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Through The Process
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EFSA Guidance documents
Guidance documents explain the procedures and requirements for the preparation and submission of applications. They include, for instance, study protocols, list of scientific evidence to be submitted, and data requirements.
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Info Sessions on Applications
Technical meetings are arranged where EFSA scientists, EFSA experts and interested parties exchange views and discuss scientific issues related to applications for regulated products in specific areas.
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Scientific Workshops/Conferences
Workshops and conferences provide a forum for dialogue to exchange views and information on broader scientific food and feed safety issues. The scientific topics are not strictly related to applications for regulated products.
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APDESK Web form
Online form to submit administrative and scientific queries. EFSA replies within 15 working days.
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General communications activities
EFSA keeps applicants and other stakeholders informed with:
- Details about the activities of relevant Scientific Panels and Working Groups (dates, agendas and minutes of meetings are published on the EFSA website)
- Updates on the status of applications (through the Register of Questions and correspondence)
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Preparation & Submission
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Submission of applications by electronic means
Applicants submit technical dossiers and respond to requests for missing or additional information using electronic formats (CD-ROMs, DVDs or USB keys).
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Assessment
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Completeness Check
Clarification teleconference
Teleconferences can be organised upon request by the applicant following an EFSA letter of missing information to clarify the requested information.
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Risk Assessment
Clarification teleconference
Applicants can request a teleconference to clarify a request from EFSA for missing or additional information.
Applicants' technical hearing
After submitting additional or supplementary information, applicants may be invited by EFSA to attend a meeting of an EFSA working group or scientific panel to clarify issues related to the newly submitted material.
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Adoption and Publication
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Notification email on adoption of scientific output
EFSA informs the applicant that EFSA's Scientific Panel has adopted a scientific output on its application one day after adoption by the Panel.
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Pre-notification of publication
24 hours before the publication on EFSA's website, applicants and other selected stakeholders receive the adopted scientific output under embargo.
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Post-adoption teleconference
Following the publication of an adopted scientific output, a teleconference can be requested by the applicant to clarify the rationale for the decision of the Scientific Panel or EFSA and explain the evidence and other factors that influenced the outcome.
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