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 holderThe answer to this question can be found on the Revisions & Renewals webpage.
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