Guidelines on submission of paper applications
In connection with the application for a marketing authorisation, variation, update prior to MRP, renewal, follow-up and referral to CMD, companies can submit the application and supplemental information on paper or electronically. Please find below the Danish Medicines Agency's guidelines on submission of paper applications and supplemental information. The guidelines also apply to Active Substance Master Files (ASMFs) submitted by the applicant and ASMF holder.
The guidelines complement the guidelines issued by the EMA and CMD and apply to applications submitted under the national procedure (NP), mutual recognition procedure (MRP) and the decentralised procedure (DCP). With regard to applications under the centralised procedure, we refer to the guidelines on the EMA website.
We consider a submission to be paper-based if it includes paper documents only. An application is considered a paper-based application if the first submission is paper-based.
The Danish Medicines Agency's internal workflow processes are fully electronic. After we have verified the signature, we therefore convert all paper-based applications to electronic format by scanning the documents and processing them through OCR. We encourage applicants to switch to electronic applications to the extent possible, as it eases our internal workflow processes considerably. See "Guidelines on submission of electronic applications".
In this context, we distinguish between "applications" and "submissions" in that one application consists of one or several submissions:
- First submission on a regulatory activity means the approach commencing a marketing authorisation application, variation, commitment, follow-up measure, referral to CMD or similar regulatory activity. The format of the first submission determines the format of the application.
- Supplemental information means a submission supplementing or correcting previously submitted documents under the same regulatory activity. This also applies to response to LoQ, etc.
- Working documents means draft versions of summary of product characteristics, package leaflet, and labelling editable by the Danish Medicines Agency.
We only accept submissions that are either fully electronic (see "Guidelines on submission of electronic applications") or fully on paper. However, working documents must always be submitted electronically (see below).
Unless, it explicitly appears from the cover letter and imprint on CDs/DVDs that the submission concerns working documents only, we will assume an enclosed CD/DVD to contain all submitted documentation. We then regard the submission to be electronic, and any documents on paper, aside from the cover letter and (if applicable) the 'Confirmation for eCTD submissions' will be disposed of without further processing.
The applicant can submit supplemental information electronically (in NeeS format) even though the first submission was in paper. We do not consider this as a mixed submission. However, please see the "Guidelines on submission of electronic applications" as well as the sections "Format switch" and "Format requirements" below.
If an applicant has switched to eCTD submission, subsequent paper submissions are not accepted for the medicinal product in question. See "Guidelines on submission of electronic applications".
The first submission for a paper-based application must be on paper. Paper submissions must conform to CTD for human applications and NtA for veterinary applications.
It must appear clearly from the cover letter that the submission is paper-based, that the documentation on the enclosed CD, if any, is identical with the paper documents and that the documentation on the CD is neither in NeeS format nor eCTD format. Only CDs/DVDs are accepted as submission media together with the paper version. The Danish Medicines Agency reserves the right to choose which version to use. Submission of an electronic version is not a requirement, but would be a great help for us. If you submit an electronic version in addition to a paper application, the application will be processed as a paper submission.
Since we wish to receive documentation electronically to the greatest extent possible, we will accept the electronic submission of supplemental information during a procedure whose first submission was on paper. Such an electronic submission must conform to the NeeS standard for human applications and the VNeeS standard for veterinary applications (see the "Guidelines on submission of electronic applications"), and will be technically validated as such. It must clearly appear from an email or cover letter that the submission concerns supplemental information related to a paper-based application.
Working documents must be submitted to us in an electronic and editable format. The documents must be in MS Word format and must have a meaningful file name. It must clearly appear from the cover letter and imprint on the CD or from the email that the submission concerns working documents only. Furthermore, it must clearly appear which case the working documents concern, as the Danish Medicines Agency's case number and/or corresponding unambiguous case reference must appear from the email's subject heading or cover letter.
Paper submissions must be sent by ordinary post or courier to the Danish Medicines Agency's postal address. Documents submitted by fax, or similar media, will not be accepted as documentation on paper. The documents must be one-sided copies on A4 paper and must be packed in ring binders or similar holders so as to facilitate the scanning of documents. Tab dividers that deviate significantly from the A4 format should be avoided. We urge you not to use paper clips and staples. Also, we advise applicants that the use of colours and grey tone for illustrations, etc. may not be depicted clearly after scanning the documents.
Supplemental information in electronic format is to be submitted as described in the "Guidelines on submission of electronic applications".
Working documents should generally be submitted by email or via Eudralink to firstname.lastname@example.org. However, working documents can also be submitted on CD/DVD if it is clearly stated in the cover letter and it appears from the imprint/label of the CD/DVD that the submission concerns working documents only. The requirements imposed on the submission of working documents are the same as described in "Guidelines on submission of electronic applications".
It is crucial that applicants do not submit the same documentation in parallel via different routes (e.g. in paper form and on CD or in paper form and by email) as this would require unnecessary resources to handle and compare documentation with already received versions.
Number of copies
It applies to both paper-based submissions and electronic submissions for paper-based applications that it is fully sufficient to submit one copy or one CD/DVD, regardless of the type of application or the procedure type (NP/MRP/DCP).
The Danish Medicines Agency reserves the right to request additional copies during the review phase, if, by exception, this should prove necessary.
Paper submissions must bear an original wet signature on the cover letter and application form. Supplemental information submitted electronically is to comply with the guidelines on electronic applications.