Iceland Drug Product Registration

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