Danish agency updates guidelines on different submission formats

The Danish Medicines Agency has issued two guidances on the different formats companies can use to submit applications, in a bid to facilitate the submission of electronic applications and ease their timely evaluation^1-3.

The first guidance relates to the different application formats for marketing authorisation, variations, renewals, etc. The second guidance concerns paper-based applications⁴. Both guidelines – which came into effect on 29 July – replace previous guidance on submission formats, which became out dated in December 2010, when the DMA switched to full electronic processing of applications.

While the preferred format for human medicines submissions is eCTD (electronic common technical document), the guidelines clarify that the agency will still accept applications in the NeeS (non-eCTD electronic submission), VNeeS (for veterinary) and paper formats.

The updated guidelines clarify that the agency will no longer accept "mixed submissions", ie applications made both on paper and electronically. For such applications, the agency will assume that the paper version is also included in the electronic version. The DMA will, therefore, "dispose of the paper version without further processing" and will review the application as per the guidelines pertaining to electronic submissions.

The DMA clarifies that for both paper-based and electronic applications, it is sufficient to submit one copy. The agency is especially advising companies not to submit identical copies, "as we would have to allocate unnecessary resources to check if the documentation contains new information".

Also, until now, it was not possible for applicants to switch formats in the middle of a process. As a result, companies that were unable to submit all application types in electronic format were forced to make all submissions on paper. The DMA says that it will now be possible for companies to submit paper-based submissions for applications submitted in the NeeS/VNeeS format. This way, applicants will not be precluded from submitting paper-based applications by using the NeeS/VNeeS format. However, as before, the DMA will not accept switches from applications in eCTD format to other formats.

With regard to the submission of supplemental information, the DMA states that it will now accept supplemental information in NeeS or VNeeS format even it the first submission was on paper. The agency will also accept supplemental information in eCTD format, provided that the applicant commits to using the eCTD format for all subsequent submissions for the medicinal product in question.

Another new practice at the agency is that it will now accept supplemental information and working documents (draft summary of product characteristics, package leaflet and labelling) by email or via Eudralink. While documents will still be accepted in a CD/DVD, email or Eudralink is the preferred submission routes, the DMA says. For submissions by email or Eudralink, the documentation should:

• be supplemental information or working documents related to an application that was submitted previously by ordinary post;
• contain a clear and unambiguous reference to the case in the form of the DMA's 11-digit case number or EU procedure number;
• comply with the same format requirements as applicable to other electronic submissions;
• be compressed (zipped) in one single file;
• be sent to the email address: [email protected];
• be sent by email/Eudralink as the only submission route (submissions by both email/ Eudralink and CD will not be not accepted);
• for Eudralink: have a maximum expiry time (90 days).

If any of these criteria are not met, the document will be rejected without further processing, the guidelines state.

With regard to the identification of dossiers, the agency clarifies that it archives electronic applications according to the structure of the dossier as chosen by the applicant. The DMA wants each individual, technically valid submission in each dossier to be named uniquely. It adds that submissions affecting more than one dossier are to be archived in each affected dossier.

One dossier, it explains, usually covers the entire product family (all forms and strengths), "but it is up to the individual applicant to define the individual dossier". The agency is, therefore, encouraging companies to follow this structure consistently throughout the lifecycle of the medicinal product.

References

1. DMA, New guidelines on submittable formats for applications for marketing authorisation, variations, etc, 29 July 2011, http://laegemiddelstyrelsen.dk/en/topics/authorisation-and-supervision/licensing-of-medicines/news/new-guidelines-on-submittable-formats-fo--tions,-etc

2. Guidelines on submission of electronic applications, 29 July 2011, http://laegemiddelstyrelsen.dk/en/topics/authorisation-and-supervision/licensing-of-medicines/marketing-authorisation/application-for-marketing-authorisation/guidelines-on-submission-of-electronic-a--plications

3. Technical details for electronic applications, 29 July 2011, http://laegemiddelstyrelsen.dk/en/topics/authorisation-and-supervision/licensing-of-medicines/marketing-authorisation/application-for-marketing-authorisation/technical-details-for-electronic-applications

4. DMA, Guidelines on submission of paper applications, 29 July 2011, http://laegemiddelstyrelsen.dk/en/topics/authorisation-and-supervision/licensing-of-medicines/marketing-authorisation/application-for-marketing-authorisation/guidelines-on-submission-of-paper-applications