An updated version (v3.0) of the draft guideline on the specifications for provision of an electronic submission (eSubmission) for veterinary medicinal products (Draft VNeeS guideline) is now available. The updates appearing in track-changes have been implemented mostly to align with the VMP-Regulation (EU) 2019/6. Please note that more updates will be envisaged towards October 2021 [...]
At DIA’s Global Annual Meeting on 28 June, 2021, DIA announced that it was awarding ICH the 2021 Award for Outstanding Contribution to Health.
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, the registration in Organisation Management Service (OMS) will become mandatory from the 1st of [...]
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 [...]