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Contained
Use of GMOs and pathogens
Notification forms for
the Brussels Region
(Last revised:
May 5, 2010
)
The whole information that has to be given to notify a contained use activity represents the biosafety dossier. In order to facilitate the information and notification procedures and to limit at the minimum the administrative constraints for the notifiers, the Division of Biosafety and Biotechnology (SBB) has, in collaboration with the Brussels Institute for Management of the Environment (IBGE-BIM), developed notification forms and a user guide, on the basis of the requirements of the regional decree but also of the experience gained as regards implementation of this regulation.
Before the
preparation of the biosafety dossier and to any administratve
step, the notifier is invited to consult the Division
of Biosafety and Biotechnology.
Following this consultation, a certificate of consultation will be given to the
notifier by the SBB.
To get the notification forms and the user guide
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Download the documents while clicking on the links below (Word format):
General
overview of the biosafety dossier
The biosafety dossier is composed of a technical dossier and a public dossier.
The technical dossier provides for a detailed description
of the contained used activities (also including confidential data), the
infrastructure, the containment measures, the laboratory practices and
all other information allowing the technical expert to assess whether the installations
and containment measures comply with the planned contained use.
The public dossier is a non-confidential summary of the
technical dossier and can be submitted to public hearing.
The single copy of the technical dossier is sent to the SBB,
as Registered Mail or by carrier.
The public dossier is sent, at the same time as the single copy of the
technical dossier, to the SBB (which
checks, on behalf of the IBGE-BIM, the conformity of the information provided
in the public and technical dossiers). A specimen of the public dossier is
also transmitted to the IBGE-BIM by the user.
Composition of the technical dossier
The technical dossier contains the form "TECHNICAL
DOSSIER - INFO OPERATION".
This
form is used to describe in a detailed way any activity of teaching, maintenance
of collection, research and development, diagnosis, quality control, production
in small and large scale, clinical trial or any other activity performed
in the installations.
The technical dossier thus includes one form "TECHNICAL DOSSIER -
INFO OPERATION" filled-in for each activity.
Composition of the public dossier
The public dossier includes two parts:
- Part 1 corresponding to the form "ADMINISTRATIVE DATA". It includes administrative information relating to the installation as well as the plans of the laboratories.
- Part 2 corresponding to the form "INFO OPERATION". This one differs from the form "TECHNICAL DOSSIER - INFO OPERATION" in the sense that one asks only for a brief description of the activities, accessible to the general public.
The public file thus includes, in addition to part 1, one part 2 for each activity.
User guide
The technical and scientific contents of the forms and the nature of information
which is required can sometimes raise questions of interpretation.
Also,
a user guide (French and Dutch
version) was developed
in particular to clarify the use and the interpretation of the forms according
to activities of the notifier.
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