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Iceland Drug Product Registration

Release Notes for the eSubmission Roadmap

Regulatory Authority: Icelandic Medicines Agency (IMA)

Link for Regulatory Authority: https://www.ima.is/home/pricing-and-reimbursement/

MoH Email: [email protected]

Local Authorised: Yes

Registration Timeline: 210 days national, 90 days MR

Registration Fee:

  • Application Fee:
    • National Procedure: €5,600
    • MR/DC Procedure: €2,800
  • Annual Fee:
    • National Procedure: €1,400
    • MR/DC Procedure: €700

License Validity: 5 Years

 

Main updates compared to version 2.1

eCTD v4.0

eCTD v4.0 transition timeline was put in place earlier but is now on hold pending a review of the overall network-wide strategy and plan. The timeline will be re-confirmed after this aligned strategy is discussed and agreed upon. But the limited context makes it difficult to provide a more complete interpretation. More background information would help clarify the circumstances fully.

eGateway, CESP, eAF, Single Submission Portal

CESP implementation is proceeding in a phased manner from 2020-2021 for different application types. The mandatory single submission portal timeline is still to be finalized based on the broader network strategy. A common service desk will also be implemented incrementally through Q1 2021.

Other updates

The roadmap document version 2.2 has also been updated to reflect the already achieved milestones (Done) and a few minor changes have been made, e.g. to include some reflections on current situation and the new veterinary legislation issues.

Roadmap

The eSubmission vision will be implemented through a strategic roadmap that outlines key actions and estimated timeframes for completion, contingent upon resource availability within the Network and alignment with other EU Telematics priorities. While the roadmap doesn’t encompass all activities necessary for the long-term vision, it focuses on pertinent tasks and timelines for the immediate future. Further specifics for each area, delineating the prerequisites for utilizing and achieving the deliverables, will be deliberated within the eSubmission Expert group. Subsequently, this information will be disseminated to the entire network and stakeholders at an appropriate juncture.

Area

Objectives

Action

Deliverable

Timeframe

Submission format (Human use)

 

Streamline the handling of submissions and life cycle management.

 

Require single electronic format for applications of medicinal products for human use.

 

·        eCTD only for New MAA’s in DCP

 

·        eCTD only for New MAA’s in MRP

 

·        Done

 

 

·        Done

 

 

 

·        eCTD only for all submissions in EU procedures (Note: baseline submissions are not required)

 

·        eCTD only for New MAA’s submissions in National Procedures (Note: baseline submissions are not required)

 

·        eCTD only for all submissions in National Procedures (Note: baseline   submissions are not required)

 

·        Planning and preparing for implementation of eCTD v4.0

 

·        Optional use of eCTD v4.0 in CP (timeline subject to outcome of the planning exercise)

 

·        Optional use of eCTD v4.0 in MRP and DCP (timeline subject to outcome of the planning exercise)

·        Done 

 

 

 

 

 

 

·        Done

 

 

 

 

 

 

 

 

·        Done

 

 

 

 

 

 

 

·        Ongoing (see Annex 1)

 

 

 

·        To be decided as a part of network strategy (human)

 

 

·        To be decided as a part of network strategy (human)

Submission media and transfer mechanism (Human and Veterinary use)

Eliminate all physical media and implement single submission form

Implement Single EMANCA eSubmission Portal

·        Mandatory use of EU Single Submission Portal for all submissions

 

·        Mandatory use of CESP portal for delivery of MRP/DCP submissions

 

·        Mandatory use of the Common Repository for transmission of all CP submissions

 

·        Mandatory use of Common Repository for all other EMA led EU procedures (e.g. NAPs included in EMA led WS variations, see Annex 5

 

·        Mandatory use of the Common Repository for transmission of all veterinary submissions in CP

 

·        Mandatory use of Common Repository for veterinary EMA led work-sharing procedures involving NAPs (Common Repository to be extended for Vet WS procedures)

 

·        Implement PSUR Repository in line with the new PhV regulation (human only)

 

·        Mandatory use of the PSUR Repository (for Industry and NCAs) (human only)

·        To be decided as a part of network strategy

 

·        2019 Q3

 

 

 

 

 

·        Done (human)

 

 

 

·        Done (human)

 

 

 

 

 

 

 

·         Done

 

 

 

 

 

 

·        2020 to be confirmed by EMA.

 

 

 

 

 

 

 

 

 

·        Done

 

 

 

 

 

·        Done

Content requirements (Human and Veterinary use)

Harmonised handling of content of eSubmission to the Network

Agreed handling of eSubmission for specific national documents and regulatory activities

·        Update eSubmission guidance together with relevant regulatory groups (CMDh, CMDv)

 

·        Implementing mandatory eCTD for all EU procedures (human only)

·        Done

 

 

 

 

 

 

 

·        Done

Content format (Human and Veterinary use)

 

Enable automated extraction of data into database.

 

Complete the technical restructuring of eAF.

 

·        Step 1: Replace current AF template in word format published by the Commission with eAF for CP.

 

·        Step 2: Replace current AF template in word format published by the Commission with eAF for all procedures.

 

·        Establish a new Telematics Service Desk that covers support tasks on all Telematics system within the EU Network.

 

·        Step 3: Use of CESP dataset module for Human and Vet new MAA application forms

 

·        Done

 

 

 

 

 

 

·        Done

 

 

 

 

 

 

·        2021 Q1 Stepwise implementation first approach with support model for CESP/eAF

 

·        2020 Q2 (optional)

·        2021 Q1 (mandatory)

 

 

 

 

·        Step 4: Use of CESP dataset module for variation and renewal application forms

 

 

·        Preparation for the mandatory use of the integrated application form and submission for all submissions through a Single Submission Portal.

·        2021 (optional) TBC

·        Mandatory use 6 months after going live

 

 

·        To be decided as a part of network strategy

 

Delivered stepwise by CESSP-projects. CESSP is a programme to implement an online authoring tool for application forms and to enhance the current PDF based electronic application forms.

The first phase of this programme called “CESSP Phase 1” will deliver a new format for creation of Marketing Authorisation Applications with the goal to replace the relevant PDF forms with a web-based interface. This will cover both, human and veterinary application forms for new marketing authorisations and extension applications.

During the development project this system has been referred to as the CESSP but will be implemented within the current CESP as a new module.

To create and process the dataset an extension of CESP is being implemented and called “CESP Application Dataset Management Module (CESP Dataset Module)”.

For more information, please see the CESSP Q&A.

During the stepwise implementation of one Single Submission Portal, the integration of the current CESP and the EMA Gateway must be supported by a new service desk process that capture both current portals and the upcoming new portal solution.