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Contained
Use of GMOs and pathogens
Notification forms for
the Walloon 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 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 decree of the Walloon Region foresees that the notifier submits to the
advice of the technical expert (the SBB) a risk assessment of the contained
use which proceeds inside its installation. This advice is transmitted to the
applicant. Then, the advice of the technical expert as well as the risk assessment
will be joined together to the request of environmental permit.
To build
its dossier of risk assessment, the notifier fills in only
a technical dossier which is sent to the SBB.
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 single copy of the technical dossier is sent to the SBB, as Registered Mail or by carrier.
Composition of the technical dossier
The public dossier includes two parts:
- Part 1 corresponding to the form "DONNEES ADMINISTRATIVES". It includes administrative information relating to the overall installation as well as the plans of the installation.
- Part 2 corresponding to the form "INFO OPERATION DOSSIER TECHNIQUE". 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 public file thus includes, in addition to part 1, one or several part 2 depending of the number of activities.
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 was developed
in particular to clarify the use and the interpretation of the forms according
to activities of the notifier.
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