Last updated: 27 September 2025
To view updates, click on the ‘+’ sign below.
Paediatric-use marketing authorisations
The Application process section on this page of the EMA website has been updated.
Source: EMA
IRIS guide to registration and Research Product Identifiers (RPIs)
Version 2.18 (July 2025) of this guide has been published. Industry coordinator role description in Section 5. Access to IRIS, has been updated.
Source: EMA
PLM Portal eAF – new Q&A document
A new PLM Portal eAF Q&A document is now available. The document contains questions from the most recent events (Webinars, Trainings and Q&A clinics), and will be further enhanced with more entries in upcoming versions.
It is recommended that PLM Portal eAF users consult the Q&A prior to raising a ticket in ServiceDesk, as the topic might be already explained in the document
Source: eSubmission
PLM Portal FHIR XML version upgrade
The PLM portal FHIR XML version was updated to 2.2.4 on 29 July 2025. The new version introduces the following change:
- The SPOR links in the FHIR message were changed from HTTPS protocol to HTTP, in order to be aligned with the PLM Portal systems, and to comply with the FHIR recommendations.
The existing FHIR package remains applicable.
The Release notes can be found here.
Source: eSubmission
Report and minutes from the CMDh meeting held on 22-23 July 2025
The reports from the CMDh meetings (also called press releases) reflect highlights/important outcomes of each meeting and are usually published in the week following the CMDh meeting. The reports therefore only contain a subsection of the complete CMDh agenda and are used for a more timely communication of the most important outcomes.
The CMDh minutes are a full record of the CMDh meetings (minus redaction of confidential content). They are adopted at the following CMDh meeting and subsequently published.
Acronyms and abbreviations used in the report and minutes are available here.
The report and minutes from the above meeting include (but are not restricted to) the following items:
1. Criteria for selection of products for SmPC Harmonisation
The CMDh has agreed to update the document on criteria for selection of products for SmPC
harmonisation.
- The document has been revised to clarify that only products from one MAH can be
- included in an Article 30 referral procedure for SmPC harmonisation.
- The updated document will be published on the CMDh website under “Product Information > ReferralArt. 30 and 31 (non-pharmacovigilance) > Harmonisation of SmPC – Article 30 Referrals”
A link will be provided here once it becomes available.
2. Guidance for preparation of Public Assessment Reports
The CMDh agreed on an optimised approach for preparation of public assessment reports (PARs) by providing instructions on how to convert the Final AR into the PAR.
- The agreed instructions on how to prepare the PAR will be reflected in a new template based on the updated Overview AR template.
- The new document will be published alongside an “empty” template.
- The CMDh PAR template will be maintained in the CMDh website for the RMS to choose which approach to follow.
- The new templates have now been published on the CMDh website under “Templates > Assessment Reports > Public AR” and you can view them at the links below:
3. Update of the DCP Overview Assessment Report template
The CMDh agreed an updated version of the Overview AR template.
- The template has been updated in line with the discussion on the new approach to prepare PARs (see above).
- Amongst others, it has:
- been updated in line with the requirements of the revised Environmental Risk Assessment (ERA) guideline for medicinal products for human use.
- The updated templates (empty and including instructions) have now been published on the CMDh website under “Templates > Assessment Reports > DCP (AR/Comments)” and can be viewed at the links below:
- Overview AR Template (incl. instructions), track changed (February 2025) and clean (July 2025)
- D70 Overview AR Template (empty), track changed (February 2025) and clean (July 2025)
4. Removal of eCTD sequence numbers from cover letter templates
The CMDh has agreed updates of the cover letter templates for:
- new applications,
- variations and
- renewals
as well as the MSs recommendations on the Cover Letter for new applications submitted through MRP/DCP.
With the mandatory use of a tracking table, it was decided that the eCTD sequence number in the cover letter for new applications, variations and renewals is no longer needed.
- The updated documents have now been published on the CMDh website under “Templates > Application for MA”, “Procedural Guidance > Variations”, “Templates > Renewal”, and “Procedural Guidance > Application for MA > Validation procedure”, respectively. You can view the templates at the links below:
- Cover letter template for new applications via MRP/DCP, track changed and clean (July 2025)
- Cover letter template for variations via MRP, track changed (October 2024) and clean (July 2025)
- Cover letter template for renewals, track changed (February 2023) and clean (July 2025)
- Member States Recommendations on the Cover Letter for New Applications submitted through MRP/DCP, track changed (January 2018) and clean (July 2025)
5. MRP and DCP statistics for applications started in June 2025
Below are bar charts for new applications started in June 2025 based on the data on pages 4 and 5 of the report.
