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Esubmissions Requirements New Applications 1

The document provides requirements for electronic submissions for new marketing authorization applications within the Mutual Recognition Procedure, Decentralized Procedure, and national procedures. It outlines that electronic submissions are recommended in eCTD format but the Non-eCTD format is also accepted. A table is included that lists the number of electronic copies required by each national competent authority, noting some authorities still require some paper modules as well. Guidance is provided on acceptable formats for product information and response documents.

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Rambabu komati - QA
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159 views2 pages

Esubmissions Requirements New Applications 1

The document provides requirements for electronic submissions for new marketing authorization applications within the Mutual Recognition Procedure, Decentralized Procedure, and national procedures. It outlines that electronic submissions are recommended in eCTD format but the Non-eCTD format is also accepted. A table is included that lists the number of electronic copies required by each national competent authority, noting some authorities still require some paper modules as well. Guidance is provided on acceptable formats for product information and response documents.

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Rambabu komati - QA
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© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
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Requirements on Electronic submissions for New Applications

within MRP, DCP or National procedures


Final, February 2008
The table below refers to number of electronic copies requested by each National Competent Authority for new applications for approval for Marketing Authorisation.
If for some reason the requirements cannot be fulfilled, the applicant should contact the relevant NCA before submission.

Website addresses to each National Competent Authority can be found at the Heads of Medicines Agencies website (www.hma.eu) and in Notice to Application volume 2A chapter 7.
Relevant e-mail addresses for electronic response documents in MRP and DCP can also be found at the Heads of Medicines Agencies website (www.hma.eu – CMD(h) – Contact points).

For all electronic submissions, the eCTD format is highly recommended. However, in general, the Non-eCTD electronic submission format (NeeS) is also accepted.
Please, refer to the Notice to Application volume 2B for the eCTD specifications and otherwise to the document “Guidance for Industry on Providing Regulatory Information in Electronic Format: Non-eCTD electronic
Submissions (NeeS)” – to be endorsed and published by the EU Telematic Implementation Group for electronic submissions (TIGes) at the EMEA website (http://www.emea.europa.eu/).
Please, also seek advice at different NCA’s websites if specific format requirements are stated by footnotes in the table below.

The electronic submission should be provided on CD (or preferably on DVD if not fitted into one CD) unless otherwise stated by the use of footnotes in the table below.
The application form and cover letter should always be submitted in signed paper original, unless otherwise stated by the use of footnotes in the table below.

The Product Information should always be in QRD/CMD(h) template, (see the CMD(h) Annotated QRD template for MR/DC procedures at the Heads of Medicines Agencies website (http://www.hma.eu/22.html).
Response documents submitted during the MR/DC procedure should comply with the CMD(h) recommendations “Applicant’s response document in MR and DC Procedures Recommended CTD Format” see
http://www.hma.eu/uploads/media/response_ctd.pdf and for eCTDs also with the EU Module 1 Specification V1.2.1 (see http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev2.htm#2b).

Table 1. Electronic submission strongly recommended instead of paper or with only some modules additionally in paper (Number of electronic copies asked for)*

Documentation AT BE BG CY CZ DK DE EE EL ES FI FR HU IE IT LV LT LU MT NL PL PT RO SE SK SI UK IS NO
Module 1-5 electronic only 8 8,9,11
- 1 - - - - - - - - - - - - - - - - - 1 - - - - - - 1 - -
(No additional paper)
Module 1-5 electronic with
- - - - - - - - - - - - - - - - - 1 - - - 410 - - 24,8 14,7 - 1 -
additional paper for Module 1*
Module 1-5 electronic with
1 - - - - - - - 1 - - - 17,8 - - 14,6 16 - 26 - - - 73,6,7 - - - - - 18
additional paper for Module 1-2*
Module 1 -5 electronic with
- - - 1 16,12 - - - - - - - - - - - - - - - - - - - - 1 - - -
additional paper for Module 1-3*
Response Documents electronic
1 1 - - - - - 16 11 - - - 17,8 - - 16 - - 16 11,8 - 410 63 - - - 1 1 -
only (No additional paper)

Table 2. Electronic submission strongly recommended together with the required paper original (Number of electronic copies asked for)*

Documentation AT BE BG CY CZ DK DE EE EL ES FI FR HU IE IT LV LT LU MT NL PL PT RO SE SK SI UK IS NO
Electronic copy of Module 1-5* - - 1 - 15 3 2 1 - - 2 5 - 1 18 15 15 - 25 - 43 - 13,5,7 1 - - - - -
Electronic copy of Product
- - - - 1 1 12,8 1 1 - 1 5 - 1 - - - - 1 - 13 - 15 1 - - - 1 -
Information in word format
Electronic copy of Module 2 in
- - - - - - - - 1 - - 26/45 - - - - - - - - - - - 1 - - - - -
word format
Electronic copy of Response
- - 1 1 - 11 22 15 - - 11 22 - - - 15 - - 15 - 43 - 15 1 - - - 1 -
Documents

*For numbers of paper copies requested, please refer to Notice to Application volume 2A chapter 7, section 3.1. Please note that some NCAs may require a reduced number of paper copies if electronic copies are provided.

1) Should only be sent by e-mail/EudraLink


2) Should additionally be sent by e-mail/EudraLink
3) DVD is not accepted
4) A paper copy should be available on request within 14 days
5) For national applications and applications where the member state acts as RMS
6) For applications where the member state acts as CMS
7) Additional signed paper original in accordance with National requirements stated in NtA volume 2A Chapter 7
8) For specific format requirements on the electronic submission, see NCA’s website
9) The application form and the cover letter are not required in paper format.
10) The application form is not required in paper format
11) Applications should be made through the NCA’s website or portal
12) A signed commitment should be provided stating that a paper copy of specified parts of Modules 4 and/or 5 should be submitted within 48 hours upon request and, if necessary, a full paper version of Modules 4 and/or 5 within 1 week.

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