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Webinar: Notification of studies and Pre-submission Advice

Agenda here

25 March 2021, 14:30-16:00 (CET)

Summary

This webinar, presented by EFSA staff, introduced additional aspects of the new processes for notification of studies and general pre-submission advice, and advice on renewal.

The target audience included potential applicants, business operators and laboratory/testing facilities.

The webinar covered:

  • information to be notified
  • case study: third party contractors acting on behalf of business operators
  • case study: laboratory initiating the notification of a study and the business operator co-notifying the notification and adding it to an existing pre-application-id
  • case study: parallel notification first according to article 32c(1) and then to article 32b
  • case study: pre-submission advice: MSs involvement
  • case study: pre-submission advice: meeting organization
  • answering session: pending questions collected during the webinar held on 16th February

EFSA will publish soon an FAQ document covering questions on the Practical Arrangements (PAs). This document will conclude the feedback cycle on the PAs and will cover most questions received during the previous webinar. Therefore, the answering session of the webinar addressed only the questions not addressed either by the FAQ document, or by the webinar presentations.

Further requests for clarification on the content of the webinar and any other questions related to the Transparency Regulation should be submitted to the official EFSA support channel (servicedesk [at] efsa.europa.eu).

Presentation and recording

Please be aware that our systems are ​constantly being ​updated and improved. You may therefore find discrepancies ​between the materials shared during this webinar ​and those that are available on our website. You can find the updated user guide here:

Presentation:

Notification of Studies and Pre-submission Advice

Tutorial Videos:

3rd Party working on behalf of Business Operator

Laboratory notifies a study – Business Operator co-notifies adds notifications

Parallel notification article 32c(1) and article 32b

Pre-submission advice: meeting organisation

Disclaimer

Disclaimer and data protection note