6. Guidance on how to populate CTS with information on BE studies and finished
product manufacturers
Following the latest update of CTS, which now provides a field to include information on BE
studies and finished product manufacturers (FPM), the CMDh discussed a first draft for
guidance on how to populate the new fields and how the information can be used by MSs.
- MSs are expected to populate the fields by using data from the OMS database from now on.
- It was clarified that retrospective data entry is possible on a voluntary basis.
- In case a CRO is not yet included in OMS, MAHs are requested to ask for its inclusion at their earliest opportunity.
- A short-term/temporary solution will be sought for cases where the CRO cannot yet be entered using OMS (e.g. free text field).
- Cases when an update of the information in CTS is needed are specified in the guidance. It will be checked if historical information on the FPM will be available.
- An updated document will be prepared taking into account the comments raised
- The document can already be used by MSs to enter the data.
- MSs were asked to further comment on the updated document until 1 August.
- An updated version will be discussed in September.
- The document is considered an internal living document for now.
- In the future, it might be integrated into the CTS Good Practice Guide
7. Revised Variations guidelines
The CMDh agreed a clarification on the implementation of the revised Variations Guidelines.
- The CMDh expects all type IA variations implemented in 2025 to be submitted in an annual update in December 2025 or before January 15, 2026.
- Only in cases where single type IA variations are implemented after the submission of the annual update, these are accepted as individual notifications before January 15, 2026.
- The CMDh also discussed a query on how to change information on importers, considering that these changes are no longer included in the new classification guideline.
- Reference was made to the CMDh discussion in February 2022, when it was clarified that the importer does not need to be registered in the dossier and can be deleted via a type IA variation A.7.
- Similar information is also given in the EMA Q&A 2.14.
- The CMDh agreed that a new Q&A could be included in the CMDh Q&A documents on variations during the currently ongoing review.
8. Questions and answers on post approval change management protocols (PACMP) /
EMA
The EMA presented the draft revision of the Q&As on PACMP, taking into account the revised
variations guidelines.
- The CMDh and the CMDh WP on Variation Regulation have been asked to provide comments on the draft until 31 August 2025.
- QWP and BWP are consulted in parallel.
- The aim is to finalise the revision by the end of 2025.
Report: European medicines regulatory network’s response to nitrosamine impurities in human medicines
A report (July 2025) prepared jointly by the EMA and CMDh is now available outlining the the European medicines regulatory network’s response to nitrosamine impurities in human medicines.
The report:
- summarises the scientific and regulatory milestones since the discovery of nitrosamine impurities in 2018. These impurities were detected in a group of cardiovascular medicines known as ‘sartans’ and later also in other medicines.
- highlights key scientific reviews, including Article 31 reviews of sartans and ranitidine and Article 5(3) review for all human medicines under Regulation (EC) No 726/2004;
- describes the regulatory framework that manages nitrosamine impurities;
- presents advances in scientific knowledge on quality and safety of nitrosamines;
- details the harmonised approach implemented in the EU to protect patients and ensure medicine availability;
- and describes Network’s collaboration with international partners, industry, healthcare professionals and patients to ensure the continued safety and availability of medicines.
Source: EMA
Procedural advice on paediatric applications
Revision 13 (July 2025) of the guideline with the above title has been published.
Sections 6.1, 6.2 and 9 have been revised with updates relating to key elements and PDCO request for supplementary information and modification of proposed PIP (RSI) – formerly known as RfM.
European Shortages Management Platform (ESMP) updates and Q&A clinic for marketing authorisation holders (MAHs)
This EMA webinar of 24 June 2025 summarizes the “ESMP updates and Q&A clinic for marketing authorization holders (MAHs)” session. It covers:
- Enhancements to the ESMP platform, including routine shortage reporting functionality [02:17] with conditional conformance rules [02:35] and updated package identification [03:58].
