The electronic format is the expected format for submissions today and to be able to work more efficiently, the Medical Products Agency (MPA) really urge applicants to send all their submissions in electronic format (eCTD, NeeS or VNeeS).
If an application is made in an electronic format, subsequent submissions for that product (including all strengths and forms) are expected in the same format (unless upgraded from NeeS to eCTD).
An electronic application must fulfil the current ICH- and EU specifications (eCTD) as well as the TIGes harmonised EU guidelines (eCTD, NeeS and VNeeS) (see links to ICH and TIGes websites on right).
There is also a specific guide for the practical handling of applications in eCTD format within MRP and DCP: ’CMDh Best Practice guide on the use of eCTD in the MRP/DCP’ (see link on right).
Please note that national translations should be sent outside the eCTD structure (as “working documents” with the eCTD sequence where relevant).
Pure national submissions like MAH transfers do not need to be submitted as eCTD sequences to the MPA. However, any submitted PDF files (e.g. mock-ups) should always be provided in PDF version 1.4, 1.5, 1.6 or 1.7.
How to submit an application
There are three ways to submit an electronic application to the MPA;
- By the CESP (This is the preferred way of submissions)
- By email/EudraLink (Can be used for smaller submissions, max 20 MB via email, max 80 MB via EudraLink. Use zip for eCTD, NeeS and VNeeS.)
- By CD/DVD
Please, do only use one of these ways for a submission.
Neither original signatures nor scanned signatures are needed on the application form or the cover letter.
PDF files should normally, wherever possible, be created from electronically written documents. In order to facilitate the assessment work, please make sure that your PDF files when copied into MS Word documents (our assessment reports) result in fully editable formats.
Always attach MS Word copies (with “tracked changes” if relevant) of the Product Information (SmPC, PL and labelling). MS Word copies are also helpful for Module 2 documents for submissions within the national procedure or when Sweden is the RMS in DCP/MRP to further facilitate copying of text and tables into the assessment reports.
The word files are only working copies and should be placed outside the electronic submission structure in a separate ”working documents” folder.
We recommend the use of the cover letter template published by the CMD(h) for applications within MRP/DCP (see the link on the right to the HMA’s website). The template is also recommended for national submissions to the MPA.
When using the CESP
From 12 November, the new, improved, Common European Submission Platform, CESP, can be used for MRP, DCP and national electronic submissions. This makes submission fast, safe and easy and the MPA encourages all applicants to use this portal for submissions. No CD/DVDs should be submitted to the MPA for submissions sent through the CESP. As for other electronic submissions to the MPA, only eCTD, NeeS and VNeeS formats are accepted. The CESP should not be used for electronic copies to paper dossiers.
The CESP can be accessed via a specific HMA CESP website (see link on right). To use CESP, registration should be done at this website. A “self-service model for user management” is employed. This means that every company must appoint its own “company administrator”, who establishes and maintains the access to CESP for employees of that company. To initiate the registration of the “company administrator”, a form must be completed using the Registration link on the new website.
This website also contains a lot of other information (e.g. FAQs and training videos) and you can also register for an online training session to get more knowledge. (Also, see some information further down on this page.)
When using EudraLink, please set the expiry date to at least 30 days.
If the submission is sent via e-mail/EudraLink, it should not also be sent by CD/DVD. If that for some reason is needed anyway (e.g. for publishing of eCTD sequences), a notification should be attached to the CD to clarify that the same documentation has already been sent by e-mail, and that it is now beeing re-sent in another format.
When using CD/DVDs only one set of discs per submission should be sent to the MPA. Each submitted CD/DVD should be clearly labelled in accordance with current EU guidelines for electronic submissions. If several submissions (regulatory activities) are submitted at the same time for the same medical products, these should be combined on the same CD/DVD, but each submission should have a unique folder structure on the CD/DVD and the disc should be clearly labelled with all included submissions.
A paper copy of the cover letter should be attached for quick identification, but no signature is needed.
More information regarding practical administration of submissions can be found in “Practical guidance for submission of applications” (see link on right).
Transition from paper to electronic format
The MPA encourages applicants to submit electronically also for products with paper dossiers.
The switch to eCTD, NeeS or VNeeS should be done in connection to the start of a new regulatory activity or by sending a so called baseline submission (see below). To clarify and facilitate the switch, the specific form ”Confirmation for electronic-only submission” (see link on right) should be filled in and attached to the paper cover letter sent with the submission that initiate the switch. The form does not have to be included electronically on the CD/DVD.
The reason for the confirmation is that the MPA have a strong preference for having all strengths and forms of the same trade name handled in the same format in the document management system.
