When should the applicant request a renewal?

Answer:

According to Resolution AP-CSP (07) 1, a certificate of suitability (CEP) is valid 5 years and it is the responsibility of the holder of the certificate to ask for its renewal about 6 months prior to the expiry date of the certificate. Any requests sent later may lead to a gap between the expiry date of the certificate and the approval of the request for renewal, during which no valid certificate would be available.

In the absence of a request of renewal in due time, i.e. before the end of its 5-years validity date, the certificate will definitively expire , this will be mentioned in the published list of certificates and a new application would then have to be submitted to obtain a new certificate for the same substance.

For CEPs, a system similar to one introduced in the Directives 2004/27/EC and 2004/28/EC for the renewal of marketing applications for medicinal products has been implemented; this means that a CEP is renewed once, and then it is valid for an unlimited period, provided the related dossier is kept up to date by the holder.