Marketing Authorisation Applications for human use submitted using the Decentralised Procedure (DCP) will need to be provided electronically as eCTD by Q3 2015. Submission in eCTD for Mutual Recognition Procedures (MRP) will also be required by the start of 2017, and finally National Procedures by the start of 2018. eCTD is already required for Centralised Procedures.
The EMA also announced at the end of 2014 that Veterinary Drugs must be filed electronically starting in 2016 for CP/DCP, and all submissions by 2017 by VNeeS (Veterinary Non-eCTD Electronic Submissions).
Plans are also underway to replace the Microsoft Word-formatted application form with the eAF (Electronic Application Form) and the deadline will be Q1 2016. Further detailed guidance can be found under the following links:
Ivowen are fully eCTD-ready and compliant. Please contact us for more information and for support of your electronic applications.
Written by Laura Oakey
https://eureg.ie/wp-content/uploads/2023/10/European-Regulatory-Affairs-Logo.svg00ERAadministratorhttps://eureg.ie/wp-content/uploads/2023/10/European-Regulatory-Affairs-Logo.svgERAadministrator2015-04-21 11:31:322023-11-06 11:08:14New EU MA Applications will require eCTD Submissions by Q3 2015
The eAF is mandatory for all procedures from 01/01/2016 (CP, MR, DC, National in eCTD/NeeS/Paper). However, Presubmission Meeting Requests, Article 61(3) & MAT forms remain the outside scope and can be submitted as paper or PDFs.
Please contact us if you require any assistance with any of the forms or any advice on any of the above procedures. For your convenience, the following is a summary of the important aspects of using the eAF.
Word versions will be removed from Notice to Applicants in January 2016
After 11/01/2016 only version 1.19 will be acceptable for new procedures
eAF should be printed for Paper submissions
Version 1.20 is planned for April 2016 (unless hotfixes are required before then)
It is important to note, and welcome news, that there is no need to update to a newer version of the eAF in the middle of a procedure
See the guidelines (update planned in January 2016) and release notes (lists the changes made to newer versions) for further information
In line with the proposed move towards a Single Submission Portal (SSP) in place of CESP and the EMA Gateway, there are plans to reformat the eAF into a data capture system that can be submitted directly through CESP. This is in a very preliminary stage.
Technical queries should be sent to EMA Service Deskvia IT service portal (login)
Q&A documents should be consulted first
Fast web view warning in the dossier validation report for the eAF can be ignored
Procedural queries should be directed to the National Competent Authority (NCA) (and response sent to EMA Service Desk). Complicated queries should be sent to both parties.
Webinars are available for the NCAs (to try to reduce the requests for MS specific national requirements)
Using the eAF
Technical Validation of the form (internal):
Once signature is added and form validated, it is now locked. Locked forms cannot be amended. Therefore, the signature should be the last thing added to the form.
Always keep a copy of the unlocked form so that amendments can be made (e.g. during preparation or for requests from NCA for updated forms during a procedure)
Do not use bookmarks as these may cause invalidation issues
Annexes to the form should be filed separately in module 1.2 (do not use the PDF function to insert them into the eAF)
Form should be named; cc-form-eaf-var
Annex should be named; cc-form-annex-var (e.g. cc-form-5-19 or cc-form-proofpayment)
Electronic signature can be an image of a real signature (e.g. jpeg file – a scanned copy of wet signature. This however is not an electronic signature and is only used to close/lock the form) or can also be a line of text which states that signature is on file internally (e.g. “This form was authorised following company policies by Majella Ryan, Regulatory Affairs Manager of Ivowen with authorisation to sign. The signature is on file”)
The eAF does not accommodate multiple signatures at present. A separate annex should be provided if multiple signatures are mandatory for a particular NCA. Multiple name sections will be incorporated into version 2.0 but no mention of whether multiple signatures will also be accommodated.
The signature should be provided by the responsible MAH or can be provided by any authorised deputy
Please also check national requirements for signatures.
See Q&A guidance for further information
Workaround solutions (e.g. Annex B for multiple MAH or Product names) should always be mentioned in your cover letter
Some unforeseen variations (category z) are not adequately accounted for yet. Details of such changes should be outlined in the scope section of form and in the cover letter.
Duplicate sections only if products differ with regard to API or Pharmaceutical Form
Annex A or Annex B can be used for multiple MAH or Product names. Click on Annex A/B button in form and add the annex as a separate file in Module 1.2
Detailed instructions on how to use workaround solutions is available in the eAF Q&A document and the eAF Technical Guidance documents – both are published on the eAF webpage – if you need more advice contact EMA Service Desk.
