We have prepared an FAQ on Transparency Regulation. Have a look and see if you can add any of your own Questions and Answers!
The Transparency Regulation EU 2019/1381 is coming into application as from 27th March 2021. We are a sector that is directly impacted by this Regulation.
The European Commission and the European Food Safety Authority are continuing to provide guidance and training materials. Here are some useful links to follow – EFSA link and Commission link. However, we have a series of practical questions that we haven’t seen the answers yet for. We have therefore developed the enclosed FAQ document to help each other out! This document is primarily addressed for our members. We are now opening it to a wider audience. (Wherever possible we provide answers with their source.)
We are concentrating our efforts on tackling the most demanding requirements arising from the new regime:
-advanced notification of all studies to be conducted in support of a future authorisation in the EU,
-proactive disclosure of regulatory data as early as possible in the risk assessment process and stringent standards of proof to protect confidential information.
You can provide additional questions which can contribute to further clarify the implementation of this regulation by sending an email to firstname.lastname@example.org. We would be happy to receive your contribution to our FAQ on Transparency Regulation. This document will will be constantly updated until official materials are finalised (for example we have heard EFSA announcing their own QA).
We will continue to raise questions with EU authorities and responses sent from email@example.com will also be incorporated into this FAQ on Transparency Regulation.
While the EFSA platform dedicated to host all of this data is currently experiencing certain shortcomings we would like to reiterate our commitment towards the objectives of the Transparency Regulation. We welcome the extensive work done at Commission and EFSA level getting everything ready for the application date.