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Application under the scope of the Belgian regulation on deliberate release of GMO's
(Author: M. Goossens - Last revised:
June 6, 2012
)
The text of this regulation is available from this Web site,
in Dutch and
in French.
The application
is submitted to the Competent authority which forward a copy to the SBB; the
dossier is reviewed by the Belgian Biosafety Council which transmits its advice
to the competent
authority for final decision. This decision is delivered after
maximum 90 days.
Application content
Conform Art.13 the Royal Decree of 21 February 2005 the biosafety dossier is mainly constituted by:
• A technical dossier conform to Annex III of the Royal
Decree of 21 February 2005 including: the clinical protocol(s), the EUDRACT nr., and when available: the investigator's brochure, the GMP/quality
data, the information for the patient, the study staff instructions;
• the Summary Notification Information Format (SNIF).
The SNIF needs to be completed in english (a template for organisms other than
plants is available on the web site of Joint Research Center (JRC) of the European
Commission (link)).
This form is forwarded to the European Commission and to
the other Member States for potential comments and is published on the web site
of Joint Research Center (JRC) of the European Commission (link) ;
• an environmental risk assessment conform to Annex II of the Royal Decree of 21 February 2005 ;
• a proposal for public information in dutch and in french (guidelines for public information are available in English as PDF file)
• an electronic version of the complete dossier is requested (PDF files + word version of the SNIF).
Control sample
The Royal Decree of 21 February 2005 requires that the notification contains a declaration of the notifier where he agrees to deliver to the SBB a control sample and the related scientific documentation the latest 15 days after the start of the trial.This sample is asked to make the detection and identification of the recombinant virus or micro-organism possible in case of inspection or accidental release.
The nature and quantity of the sample will depend of the detection method proposed by the notifier in the application. But the notifier should comply to the requirements detailed in the following document : Guideline for Part B PCR detection method (available as PDF file).
This material and related information is for the sole purpose of the execution of the SBB mandate as provided by the Royal Decree. Material and info are handled as strictly confidential. The intellectual property rights remains with the notifier.
An application under the scope of the Belgian regulation on deliberate release of GMO's do not exempt to apply a dossier under the scope of the Belgian regional regulations on contained use of GMO's and/or pathogen organisms. It will cover all the related contained use activities (storage and handling of medication, biological samples, hospital rooms, waste disposal...). See Procedural aspects for the authorisation of gene therapy clinical trials in Belgium.
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