CRED ERP 25

6. Managing the Procedure: DCP

Preparing Product Dossier The submission is made simultaneously to the RMS and each CMS. Prior to the actual submission, the applicant may request a pre- submission meeting with the RMS to familiarise them with the product information and submission details. The product dossier is sometimes not validated by some MSs for a variety of reasons including lack of original, signed documents, lack of nationally required documents, wrong dossier format, e.g., not in eCTD format, or technical issues related to the eCTD. After the submission is made, the validation period begins. Assessment Report Review When the submission is made to the RMS and CMS the validation should take 14 days, though in reality this may take longer depending on the validation issues raised by the RMS and Concerned Member State and the quality/completeness of the dossier submitted. It is important to check the respective documents on the CMDh website to avoid many validation issues, e.g., CMDh has published the RMS and CMS validation checklists so the applicant can perform their check of the dosser before submitting the application. When the submission is made, the RMS initiates the procedure in the Communicationand Tracking System (CTS) database. This allows communication about the procedure between the Reference Member State and Concerned Member States.

The applicant must respond daily to deficiencies to have the submission successfully validated between each of the Member States identified. Once validation of the application is obtained, then the procedure is started. Two Stage Process DCP is a two-stage assessment process that has strict timelines that must be adhered to: 1) Assessment Step 1 corresponding to the period until the Draft (day 120) Assessment Report is prepared, and 2) Assessment Step 2 where comments are resolved and consensus is achieved. The Reference Member State prepares the Preliminary Assessment Report (PrAR) at day 70 and circulates to each Concerned Member Stateand applicant.