Borderline and Classification Work Group â Introduction - TOPRA
Borderline and Classification Work Group â Introduction - TOPRA
Borderline and Classification Work Group â Introduction - TOPRA
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How to Progress a <strong>Borderline</strong> or<br />
<strong>Classification</strong> Issue<br />
• Prepare a position paper with a reasoned case for your proposal<br />
• Discuss issue with relevant Competent Authorities <strong>and</strong> attempt to resolve the<br />
issue<br />
– CAs may invoke the “Helsinki” process where case discussed by correspondence<br />
among all CAs<br />
– Sometimes all that is needed to reach a conclusion<br />
• If there are conflicts collect all written evidence of various positions<br />
• Hawk it around with your request for consensus<br />
– <strong>Work</strong> with your Trade Association to put the case on the <strong>Work</strong>group Agenda<br />
– Lobby your Competent Authority to seek consensus at <strong>Work</strong>group level<br />
– Contact the <strong>Borderline</strong> <strong>and</strong> <strong>Classification</strong> <strong>Work</strong>group Secretariat to make the case<br />
Céline BOURGUIGNON <strong>and</strong> Aurélien PEREZ, PharmD.,<br />
European Commission , Enterprise <strong>and</strong> Industry Directorate-General<br />
Unit F3 - Cosmetics <strong>and</strong> Medical Devices, Office BREY 10/159<br />
45 Avenue d'Auderghem, B-1049 Brussels, Belgium<br />
Tel.: +32-2-2969362, Fax: 66 467 email: aurelien.perez@ec.europa.eu<br />
The Organisation for Professionals in Regulatory Affairs<br />
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