EFSA’s dedicated support for SMEs 24 May 2019 EFSA’s dedicated support for SMEs Remigio Marano APDESK Unit Patricia Romero APDESK Unit

Q&A box: For any questions related to the topic Webinar guide for attendees This webinar is being recorded! The webinar is in English and questions should be submitted in English through the platform (see hereunder). You are automatically connected to the audio broadcast. One-way audio (listen only mode). Presentation window Q&A box: For any questions related to the topic

Objectives of the webinar: INTRODUCTION Objectives of the webinar: Present the new targeted activities that are available for SMEs. SMEs can propose suggestions and ideas to better address their needs in relation to regulated product applications The webinar and Q&A will NOT address: Advice on specific applications as well as planned or already provided support Advice on particular scientific matters Questions related to the legal framework and risk managers competencies Questions on e-tool of DG-GROWTH (SME self-assessment questionnaire)

Outcome of the webinar: INTRODUCTION Outcome of the webinar: WE WILL PUBLISH: Final agenda Presentation Webinar recording WE WILL NOT PUBLISH: Log of questions and answers

EFSA’s dedicated support for SMEs 24 May 2019 EFSA’s dedicated support for SMEs Remigio Marano APDESK Unit Patricia Romero APDESK Unit

Webinar on EFSA’s support to SMEs OUTLINE Webinar on EFSA’s support to SMEs Introduction to EFSA’s support to SMEs Requirements for participants New targeted activities: Administrative support Monitoring of applications Fast processing of queries Official register of SMEs Interactive Q&A session

INTRODUCTION APDESK is the unit in EFSA dealing with applications of Regulated Products The catalogue of initiatives provides an overview of the support activities available for applicants, Member States, universities, NGOs, etc. SMEs are a group of applicants with special needs Pilot project on “Pre-submission administrative check of draft dossiers submitted by SMES” On-going work to develop targeted services for SMEs

NEW TARGETED ACTIVITIES FOR SMES Administrative support Monitoring of applications Fast processing of queries Official register of SMEs

REQUIREMENTS FOR PARTICIPANTS Companies fulfilling SMEs EU Recommendation 2003/361/EC For SME consultant will only apply when representing a SME company To prove the SME status: self-assessment questionnaire http://ec.europa.eu/growth/tools-databases/SME-Wizard/smeq.do;SME_SESSION_ID=-al9JO2hkpxEA7fUjpkP8dWd5V1Ich--PkRwSDFLLDoqq1cXckzR!-261302819?execution=e1s1

REQUIREMENTS SME STATUS ASSESSMENT Final report Save as pdf and Sent to SMEoffice@EFSA.europa.eu

NEW TARGETED ACTIVITIES FOR SMES Administrative support Monitoring of applications Fast processing of queries Official register of SMEs  

NEW TARGETED ACTIVITIES FOR SMES Administrative support

NEW TARGETED ACTIVITIES FOR SMES Administrative support Direct assistance provided by APDESK staff on any administrative aspects related to the preparation of an application of a regulated product Support on applicable EFSA guidance documents, workflows, procedures, information needed etc. Scientific and regulatory advice are out of the scope of this activity Dedicated email: SMEoffice@EFSA.europa.eu EFSA staff APPLICANT

NEW TARGETED ACTIVITIES FOR SMES Monitoring of applications

NEW TARGETED ACTIVITIES FOR SMES Monitoring of applications Follow-up of applications submitted by SMEs Reminder emails Workflow with the current status of the application Clarification phone call if needed EFSA staff APPLICANT

MONITORING OF APPLICATIONS

NEW TARGETED ACTIVITIES FOR SMES Fast processing of queries

NEW TARGETED ACTIVITIES FOR SMES Fast processing of queries Responses to request through ”Ask a question” tool in max 7 working days Phone call for clarification if needed APPLICANT EFSA staff

NEW TARGETED ACTIVITIES FOR SMES Official register of SMEs

NEW TARGETED ACTIVITIES FOR SMES Official register of SMEs Establish an internal EFSA register of SMEs made of companies that are interested on EFSA’s work and activities List of contacts for the development of future initiatives EFSA staff

EFSA’s SUPPORT FOR SMEs 24/05/2019 Q&A

Thank you for attending our webinar! In case we did not manage to answer all your questions, please feel free to re-submit them via e-mail SMEoffice@efsa.europa.eu Please take 5 more minutes to fill out the evaluation form that you will receive shortly in your inbox. Your feedback will help us improve our service!