CMDv validation list for Renewals of veterinary medicinal products (RMS) Note: this check list, once filled in by the RMS should be sent before the start of the validation phase, i.e. at day -14 if the dossier was received in advance in the RMS. Otherwise the RMS should send it between day -14 and day -10 at the latest. In any case, the CMS should be informed about the expected date at which they should be in receipt of the check list. IDENTIFICATION OF THE PRODUCT Procedure number Product (invented) name Applicant (name) Date of submission: Date of first authorisation in Reference Member State/EU: Proposed Common Renewal Date: Nature of the renewal procedure Administrative renewal ? Yes ☐ No ☐ If yes : RMS comments Documents appended to this application Valid Invalid N.A. 1.0 Cover Letter ☐ ☐ ☐ PHYSICAL CHECK Electronic submission: CESP CD/DVD Eudralink ☐ ☐ ☐ ☐ CESP Number: Eudralink date of submission: – ☐ Paper copy submission Are all the volumes present and contents Yes No ☐ ☐ presented in an acceptable format?
CMDv validation list for Renewals of veterinary medicinal products (RMS) Note: this check list, once filled in by the RMS should be sent before the start of the validation phase, i.e. at day -14 if the dossier was received in advance in the RMS. Otherwise the RMS should send it between day -14 and day -10 at the latest. In any case, the CMS should be informed about the expected date at which they should be in receipt of the check list. IDENTIFICATION OF THE PRODUCT Procedure number Product (invented) name Applicant (name) Date of submission: Date of first authorisation in Reference Member State/EU: Proposed Common Renewal Date: Nature of the renewal procedure Administrative renewal ? Yes ☐ No ☐ If yes : Documents appended to this application RMS comments Valid Invalid N.A. 1.0 Cover Letter ☐ ☐ ☐ PHYSICAL CHECK ☐ Electronic submission: ☐ CESP ☐ CD/DVD ☐ Eudralink CESP Number: Eudralink – date of submission: ☐ Paper copy submission Are all the volumes present and contents presented in an acceptable format? Yes ☐ No ☐
Renewal_validation_checklist_RMS_MRP-DCP.docx