure in the Flemish Region

09/01/2020 - Updated data: Clinical trials with GMOs: Some figures

07/01/2020 - Update: Notification procedures: Clinical Trials with GMOs for human or veterinary use

24/10/2019 - Updated forms: Contained use of GMOs and/or pathogens: Notification procedure in the Flemish RegionBrussels-Capital Region and Wallonia

27/09/2019 - Update: Contained use of GMOs and/or pathogens: Notification procedure in Wallonia

26/09/2019 - Updated forms: Contained use of GMOs and/or pathogens: Notification procedure in the Flemish RegionBrussels-Capital Region and Wallonia

24/07/2019 - Update: Commercialisation of GMO medicinal products: Some figures

12/06/2019 - UpdateContained use of GMMs: Emergency planning

11/06/2019 - Addition: Documents containing recommendations on storage and internal transport for activities of contained use (only in FR and NL).

11/06/2019 - Update: User request forms for the classification of micro-organisms which don't appear on the lists of pathogenic micro-organisms.

20/05/2019 - Update: Information for notification forms for certain clinical trials in humans in the frame of notifications for contained use activities in the Flemish RegionBrussels-Capital Region and Wallonia

20/05/2019 - Update: Clinical trials with GMOs: Some figures

13/05/2019 - Update: Guidance on the use of GMOs in clinical trials

13/05/2019 - Added event: International course Principles of Biosafety

11/04/2019 - Updated forms: Contained use of GMOs and/or pathogens: Notification procedure in the Flemish RegionBrussels-Capital Region and Wallonia

22/02/2019 - Update: A new request for a clinical trial with a medicinal GMO (notification B/BE/19/BVW2) has been submitted by BioMarin. It is currently evaluated by the Biosafety Advisory Council.

07/11/2018 - Update: Notification procedures for clinical trials with GMOs for human or veterinary use, updated explanations to the procedures and added template documents.

22/10/2018 - Update: Legal status of organisms obtained by targeted genome editing, following the ruling of the European Court of Justice of 25 July 2018.

17/10/2018 - Addition: Translations in English of the containment and protective measures documents for containment levels L1, L2, HR1 and HR2.

04/10/2018 - Addition: Biological incident report form for the notification of a Laboratory Acquired Infection or a biological incident during an activity of contained use

04/10/2018 - UpdateOnline occupational bio-incident notification platform

07/08/2018 - Updated forms: Contained use of GMOs and/or pathogens: Notification procedure in the Flemish RegionBrussels-Capital Region and Wallonia

24/07/2018 - Update: Notification procedures: Clinical Trials with GMOs for human or veterinary use (in particular "Information requested for a ‘deliberate release’ dossier")

07/06/2018 - Addition: Flowchart for decision for the handling of environmental or patient samples in containment (page on the application of the GMO legislation in the case of pathogenic micro-organisms)