- The video also highlights updated guidance documents [05:32] and a frequently asked questions (FAQ) document [05:59].
Best practices for reporting are discussed, emphasizing comprehensive information [07:16], accurate RMS terms [08:05], clarifying manufacturing issues [08:21], regular updates [09:23], correct user roles and affiliation [09:56], and open communication with EMA [11:30].
Key Q&A highlights include:
- discussions on shortage duration [15:16],
- foreign packs mitigation [16:21],
- national vs. EMA reporting [17:25],
- adding marketing authorization numbers [19:48],
- the shortage prevention and mitigation plans pilot [20:41],
- tender requests [21:51], potential shortage definition [22:58],
- discontinuation and shortages [23:56],
- products missing in PMS/ESMP [25:02],
- non-CAPs in ESMP [27:00], a decision tree on FAQ [39:09],
- consequences of not reporting [57:00],
- reporting multiple shortage periods [59:01],
- personalized ATMP medicines [59:59],
- MSSG crisis reporting [01:18:40], market share data [01:15:35], and
- temporary marketing cessation without shortage [01:19:24].
The session concluded by encouraging feedback via a Slido survey [01:22:58].
Source: EMA
IRIS guide for applicants updated
Version 3.9 (July 2025) of this guide on how to create, submit and manage IRIS applications, for industry and individual applicants has been published. The following section have been updated.
- 13.1. Create an application for initial paediatric investigation plan (PIP)
- 13.1.1 Submitting the response to Paediatric Committee request for supplementary information and modification of proposed PIP (RSI)
- 14.1 Addition of paediatric procedure format in annexes table
Source: EMA
Marketing Authorisation Application (MAA) Pre-submission interactions form (EMA)
You can access the latest version of this form (June 2025) here.
Guidelines on good Pharmacovigilance practices (GVP) updates:
- Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with new Addendum II to Module VI on masking of personal data in individual case safety reports submitted to EudraVigilance (July 2025)
- Guideline on good pharmacovigilance practices (GVP) Module VI Addendum II (July 2025) – Masking of personal data in individual case safety reports submitted to EudraVigilance
Clinical Data Publication – EU
This document is a Q&As on the External Guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use (Policy 0070).
- The aim of this document is to provide Applicants/MAHs with information they need to navigate the CDP process – to identify, redact/anonymise and submit documents -.
- The document addresses key questions on the CDP process and provides a compilation of, and references to, relevant guidance, recommendations and supportive documentation to facilitate the submission of documents in the context of CDP.
- The document will be revised regularly as more information becomes available. New questions will be marked with ‘New’ and some of the existing ones have been updated.
Source: EMA
Updated PLM Portal eAF Release notes now available
An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the version 1.2.0.9 released to production on 21 July 2025 are now available on PLM Portal and on the PLM Portal eAF web page.
Source: eSubmission
Q&A clinic on web-based electronic Application Form (eAF) functionalities for CAPs and non-CAPs variations – EMA 8 July 2025
The above was held by the EMA on 8 July 2025.
The webinar was a Q&A clinic focussed on the web-based Electronic Application Form (eAF) for PLM portal eAF users, covering both centrally and non-centrally authorized products [00:36]. The session addressed user questions and system issues [00:47].
Key topics discussed include:
- Notification Changes: A recent update moved the MRP variation number notification to the bottom of the product selection page, requiring users to scroll down to see it [02:02]. This is a temporary change [05:10].
- Mandatory Use of eAF: Mandatory use of the eAF system depends on resolving critical data dependency issues, with the earliest possible mandatory use estimated for late 2026. However, “strongly recommended use” for non-CAPs is expected in late Q3 or early Q4 this year [13:39].
- National Application Forms: The EMA is investigating the use of national paper versions of application forms to work towards harmonization [14:29].
- Multiple MAHs: Only one “reference MAH” can be selected in the PLM portal eAF when multiple Marketing Authorization Holders are involved [16:01].
- Product Data Checks: It’s recommended to check product availability in the product UI or by creating a new eAF and exporting it to prevent product corruption issues [17:12].
- National Authority Acceptance of Single MAH: If a national MA doesn’t accept a single MAH for work-sharing, users should report it immediately [18:39].
- Group Variations: For group variations affecting multiple centrally authorized products, all licenses should be selected in the PLM portal web-based application form [20:14].
