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Regulatory framework for clinical trials with GMO-veterinary vaccines in Belgium
(Authors: M. Sneyers and M. Goossens - Last revised:
May 5, 2010
)
A clinical trial in the field with a veterinary vaccine consisting of or containing a GMO falls under the scope of the the Belgian regulation on the deliberate release of GMO's which implements Directive 2001/18/EC.
Procedural aspects
Tthe application is submitted to the Federal Agency for Medicines and Health product and is also sent to
the SBB; the dossier is reviewed by the Belgian
Biosafety Advisory Council which transmits its advice to the competent
authority for final decision. This decision is delivered after maximum 90
days.
Application content
The biosafety dossier is mainly constituted by:
• A technical dossier conform to Royal Decree of 21 February 2005 and including: an environmental risk assessment conform to Annex II of the Royal Decree of 21 February 2005, the clinical protocol(s) and the investigator's brochure, the GMP/quality data
• 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)). The
SNIF is also required in the language(s) of the region(s) involved by the trial
(templates available as PDF file in
Dutch - in French). 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 the Joint Research Center
(JRC) of the European Commission (link)
• a proposal for public information in Dutch, in French
and also in English (guidelines for public information are available in English
as PDF
file)
• a copy of the approval of the Ethics Committee.
• an electronic version of the complete dossier is requested
by the Division of Biosafety and Biotechnology (SBB) (PDF files + word version
of the English version of the SNIF).
The field trials approved or submitted for approval in Belgium are listed in a database:
For
the procedures concerning trials conducted inside contained animal houses,
consult the pages dealing with the contained
use of GMOs and pathogens.
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