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Format requirements for applications for authorisation of medicinal products: eSubmission Roadmap

13 July 2015, Updated 12 April 2018

Submission of applications for marketing authorisation is being developed, which will imply changes to the requirements of DKMA and the other European drug regulatory authorities in the coming years regarding the format and submission of applications.

The European national drug regulatory authorities and the European Medicines Agency (EMA) have issued the document ”eSubmission Roadmap” and have shaken hands on introducing a number of initiatives to ensure progress towards more electronic and automated case processing to the benefit of both the authorities and industry.

You can find the document here: eSubmission Roadmap

eSubmission Roadmap is not a final document, but the authorities' present proposal for long-term objectives and a plan for how to implement them.

The document concerns submissions from industry to the authorities related to marketing authorisations for medicinal products: applications for marketing authorisations, variations, update prior to MRP, renewal, follow-up, referral to CMD and PSUR. The document also applies to Active Substance Master Files (ASMFs). By default, the document does not apply to parallel import or parallel distribution.

The document concerns human and veterinary applications and applies to applications under the common European procedures – the centralised procedure (CP), the decentralised procedure (DCP) and the mutual recognition procedure (MRP) – as well as the purely national procedure (NP).

Long-term objectives

We would like to highlight the following long-term eSubmission Roadmap objectives:

  • eCTD is the mandatory format for applications of medicinal products for human use
  • VNeeS is the mandatory format for applications of medicinal products for veterinary use
  • Establishment of single EU eSubmission portal for submissions to all authorities – regardless of procedure
  • Implementation of electronic application forms (eAF)
  • Submission of paper applications to be eliminated
  • The use of physical media (e.g. CD) to be eliminated
  • Implementation of common repository for applicants' submissions – regardless of procedures

Milestones

The eSubmission Roadmap lists a number of milestones towards achieving the common objectives. We will concentrate our efforts on the milestones listed in the document.

The individual member states plan the elimination of paper applications. Paper applications demand considerable resources at DKMA. Consequently, elimination of NeeS has no value if paper is the the chosen format. For that reason, we encourage industry to combine the elimination of paper applications with the phasing-out of NeeS.

We would like to highlight the following milestones:

Time
Objective  Case types
Procedure(s)  Domaine(s) 
(01-2010)
eCTD mandatory in CP (all)
CP
Human
(07-2015)
eCTD mandatory in DCP
New (1)
DCP
Human
(07-2015)
eAF mandatory in CP
(all)  CP
Hum. + Vet.
(07-2015)
Common Repository mandatory for NCAs
(all)
CP
Human
(01-2016)
VNeeS mandatory in new CP and DCP
New (1)
CP + DCP
Vet. (2)
(01-2016)
eAF mandatory in all cases
(all)
DCP + MRP + NP
Hum. + Vet.
(06-2016)
PSUR Repository mandatory for NCAs
PSUR

Human
(01-2017) eCTD mandatory in all new MRP cases New (1) MRP Human
(01-2017) VNeeS mandatory in CP/DCP/MRP (all) CP + MRP Vet. (2)
01-01-2018 eCTD mandatory in CP/DCP/MRP (all) MRP Human
01-07-2018 eCTD mandatory in all new cases New (1)  NP Human
01-07-2018 VNeeS mandatory in all new cases New (1) NP Vet. (2)
01-01-2019 eCTD mandatory in all cases (all) NP Human
01-01-2019 VNeeS mandatory in all cases (all) NP Vet. (2)

(1) New cases mean an application for a new marketing authorisation; the documentation is structured from the beginning. For MRP, shift from NP to MRP, Repeat Use Procedure (RUP) as well as the previous assessment report update.

(2) Note that VNeeS has always been the only acceptable format for electronic-only applications to the Danish Medicines Agency in the veterinary domain.

External links

EMA eSubmission Roadmap

Report from CMDh, January 2015, see ”Electronic submissions” (at the bottom of page 1)

EU Electronic Application Forms

EMA eSubmission

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