- Payment Section Errors: Most payment section errors are believed to be resolved, and the payment section isn’t visible for centralized procedure applications without a fee [21:14]. A bug was noted where the VAT number field was visible for CAP products, which is not required [48:18].
- Cloning Function: While some cloning issues have been addressed, users should report systematic issues with the duplication function [22:35].
- YouTube Video Updates: YouTube videos on populating the application form are not yet updated to the new UX design but are planned for Q3 2025 [24:51]. Recordings of recent training sessions will be published soon [25:25].
- Concurrent Editing: There’s no in-system indication if another colleague is working on the same form, so external communication is advised [26:07].
- Access for Partner MAHs: Different access levels in the eAF allow collaboration between organizations [28:12].
- Automatic Updates of Draft Forms: Draft forms are generally updated automatically with new system deployments, except for major changes [30:12].
- Including Images in Present and Proposed Section: Large images can be included and appear correctly in the PDF export, despite UI display issues [32:09]. Improvements are planned [53:11].
- Signing the Form: The eAF cannot be signed directly; it’s integrity-stamped with a qualified digital signature after filling in signature details [37:22]. For a simple signature, users can print to PDF and sign a copy as an annex [38:51].
- National Training Guides: Users should check local health authority websites for specific national guidance [40:28].
- Acceptance of No Signature: CMDH is reviewing national signature requirements, and while the integrity stamp provides assurance, some countries may still require a signature [41:46].
- Validation of eAF: Users can validate sections individually or rely on the more thorough full form validation triggered by the “finalize” button [43:36].
- Signature Image Validity: Acceptance of a pasted signature image depends on the national competent authority’s requirements [44:56].
Cinical Trials Information System (CTIS) bitesize talk -EMA 9 July 2025
This CTIS Bitesize talk (9 July 2025) focuses on the redesign and simplification of the CTIS training material for sponsor users [01:58]. The main objective was to enhance the navigation and accessibility of the training material, making it more user-friendly and centralized [02:28].
Key aspects of the redesign include:
- Introduction of the CTIS Sponsor Handbook [04:18]: This handbook is now the single, unique user guidance document for sponsors, replacing all previous fragmented documents and training modules [03:40].
- Streamlined Content [02:36]: The content from all sponsor training modules has been integrated into the handbook, eliminating unnecessary duplication and ensuring consistency [04:18].
- Enhanced Navigation and Learning Tools [07:38]:
- A clickable table of contents allows users to jump directly to relevant sections [07:38].
- Step-by-step procedural guides are provided for various actions within CTIS [07:52].
- Embedded video tutorials, event recordings (like Bitesize talks), and links to external regulatory resources are included [08:01].
- Important concepts are highlighted with “important call-out” boxes [12:11].
- Cross-references are extensively used for easy navigation within the document [12:39].
- Comprehensive Coverage [06:04]: The handbook supports all phases of a clinical trial lifecycle, from pre-submission steps to application, evaluation, conduction, and conclusion of the trial [06:04].
- Modernized EMA Webpage [14:33]: The EMA webpage for sponsors has been updated, with the Sponsor Handbook as the primary reference document. The previous online training modules for sponsors no longer exist [14:58].
- Inclusion of Regulatory Resources [16:18]: While not part of EMA’s training material, fundamental regulatory documents are linked within the handbook for each topic [16:46].
The handbook is intended to be a daily reference tool for pharmaceutical industries, small and medium enterprises, academics, and CROs [13:24]. It is a dynamic document that will be updated to reflect system changes, regulatory updates, and user feedback [34:30].
Procedural advice for orphan medicinal product designation -Guidance for sponsors
Revision 18 (July 2025) of the above guide has been published.
IRIS guide for applicants – How to create, submit and manage IRIS applications, for industry and individual applicants
Version 3.8 (July 2025) of the above guide has been published.
It has been updated as follows:
- Added section 2.10 Documents from EMA and Industry in IRIS and section 2.11 Receipt date of documents from EMA
- Updated section 12.10 Re-examination
Bridging requirements for formulations in a well-establish use application
This guidance:
- has been updated in July 2025 and you can view it here.
