1. Introduction

It was agreed by the Heads of Medicines Agencies (HMA) in Reykjavik on 28 February 2005 that by the end of 2009 each of the European Registration Agencies would be ready to accept documents attached to the applications for registration, submitted in electronic format (e-submission). Complying with the said provisions, the Office hereby announces that, as of 1 January 2010, it will accept documents submitted in electronic format (NeeS, eCTD), provided the application and any of the documents mentioned in Tables 1, 2 and 3 in the Annex hereto must be submitted in paper, niezależnie od złożenia ich w formie elektronicznej.

With a view to making the medicinal products registration process more efficient, as well as bearing in mind special care for the natural environment, and an array of other advantages resulting from the substitution of paper documents with their electronic counterparts, the Office highly recommends that the documents required be submitted in either of the accepted electronic formats eCTD or NeeS. The Office further states that our ultimate objective is to entirely substitute both paper format and electronic NeeS format with the eCTD standard. The date of the eCTD standard being accepted as the only format will be specified at a later date, and will depend on the Marketing Authorization Holders readiness to work in the new standard.
The eCTD format is not mandatory. Any documents submitted on paper will still be accepted by the Office. The choice of format remains within the discretion of the applicant.

2. Format dokumentacji elektronicznej

eCTD is an electronic version of the Common Technical Document, extended by Module 1. The structure, as well as the file and folder names, reflect the CTD standard. What makes it different is the technical component XML, enabling the supervision and management of the entire product life cycle.
The structure and organisation of the eCTD documentation were defined on the basis of the following standards:

• ICH M2 eCTD Specification
• EU Module 1 Specification
• ICH and European Commission Guidance

NeeS is a set of documents in electronic format, developed by the Marketing Authorization Holder, based on the Common Technical Document (CTD) definitions, differing from the eCTD format in its lack of the Extensible Mark-up Language (XML) technical components.

The description of definitions, the guidance and guidelines concerning both application formats, were included in the following documents:
1. Guidance for Industry on Providing Regulatory Information in Electronic Format: eCTD electronic Submission, Version: 1.0, May 2009
2. Guidance for Industry on Providing Regulatory Information in Electronic Format: Non-eCTD electronic Submission (NeeS), Version: 1.4, January 2008
3. The EMEA website on the eSubmission project - http://esubmission.emea.europa.eu
4. The ICH Organisation website - http://ich.org, http://estri.ich.org
5. The European Commission website - http://ec.europa.eu
6. Volume 2B Notice to Applicants - Presentation and format of the dossier Common Tehcnical Documentation
7. Requirements on electronic submissions for New Applications within MRP, DCP or National procedures http://www.hma.eu/277.html

3. Application types which may be supplemented with documents in electronic format

As of 1 January 2010, the Office will accept documents concerning human medicinal products submitted in electronic format, including:

• New Applications
• Renewal Applications
• Variation Application
• Reriodic Safety Update Reports (PSUR)
• ASMF documentation

in all types of procedures, i.e. national, MRP, and DCP.

4. Documents required in paper format

Irrespective of the procedure type, the Office requires submission of the original paper version of the documents mentioned in:

• Table 1 - marketing authorisation
• Table 2 - renewal
• Table 3 - variation

Please note that the documents included in the tables form part of eCTD documentation. Should the submission period of the relevant eCTD sequence be insufficient, for instance at the application validation stage, or upon completion of the decentralised procedure, the Office may accept as a substitute documentation provided either in NeeS format or in paper format, until the relevant eCTD sequence is submitted.

Please note that any application must each time be supplemented with a covering letter providing an exact description of the content, as well as of the previously submitted sequences, which will considerably accelerate its processing. We suggest familiarisation with the covering letter template recommended by CMDh: http://www.hma.eu/219.html.

5. Turning from paper or NeeS format into eCTD format

The submission of documents in electronic format may take place at any stage of the product life cycle, i.e. upon submission of the application for marketing authorisation of a medicinal product, upon renewal or upon variation.

However, it should be noted that once the procedure has been initiated, the format change into eCTD may not take place. Therefore, no supplements in eCTD format will be admitted if the application for marketing authorisation of a medicinal product has been submitted in any other format.

Should the Marketing Authorization Holder decide to turn from paper or Nees format into eCTD format upon submitting renewal, or for post-registration variation, it should additionally submit the documentation reformatted into eCTD (�technical baseline�), together with the statement that the said modification referred to the format, and not to the content. The �technical baseline� application should be numbered as �0000.�

6. The file format accepted by the Office for Registration of Medicinal Products

The majority of documents forming part of the documentation submitted in electronic format should be in PDF format, Version 1.4. They should be based on the electronic source documents, and not on scans of the paper version (except where either the access to the electronic source version is impossible or the signature on the document is required).
In specific cases, the documents may be annexed in other formats (e.g. RTF or MS Word file formats), together with a copy in PDF.

7. Media

Currently, documentation in electronic format should be submitted on a CD or DVD. In specific cases, and at the request of the responsible entity, the Office may consider the use of data carriers other than the aforementioned.
No data encryption or compression is admissible.

8. Media label information

Special attention should be label information, which must be precise and compliant with the requirements below.
Any CD and/or other carrier served upon the Office should contain the following information:

• Format (NeeS or eCTD)
• Name of the Marketing Authorization Holder
• Name of the medicinal product
• Name of the active substance
• Procedure number (where applicable)
• Sequence number (for eCTD applications only)
• Number of carriers covered within the application
• Application type
• Contact e-mail in case of any carrier-related problems

9. Technical validation

Technical validation checks the submission format, structure, file and folder naming convention included in the CTD standard. It is carried out regardless of the kind of application submitted. In the case of a negative technical validation it will be necessary to resubmit the sequence number "0000".

The criteria for the technical validation of particular formats have been stated in the following documents:

• eCTD validation criteria v2.1 - for applications in eCTD format
• NeeS Validation Criteria v1.0 - for applications in NeeS format

The Office encourages Marketing Authorization Holders, before filing an electronic application in NeeS format, to carry out technical validation with the use of NeeS Checker software, provided by the FAMHP Agency, Belgium, available on http://www.fagg-afmps.be.

10. Additional information

Documentation submitted to the Office in electronic format should have been previously checked against viruses using current antivirus software. The CD should be supplied with a statement confirming this check and information on the name and version of the program used. After receiving the application, the Office will carry out further verification with regard to the presence of viruses.

Any comments or questions should be sent to the following e-mail address:
ectd /at/ urpl /dot/ gov /dot/ pl