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Contained
Use of GMOs and pathogens
Notification forms for
the Flemish 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 "Leefmilieu, Natuur, en Energie" (LNE), 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 any administratve
step, the notifier is invited to consult the Division
of Biosafety and Biotechnology about the technical features of the installation
and the scientific aspects of the contained use.
Following this consultation, a certificate of consultation can be established
by the SBB and given to the notifier.
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 relevant authority,
the conformity of the information provided in the public and technical dossiers).
A specimen of the public dossier is also transmitted by the user to the relevant
regional competent authority.
Composition of the technical dossier
The public dossier includes two parts:
- Part 1 corresponding to the form "ADMINISTRATIEVE GEGEVENS". It includes administrative information relating to the overall installation as well as the plans of the installation.
- Part 2 corresponding to the form "INFO ACTIVITEIT TECHNISCH DOSSIER". 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.
Composition of the public dossier
The public dossier includes two parts:
- Part 1 corresponding to the form "ADMINISTRATIEVE GEGEVENS". It includes the same information as part 1 of the technical dossier.
- Part 2 corresponding to the form "INFO ACTIVITEIT PUBLIEK DOSSIER". This one differs from part 2 of the technical dossier in the sense that one asks only for a brief description of the activities.
In addition to part 1, the public dossier thus contains, depending of the number of activities, one or several specimens of part 2, which correspond to the number of activities notified in the technical dossier.
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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