Your team and you thoroughly and diligently worked on data generation, prepared the registration package and submitted the product application to the EC, EFSA, and EURL. You successfully passed the dossier validation and shared the happy news with your management and board. Everything is going according to your plan. Until few months into the EFSA evaluation, you receive the supplementary information request. What? Why? How is it possible? What to do now? Mirka Piskorikova
Receiving the supplementary information request is very common. Take a deep breath and read the EFSA request carefully. It can be anything from confirming the product composition, clarifying data on method validation, to providing additional information to support product safety or efficacy. Don’t forget to inform your management as it’s likely to delay the product approval and launch.
Check the submitted information related to EFSA request
It’s important to get familiar with relevant information and see how you can respond to the request. Involve people who provided this information and consider them to be great source of knowledge, expertise and solutions. Also, they are familiar with the topic.
Check the deadline
EFSA indicates the deadline by which the supplementary information must be provided. Don’t be afraid to ask for the deadline extension if you have a justifiable reason for it.
Acknowledge receipt of supplementary information request
Contact the assigned EFSA Scientific Officer and confirm that you have received the supplementary information request. Indicate if you can provide the requested information by the established deadline. If not, request the deadline extension. Ask for clarifications related to any of the questions, if needed.
Prepare a response plan
It’s crucial to have a clear project plan to keep track of who is doing what to meet rather tight timelines and EFSA/management expectations. Have regular project calls and address any upcoming issues and delays.
Compose and submit the response
Use the request letter as a template for the response to EFSA questions. Follow them in the same order. Answer the questions and justify a company position on the requested topics. Be clear and consistent. Use tables to summarize information (reviewers like to see things visually, and it’s an easy way to capture and highlight important points).