No translations of the eAF are available, nor should they be requested.
Drug substances can be entered from controlled vocabulary lists or free text, and these each have different EV codes.
The focus should be on using substance, product, organisation and referential (SPOR)
Strikethrough text function is not available in eAF but text can be copied and pasted (with text struck through) from Word or Outlook
In MRP/DCP one common application form is highly recommended, one per pharmaceutical form or strength for all member states in case of new MAA and one eAF for all involved products for all member states in case of variations and renewals.
Written by Majella Ryan
https://eureg.ie/wp-content/uploads/2016/02/eSub-roadmap-eAF-02-2016-1.png681925ERAadministratorhttps://eureg.ie/wp-content/uploads/2023/10/European-Regulatory-Affairs-Logo.svgERAadministrator2016-02-03 16:03:552023-11-06 11:08:23Points to note on the eAF
The electronic application forms (eAFs) we are familiar with are in the process of being replaced later this year by a web based digital application form in a new eAF portal. The new eAF portal will look somewhat similar to the current IRIS portal.
This project, known as DADI (Digital Application Dataset Integration), is intended to be used for both CAP (Centrally Authorised Products) & NAP (Nationally Authorised Products) applications to make the future of form-filling and submission-handling more efficient at an EU level.
The Human medicinal product Variation application form will be the first to go live in DADI format. Every person involved in drafting an eAF will need to have an EMA account and user access. Companies who use consultants to prepare eAFs will need to make sure that they assign an EMA role to the consultant.
The next stages of DADI will cover the
Veterinary variation application form
Initial MAA form for Human and Veterinary products
Renewal form for Human and Veterinary products
How will it work?
The eAF will be filled in using the new eAF portal (via user interface).
The user will then finalise the eAF by generating a PDF rendition
This PDF version must still be included in the eCTD submission, as before.
It will not be possible to submit the form directly from the eAF portal
When will it happen?
As outlined in the EMA roadmap (link provided below) the two immediate key deliverables are as follows:
Key deliverables
Go-Live Time Lines
Year
Quarter
Launch of Human variations web-form (parallel use of old and new variation forms as part of a Transition period)
2022
Q4 (October)
Use of variation web form only
2023
Q2 (April)
It is important for all industry stake-holders to keep up to date with the development of these new web-based forms by consulting the EMA website for updates at the various launch stages.
Where can I find information?
DADI Network Project Webinar – 18/01/2022 – Live broadcast is availablehere.
The updated DADI roadmap, including key milestones, is available here.
The updated version of the DADI Questions and Answers documents is available here.
The “Common factors in the Fast Healthcare Interoperability Resources (FHIR) data standard for Art57(2) and eAF”documents are available in the following link.
The project will be implemented in phases, through a set of projects known as SPOR (Substances, Products, Organisations and Referentials) data management services for Human products. The Union Product Database will be the source of data for Veterinary products.
What is SPOR?
SPOR datasets
Description of data types
Status
Substance Management Services (SMS)
Harmonised data and definitions to uniquely identify the ingredients and materials that constitute a medicinal product.
Under Development
Product Management Services (PMS)
Harmonised data and definitions to uniquely identify a medicinal product based on regulated information (e.g. marketing authorisation, packaging and medicinal information).
Under Development
Organisations Management Services (OMS)
Data comprising organisation name and location address, for organisations such as marketing authorisation holders, sponsors, regulatory authorities and manufacturers.
Operational
Referentials Management Services (RMS)
List of terms (controlled vocabularies) to describe attributes of products, e.g. lists of dosage forms, units of measurement and routes of administration.
Operational
Once the above PMS and SMS are in place, pharmaceutical companies should start preparing to replace their current data submission format in Article 57 Database from the eXtended EudraVigilance Product Report Message (XEVPRM) format to the new ISO IDMP compatible format (HL7 FHIR). Webinars and training will be provided by EMA in due course.
What do Marketing Authorisation Holders have to do at this stage?
Marketing authorisation holders need to check their data in SPOR (OMS) to ensure it is accurate and up to date. For CAPs the use of OMS data in the current eAF is already mandatory.
Marketing authorisation holders with authorised MA(s) need to check their data in Article 57 database (xEVMPD) to ensure it is accurate and up to date.
Should you need any support at this stage in getting ready for the new Application Form format please feel free to contact us & the Ivowen team will be here to help.
Written by Marian Winder
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