Chapter 3: Process for the electronic submission of medicinal product information
Summary of changes
After the release of version 2 of this guideline, important discussions took place which led to significant changes in the information provided. As a result, version 3 of this document has been completely revised, and previous versions should no longer be taken into consideration.
This update reflects changes that have been made based on feedback and new developments in the field, with the aim of providing the most up-to-date and accurate guidance possible.
It’s important to note that this guideline will continue to be updated as necessary to reflect any changes to the processes described below. This ensures that the guidance remains current and relevant to industry and NCAs practices, and that users are always working with the latest information available.
Version 3.1 of this guidance provides the full list of MBOs to be submitted to PMS as part of the enrichment process.
Version 3.2 includes an additional MBO that was missing in the previous version. This MBO (Bioequivalence Contract Research Organisation (CRO)) is part of the eAF but will also be used to support the referrals process. Additionally, some notes were included on the manufacturers and Data Carrier ID sections to provide some useful information to MAHs.
Version 3.3 includes the change of the conformance of the Medicines Regulatory Agency Organisation. It changed from mandatory to conditional. It shall be provided when the Manufacturing Authorisation Reference number is provided, otherwise, it is optional.
Additionally, some notes were included on the MBO start and end dates.
Furthermore, version 3.4 includes an improvemed MBOs section with additional information clarifying which business operations should be submitted by MAHs as part of the enrichment process.
Version 3.5 has been released to update the MBOs section to include two new MBOs that were included in the RMS list (Quality control of Master/Working Cell Bank or Virus Seed and Preparation of Master Cell Bank and/or Master Virus Seed). Additionally, the term Physical importation has been removed as it is not relevant anymore. Additional clarifications are made in the same section.
Version 3.6 explains that, for the Manufacturer Authorisation Reference Number, MAHs are allowed to submit the value To be provided in case it is not known. Nevertheless, the correct value should be provided before the end of December 2026.