- is aimed at further clarifying the requirements for bridging data in the context of well-established use (WEU) applications, i.e. when an active ingredient of a medicinal product has been in well-established use for at least 10 years within the Union with a recognized efficacy and an acceptable level of safety.
- This should be read in conjunction with Annex I (Part II.1) of Directive 2001/83/EC and the Notice to Applicants Volume 2A – Chapter 1 ‘Marketing Authorisation’.
Source: HMA
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
This guidance has been revised. Here, you can view the track changed (March 2025) and clean (July 2025) versions of the document.
Updates (on 15 July 2025) have been made to the following sections:
- 1.7. What is an application for a paediatric use marketing authorisation (PUMA)?
- 1.10. What should I do if I want to submit multiple/duplicate applications for the same medicinal product?
- 3.2.2. What aspects should I consider if my medicinal product has been designated as an orphan medicinal product at the time of submission of my application?
- 3.2.3. What aspects should I consider if the designation for my orphan medicinal product is still pending at the time of submission of my application for marketing authorisation?
- 3.2.6. In case the orphan designation needs to be removed, how should I proceed? – NEW question
- 3.3.4. Is my product subject to batch release by an Official Medicines Control Laboratory?
- 5.1.1. How long does it take for my application to be evaluated?
- 5.1.3. What is the QRD review of the product information?
- 6.1.5. What is the period of protection for a PUMA?
Source: EMA
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
This guidance has ben revised. Here, you can view the track changed (March 2025) and clean (July 2025) versions of the document.
Updates (on 15 July 2025) have been made to the following sections:
- 1.2. Can I (super-)group the submission of Type IA/IAIN variations? Can they be grouped with other types of variations?
- 1.4. How shall I present and submit my Type IA/ IAIN Variation(s)?
- 3.22. Can a non-orphan therapeutic indication be added to an already authorised orphan medicinal product?
- 5.4. What procedure number will be given to grouped variation applications?
- 5.6. How will grouped variation applications be handled (timetable)? What will be the outcome of the evaluation of a grouped variation application?
- 8.1. What is the pre-submission queries service?
- 19.2. How shall I present my application for the Transfer of Marketing Authorisation?
- 22.4. How shall I present my 61(3) Notification?
Source: EMA
European medical device competent authorities statement on reform of the EU regulatory framework for medical devices
The medical device competent authorities from 17 EU countries met recently in Utrecht, together with the EU Commission participating as an observer,
The purpose was to discuss the need to reform and develop further support to allow the EU regulatory framework described under the current EU Medical Device Regulations to work in a more consistent, harmonised and effective manner in practice.
The National Competent Authorities endorsed a consensus statement and shared it with the European Commission on the reform of the EU regulatory framework for medical devices. This consensus statement outlines the urgent need, and also the clear momentum, to address the topic of governance and centralisation.
The key conclusions and recommendations from the meeting are summarised below:
- Improving coordination and governance of the regulatory system at EU level is essential to address fragmentation and to improve harmonisation and as such, the governance model needs to be scientifically founded and have a strong scientific, technical and administrative secretariat support.
- A more centralised and cohesive structure is needed to support certain regulatory activities and to help provide predictability, clarity, consistency and harmonisation in the application of the requirements.
- Proportionate, patient-centred and adaptive regulatory approaches are needed to allow timely access for patients and health systems to medical technologies while also supporting the ongoing safety of medical devices in Europe together with a centralised approach.
- Simplification, clarification and removal of unnecessary burden of the Regulations is needed to improve efficiency and predictability, to provide a stable sector, and to promote EU competitiveness and to ensure equitable access to the regulatory system for all stakeholders, including micro-enterprises. Achieving this in a coherent manner is reliant on effective governance founded on regulatory science and international best practices.
- Investment in the provision of sufficient and capable resources at both a European and national level, facilitated by a sustainable funding model, is key.
- Costs associated with regulatory compliance and processes should be fair, clear, value-driven and justifiable.
- Strategic investments in the regulatory system will lead to long-term savings and a simple, clear and well-functioning regulatory system for the benefit of patients and the regulated sector.
The authorities:
- recognised the significant work being undertaken by the European Commission to deliver short term measures, simplify the system and complete a targeted evaluation of the regulatory framework.
