Submitting a post-authorisation application

HumanRegulatory and procedural guidance

From 1 January 2010, the electronic Common Technical Document (eCTD) is the only acceptable electronic format for all applications and all submission types in the context of the centralised procedure. This applies to all new and existing applications and all types of submissions to the European Medicines Agency (EMA).

These include new applications, supplementary information, variations, renewals, follow up measures (FUMs), periodic safety update reports (PSURs) for centralised authorised products, Notifications etc.

When submitting an application in eCTD, any Word document required for Module 1 (e.g. product information Annexes) and Module 2 should be located in the same eSubmission Gateway and eSubmission Web Client package within a folder called “xxxx­_working documents”, where the number (xxxx) equals the sequence number.

There is no obligation to submit a full, reformatted eCTD for already authorised products. However, if marketing authorisation holders wish, they may provide EMA with information reformatted as eCTD for their already authorised products. In particular, EMA would encourage the submission of reformatted quality information in eCTD, in order to facilitate the handling of variations and line extensions.

Replacement sequences of a previously submitted eCTD application (e.g. following corrections) are not acceptable. Instead, corrected eCTD applications should always be submitted as a new eCTD sequence. Replacements should always be accompanied by an updated cover letter explaining the reason of the re-submission. Upon validation, the final data package should be submitted to the Committee members only, in accordance with:

The submission of reformatted documentation (commonly referred to as a 'baseline' submission), should preferably occur simultaneously (but separately) with the submission of a variation, line extension or renewal. A clear distinction between the reformatted (unchanged) information and the documentation supporting the simultaneously submitted variation / line extension or renewal should be made.

An eCTD baseline submission is expected at day 0 of the application procedure, subsequent sequences should then be provided in accordance with the corresponding milestones for that procedure, through to approval. Please note that once the product starts an eCTD lifecycle, all subsequent submissions should follow this mandatory format.

Further details on implementation of the eCTD are provided on the EMA e-submission website, in particular:

References

How to submit the application

From 1 March 2014, the use of the eSubmission Gateway or Web Client is mandatory for all eCTD submissions through the centralised procedure. EMA no longer accepts submissions on CD or DVD. This applies to all applications for human medicines.

More information on how to register and connect to the Gateway / Web Client can be found in the eSubmission website and detailed information on the required naming conventions and file formats can be found in European Medicines Agency eSubmission Gateway: Questions and answers relating to practical and technical aspects of the implementation and the eSubmission Gateway web client: Guidance for applicants.

Applicants must follow the Dossier requirements for centrally authorised products and not send duplicate submissions electronically or via CD-ROM or DVD or via the Common European Submission Portal (CESP), as this might lead to delays in the handling of applications. For the submission of non-centrally authorised products or submissions in other than eCTD format, please refer to:

An automated acknowledgement email is sent from the system confirming whether the submission has passed the relevant technical validation criteria and whether it has been uploaded to the Agency's review tool and made available via the Common Repository. There is no need to Applicants must not send any accompanying hard media or separate paper cover letter as the cover letter will be in the relevant part of eCTD module 1 in PDF format.

Where applicable, revised product information Annexes (including Annex A, if applicable) should be included in electronic (Word and PDF) format in the same eSubmission Gateway / or eSubmission Web Client package within a folder called 'working documents'. Where applicable changes in Word documents should be indicated using 'Tools-Track Changes'. Clean PDF versions should have all changes 'accepted'

Submission to (Co-) Rapporteurs and other committee members

Submissions sent to EMA via eSubmission Gateway/Web Client will be considered delivered to all National Competent Authorities' representatives and alternates. This will apply to all types of Human Centralised Procedure eCTD submissions, including PMF submissions and ASMF submissions related to centrally authorised products submitted in eCTD format.

For the dossier requirements of the (Co-) Rapporteurs and other Committee members, including delivery addresses where applicable, please refer to the following document: Dossier requirements for centrally authorised products.

For the submission of non-Centrally Authorised Products or submissions in other than eCTD format, please refer to:

Dossier requirements for nationally authorised products (referral, PASS107, workshare, signal detection procedures) and ancillary medicinal substances in a medical device

For the particularities concerning applications under Worksharing and PSUR which may include nationally authorised products please check the information in the respective sections of the Post-authorisation Guidance.

Where applications are amended during the agency's review, such as e.g. responses to a request for supplementary information or a withdrawal, new or consolidated eCTD sequence should be provided in order to maintain the eCTD life-cycle. The same applies in case the outcome of the variation application review is unfavourable for one or more changes applied for (mixed outcome).

Please note that the EMA only accepts submissions made in eCTD format. Any exceptions to this rule can be found from the Dossier requirements for nationally authorised products (referral, PASS107, workshare, signal detection procedures) and ancillary medicinal substances in a medical device document.

Please also refer to the TIGes Harmonised Guidance for specific advice on eCTD Submissions.

For practical aspects of eCTD dossier submission under the Variation Regulation (EC) No 1234/2008, please refer to the 'Q&A - eCTD Variations' published on the Agency e-submission website.

The use of the electronic Application Forms (eAFs) in the Centralised Procedure is mandatory as of 1 July 2015. Information on the electronic Application Form can be found in the eSubmissions eAF webpage.

When submitting applications the MAH should observe the recommended submission dates published on the agency website (see 'submission deadlines and full procedural timetables').

References

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