The EMA would like to inform applicants and Marketing Authorisation Holders (MAHs) that as part of the development of the Substance, Product, Organisation and Referential (SPOR) data management services, and in anticipation to the upcoming Digital Application Dataset Integration (DADI) project replacing the PDF format eAFs, the registration in Organisation Management Service (OMS) will become [...]

CMDh position paper on the use of Mobile scanning and other technologies to be included in labelling and PL in order to provide information about the medicinal product (October 2023) [Tracked version]  - Annex 2 - Applicant's declaration template  (January 2023)

Request for RMS in a Decentralised Procedure, medicinal products for human use   Common request form (June 2023)

Implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746) 

The information paper explains the current situation about the International Organization for Standardization (ISO) standards related to the identification of medicinal products (IDMP) that are used in E2B(R3) messages (as of 16 February 2021).

Further to the ICH S12 draft document reaching Step 2b of the ICH Process, the Step 2 Informational Presentation developed by the ICH S12 EWG has been finalised.

The European Medicines Regulatory Network's Digital Application Dataset Integration (DADI) project has released a Questions and Answers (Q&A) document with further details about the purpose and scope of the project. The project team aims to follow up in the coming month with further details, including key milestones, the full list of features and the first [...]

The International Council for Harmonisation (ICH) met virtually on 2-3 June 2021 in place of face-to-face meetings that were to take place in Incheon, Republic of Korea. The meeting was preceded by virtual meetings of the ICH Management Committee and MedDRA Management Committee.

Data requested for Variations and/or Renewal Applications in the MRP/DCP which are not stated in the current EU legislation and/or in Volume 2B, Presentation and format of the dossier Common Technical Document (CTD) and/or in the EEA approved Guidelines / Recommendation papers (November 2023) [Track version]

Requirements on submissions for Variations and Renewals within MRP and National Procedures (July 2024) [Track version]