Current issue of “RMS NEWS”

messages in brief | 30/09/2022

NEWSTICKER 30.09.2022

Project „Digital Application Dataset Integration (DADI)“: Step-by-step introduction of a web-based tool for the preparation of electronic Application Forms (eAF) to replace the current PDF input. EMA plans to launch the eAF web form for variation applications for centrally authorised human medicinal products in October 2022.The scope of the October 2022 go-live will be limited to variation applications of centrally authorised human products (CAPs). Therefore, this version of the web-based form cannot yet be used for variation applications that include nationally authorised products (NAPs), including national procedures, MRPs, and DCPs.

In subsequent versions, the eAF portal will be continuously expanded. In the next step - planned for March 2023 - all types of EU variation procedures (CAPs and NAPs) will be supported. This will be followed by the provision of the web-based form for new applications and renewals. Up-to-date information can be found in an EMA Q&A document from a webinar on July 12, 2022 and will also be published on the eSubmission website.

RECENT COMMITTEE NEWS

Update RMS Validation Checklist for human medicinal products in DCP. The CMDh has updated the RMS validation checklist in DCP. The information on the documents to be submitted for the risk assessment of the potential presence of nitrosamines has been added to the list of "non-validation issues" (i.e., the RMS can start the procedure even though the issues have not been resolved on Day 0). Further, it was decided that "non-validation issues" must already be resolved by the applicant by Day 30. A corresponding update of the "CMDh Procedural Advice on Validation of MRP/RUP/DCP" and the CMS validation checklist in the DCP was agreed upon. The updated documents have been published on the CMDh website here.

Update CMDh Guidance Document on Informed Consent Applications. The CMDh agreed to update the guidance document "Recommendations on Informed Consent Applications in MRP and DCP". The document was revised with regard to readability and supplemented with recent CMDh agreements and a new section on the lifecycle/maintenance of the dossier after authorisation.

Similarity report – new template for applicants. The CMDh agreed a new template for applicants to prepare their report on potential similarity with authorised orphan medicinal product(s). The template has to be used for submissions as of 1^st November 2022, but it can already be used before that date on a voluntary basis. See the recent press release from the CMDh September 2022 meeting for further details.

Applicant’s response – new template for type II variations. The CMDh agreed a new template for applicants to provide their responses to questions in the Preliminary Variation Assessment Report and CMS comments within type II variation procedures. The template has to be used for submissions as of 1^st November 2022, but it can already be used before that date on a voluntary basis. See the recent press release from the CMDh September 2022 meeting for further details.