Since only the EU standard formats are accepted by the MPA, we will carry out a technical validation of the submission. If the submission is technically invalid, the MPA will require a corrected submission to re-validate. When the application is found technically valid, this will be confirmed and the MPA consider the dossier as an electronic dossier (all strengths and forms of that trade name) for future submissions.
Product documentation previously submitted in paper format (current dossier) does not have to be submitted again in electronic format. However, the MPA recommends that applicants converting to eCTD format should reformat module 3 as a current baseline dossier and submit it as a separate sequence (preferably the first eCTD sequence, e.g. 0000). In the cover letter of such a baseline submission, the applicant should confirm that only the format of the dossier has changed, not its content.
More information on baseline submissions can be found in TIGes EU Harmonised eCTD guidance (see link to TIGes website on right).
Transitions in connection with MRP or Repeat Use
If the applicant wishes to switch to an electronic format in connection with Sweden acting as RMS in an MRP or Repeat Use-procedure, the electronic dossier planned for sending to the CMSs should first be sent to the MPA well before the start of the procedure. This is in order for the MPA to have time to complete a technical validation and inform the applicant of the outcome and allow time for correcting any mistakes. Applicants are welcome to contact the MPA to discuss these kinds of submissions, and are also referred to the guidelines on the CMD(h)’s website: ‘CMDh Best Practice guide on the use of eCTD in the MRP/DCP’ (See link to the HMA website on right).
The MPA performs technical validation of all electronic submissions with the current TIGes EU technical validation criteria. We test for all Pass/Fail criteria by using the EURS validator (Extedo). The software can be downloaded free of charge from the company website (see link on right).
For new applications in eCTD format in DCP, the MPA strongly recommends the applicant to use the “RMS technical validation pilot procedure” (see link to the HMA website on right). Don’t forget to include the information in the cover letter as described in the workflow for the pilot. In these cases the application submitted to the MPA for validation must, of course, exactly correspond to the application to be submitted to the other countries.
From 1 December 2012, the new version of the TIGes EU technical validation criteria will be used.
Submissions in paper format will continue to be accepted by the MPA, even if electronic format (eCTD, NeeS or VNeeS) is strongly recommended. Only one full paper copy should be submitted and some form of electronic copy of the paper submission should be attached to facilitate the assessment. This electronic submission would only be regarded as a copy of the paper version. Applicants are expected to make a transition to electronic format as soon as possible for all products based on paper dossiers.
Active Substance Master File (ASMF)
The MPA also prefers electronic submissions (eCTD, NeeS or VNeeS) for the ASMF documentation submitted from ASMF holders. The same format requirements as for medical products apply (see above). If submitted on CD/DVD, a paper copy of the cover letter should be attached for quick identification, but no signature is needed.
The submission will be technically validated and if the technical requirements are not met a corrected submission will be requested. When the electronic format is accepted by the MPA the ASMF holder will be informed and afterwards all future submissions for that ASMF dossier are expected to be submitted in electronic format only.
In accordance with current EU guidelines, the format of ASMF documentation does not have to be the same as the format used for the medical products referring to the ASMF. However, the documents in the open part should of course fully correspond in content regardless of format.
For more information on how ASMF documentation should be handled in eCTD format please refer to the document “Practical Guidelines on the Use of the eCTD Format for ASMFs for Active Substance Master File Holders and Marketing Authorisation Holders” which can be found under “Documentation” on the EMA’s eSubmission website (see link on right). This guide is also useful as a basis for making an ASMF submission in NeeS format.
Transition from old CESP to improved CESP
Perhaps you have already been using the earlier version of CESP “PoC”. This older CESP environment of CESP will now be inactive and you must re-register for the new improved version in connection to when the new “self-service model” is taken into use.
Please address any questions about registration, technical details regarding setting up the connections or the transfer from the old CESP to the improved version to the support given at the new CESP webpage (see link on right).
History of CESP
The Common European Submission Platform (CESP) is an initiative of a group of EU member states and industry representatives, managed by the Heads of Medicines Agencies (HMA). The aim of the CESP is to examine whether it is possible to establish an electronic platform to which applications and deviations in the national procedure, MRP and DCP for both human and veterinary medicinal products can be sent.
In October 2011 a Proof of Concept (PoC) was set up to test this. Given the success of this PoC, the next steps were approved by the HMA in November 2011. Two subgroups were established to create a structure for the ‘governance’ and financing of the CESP as well as to further develop the technical platform. The technical group is responsible for the further development and establishment of an ‘extended PoC’. This ‘extended PoC’, to which ‘real-life’ applications and deviations could be sent, was also successful. The ‘extended PoC’ will now be transformed into a ‘pre-production pilot’ in October. In the coming months the pilot will be moulded further into a complete production environment for the CESP.