eAF Archives | European Regulatory Affairs Specialists

You need to apply Type IA Annual Reporting in the EU in 2025

15th April 2025

The Type IA Annual Update, also known as the “Annual report”, is a single submission of all the Type IA variations (not requiring immediate notification) which have been implemented during the previous twelve months.

The Annual report should be submitted as close to 12-month deadline as possible, but ultimately no earlier than 9 months and no later than 12 months after the first implementation date of the Type IAs included in the report.

Meaning of implementation for type-IA variations:

For quality changes, ‘implementation’ is when the company makes the change in its own quality system.

This implementation date must be carefully planned and recorded to facilitate submission of your Annual Reports.

How to plan the submission of your Annual Report:

As submission of the Annual report is dependent on the implementation of the first type IA variation, its submission date can change every year.

It is very important to note that the Type IA Annual report must fulfil the variation conditions for grouping (or super-grouping if it concerns more than one marketing authorisation).

It is expected that Type IA variations included in an Annual report will not be rejected. However, if rejected, Type IA variations from the annual report can be resubmitted as individual Type IAs immediately (outside of an annual report).

CMDh confirmed that although not specified in their guidance, Type IA variations implemented before 1 January 2025 can still be submitted as single type IA variations according to the current rules. The EMA confirmed that Type IA variations implemented in 2024 and not submitted to the Agency by 31 December may also be submitted by MAH no later than 12 months after implementation.

Therefore, Type IA variations implemented from 1 January 2025 should be submitted as part of the Annual report.

Type IAs can still be submitted outside the Annual report in the following cases:

If they are part of a grouped Type IB or Type II variation
If they are part of a super-grouping variation
If it involves the resubmission of a Type IA variation previously refused in the Annual report (12-month reporting period is criteria in this situation)
In exceptionally cases which should discussed and agreed with the EMA/NCAs.

eAF:

There are no current plans to amend the eAF to reflect Annual Reporting, instead, Applicants are advised to include a note in the cover letter and an additional note in the eAF scope to clarify that the application relates to the Annual Update of Type IA variations e.g. as foreseen in the updated Cover letter template:

<Annual update of type IA variation(s)

[X] We confirm that the annual update is submitted within 12 months following the implementation of the first type IA variation applied for in this notification. Implementation date of the first type IA variation: >

If you need any assistance with planning and submission of your Annual Reports, contact us and we will be happy to help.

Written by

Fiona Downey

Fiona Downey 1

EMA recommends use of web-based eAF for NCA submissions (PLM Portal)

14th January 2025

The expected start date of the strongly recommended use of the PLM Portal web-based eAF for submissions to the National Competent Authorities for non-Centralised Procedure (CAP) variations is now planned for February 2025.

Please note that the web-based eAF is already fully functional for the submission of variations for CAPs, including EMA-led worksharing variations containing non-CAPs.

Post-authorisation procedures submitted to the EMA will now be managed in IRIS. The transition will affect all CAPs and and non-CAPs where EMA acts as reference authority. e.g.

Worksharings with both Non-CAPs and CAPs,
Single assessments of PSURs which may exclusively pertain to NAPs
Referrals
PASS

To access the PLM Portal eAF all users are required to have:

▪ an active EMA user account, and,

▪ user access role(s) assigned to that account.

Registration needs to be done only once. For information on how to request an EMA account and how to an appropriate PLM Portal – eAF role (these are two separate actions), please consult the separate document – PLM Portal (eAF) guide to registration.pdf

This guide aims to support the users of the PLM Portal – eAF in completing the registration steps before accessing the platform. Most of these steps are independent from the PLM Portal – eAF and correspond to those to obtain registration to use other European Medicines Agency (EMA) systems, such as Management Services for Substances, Products, Organisation and Referentials (SPOR).

Once access to PLM Portal eAF is available follow the Guide for PLM Portal eAF Navigation –

PLM Portal eAF guide to navigation – eAF user guide.pdf

This guide aims to support the users of the PLM Portal – eAF in navigating through the platform. More specifically, the guide has been produced to show users how to access the PLM Portal – eAF, as well as prepare application forms.

Please note that this guide is a living document which will be updated regularly. It describes some issues in the form functionality and aims to provide workaround solutions.

Supported Browsers

The PLM Portal – eAF can be accessed on any modern Web Browser, including but has only been tested with Google Chrome (latest version) and Edge (including the new, Chromium-based Edge). No official testing has been done using other browsers, such as Safari 12 and above, Firefox (latest version), Vivaldi, etc.

If you need assistance with any of the above, contact us.

Written by Nanda Naik.

When will DADI application forms replace the current eAFs?

15th March 2022

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
Key deliverables	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 available here.
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

Points to note on the eAF

3rd February 2016

General

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.

Always check the e-submission website for the latest version of the eAF (http://esubmission.ema.europa.eu/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 Desk via 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)

Request for New Terms:
- EUDRACT terminology used
- Use eAF Term Request form to request new terms
- Send it to mdms@ema.europa.eu only
- Response should be received within 5 working days

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

You need to apply Type IA Annual Reporting in the EU in 2025

EMA recommends use of web-based eAF for NCA submissions (PLM Portal)

When will DADI application forms replace the current eAFs?

Points to note on the eAF

General

Using the eAF

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