- called on the need for a detailed plan and resource assessment to improve the governance model and to examine the potential ways that operational coordination and centralisation could benefit the system. This will require appropriate legislative supports, over and above what is described within the current Regulations.
Source: HPRA
2025 Market Review: Generics medicines markets – Policy Overview
This report published in June 2025 is divided into the following sections:
- Pricing and reimbursement system
- Control of excess spending
- Hospital tendering
- Retail tendering
- Pharmacists’ incentives
It is a very useful reference for anyone who wants to find out information concerning generic medicines in the EU (by country), under the above general headings. Information to 56 questions is presented in tables throughout the document and is easily understandable at a glance. The first 5 of the 56 questions are listed below:
- What kind of pricing system is in place for generic medicines (reimbursed)?
- How often are prices adjusted in your country (months)?
- When price adjustments occur, can prices be revised upward, or only downward?
- Which criteria is used to set the prices
- Countries using external reference pricing (ERP) to set prices:
2025 Market Review: Biosimilar medicines markets – Policy Overview
This report published in June 2025 is divided into the following sections:
- Availability
- Pricing and reimbursement system
- Control of excess spending
- Hospital tendering
- Retail tendering
- Economic prescribing and dispensing policies
- Governing policies
- Information and education
It is a very useful reference for anyone who wants to find out information concerning biosimilars (specifically the 26 biosimlars listed on page 4 of the document) in the EU (by country), under the above general headings. Information to 75 questions is presented in tables throughout the document and is easily understandable at a glance. The first 5 of the 75 questions are listed below:
- Which of the following biological active substances are biosimilar medicines available in your country?
- In which setting, or settings, are the biosimilar medicines available? (H: Hospital pharmacy – S: Specialised centres – R: Retail pharmacy – O:Other – A:All Settings)
- What kind of pricing system is in place for biosimilar medicines (reimbursed)?
- Which criteria is used to set the prices?
- How often are prices adjusted in your country?
Source: Medicines for Europe
Training session on Human variations web-based electronic Application Form (eAF) for non-CAPs
This EMA training webinar was held on 1 July 2025. A summary with timestamps is provided below.
The webinar provides a comprehensive overview of the web-based Electronic Application Form (eAF) within the PLM portal, specifically for non-centrally authorized products (non-CAPs). The session covers the different sections of the form, recent changes, and includes a Q&A segment [01:09].
Key points discussed include:
- Transition to Web-Based eAF: The video highlights the move from outdated interactive PDF eAFs to a modern web-based input form, which offers faster opening times, machine-readable XML output (in Fire format), and improved digital processing [05:27].
- Structured Data and PMS Integration: The new form utilizes ISO IDMP and Fire compliant structured data, retrieving product information directly from the Product Management System (PMS) [07:08]. This enables a two-way exchange of data, ensuring better data quality across processes [07:56].
- Key Changes and Features:
- Implementation of new UX designs and performance improvements [13:57].
- Ability to use alternative company names from MS [14:04].
- Fixes in sections 4A and 4B [14:14].
- Automatic calculation of procedural information, such as concerned member states [42:34].
- New features like cloning scopes for easier duplication [40:26].
- A pop-up notification for unsaved changes [53:33].
- Known Issues and Limitations:
- Usage and Support:
- The web-based eAF is currently recommended but optional for non-CAPs, with a fallback to the interactive PDF if technical issues arise [12:20].
- All National Competent Authorities (NCAs) now accept the web-based eAF [15:04].
- Users are encouraged to report any issues or provide feedback via the EMA service now tool [14:48].
- A Q&A session is scheduled for July 8th to address further questions [03:09].
- Demonstration Highlights:
- Creating a new application form and naming it [25:05].
- Selecting the reference Marketing Authorization Holder (MAH) [25:21].
- Adding products, with a new limitation of selecting no more than 50 products at a time for performance reasons [30:41].
- Associating MRP numbers to products [35:33].
- Selecting procedure types and scopes [39:09].
- Adding proposed changes and organizational details [50:23].
- Filling in the declaration of the applicant and payment details [54:08].
- Finalizing and exporting the form, which looks similar to the interactive PDF eAF with an integrity stamp [59:08].
The video emphasizes that while the web-based eAF is strongly recommended, the interactive PDF remains an option until all known issues are resolved and the system is fully transition-ready [01:16:11].