Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH www.basg.gv.at

DI Georg Neuwirther Head of IT AGES MEA

AGES-Gespräch PHV

Vienna, 15.9.2016

Update on PSUR repository

operational aspects

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Agenda

• Update

- eCTD

- Creation tool

- Tipps

• Live demo

- Tipps

- Create delivery file for PSUSAs

- Create delivery file for PSUR

• EMA Helpdesk

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• NeeS AND eCTD are accepted formats for PSUR-repository submissions.

For eCTD:

Specification for eCTD EU M1 v3.0 was entered into force on 1 July 2016.

The changes related to the use of ‘submission type’ and the new ‘submission unit’ have been introduced to the PSUR repository in the release v1.07 of the PSUR Repository which was made available on 22 July 2016.

Submissions created using eCTD EU M1 specification v2.0 can be submitted in line with the EU M1 v3.0 specification as implemented in the PSUR Repository. The use of the EU M1 v3.0 and v3.0.1 will be mandatory from 1 October 2016.

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eCTD - update „Update eCTD EU Module 1 Specification“ - timelines

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eCTD - update „Update eCTD EU Module 1 Specification“ - attributes

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According to “eCTD EU Module 1 Specification”

• The existing attribute of the “submission type” will then solely

describe a regulatory activity.

• The “submission unit” will describe actions within that regulatory

activity like

- an initial submission of an application

- an update due to validation issues, responses to questions from

agencies, any supplemental information or consolidating

submissions after closing a regulatory activity.

- In the same way “reformat” will be used as a submission unit

together with submission type “none” as it is not a regulatory

activity, but just a reformatting of the dossier.

DI Georg Neuwirther

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eCTD - update Submission Types for PSUSA-PSURs

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Please be careful when selecting the submission type in the

eCTD envelope

eCTD submission type=

• “psur” = Periodic Safety Update Report (PSUR) which should only be

used for PSURs outside of the PSUSA

• “psusa” = PSUR single assessment procedure

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eCTD - update Submission Unit /1

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eCTD - update Submission Unit /2

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eCTD - update eCTD - UUID

• To support automation of processing at all agencies a new attribute containing a Universal Unique Identifier (UUID) was added. This UUID should be generated when the first sequence using the revised specification version 3.0 or 3.0.1 is published.

• This UUID will be kept as a reference for all subsequent submissions related to the application (also known as dossier).

• UUIDs are formally defined by ISO/IEC 11578:1996 and ITU-T Rec X.667 | ISO/IEC 9834-8:2005. UUIDs are represented as follows:

• String of digits separated by hyphens: e.g. 25635f23-a3a4-4ce0-9994-99c5f074960f 596

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DI Georg Neuwirther

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eCTD – impacts on the „Creation Tool“

• Regulatory activity ‘Supplementary Information’ replaced by the use of combination of ‘submission type’ and ‘submission unit’ as per the updated EU M1 Specification.

- After submissions of the ‘initial’ PSUSA or PSUR submission for which a positive acknowledgement has been received the submission type remains “PSUSA/PSUR” and the relevant submission unit should be selected, for example responses, additional information etc.

• Creation of delivery file for any subsequent sequences (responses, additional information etc) after the initial PSUR submission is not linked to a submission deadline thus no late submission ID is required.

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PSUR repository – News How to avoid submission problems

• Only one package and delivery file should be included per zip file

• Place the “xml delivery file” in the root level of the folder structure and ensure that the structure is not superfluous i.e. it should not contain additional empty folders on top level.

Source: EMA PSUR Guidance

• You can rename the zip file according to Annex 3 filenaming examples if you wish to do so. The zip package filename is not checked by the system.

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PSUR repository – News How to avoid submission problems

• Do not add NeeS submissions inside eCTD zip file and vice versa

• Always use the “Advanced Mode” for all transmissions via the Web Client, also for submissions smaller than 10MB to receive the receipts and acknowledgements from the eSubmission Gateway / Web Client

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Live Demo

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Essentials / 1

• Submissions have to be split into separate submissions based on format and lifecycle of related products:

• Do not mix different submission formats

• Do not mix different sequence numbers

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Essentials / 2 http://esubmission.ema.europa.eu/psur/docs/PSUR%20Repository%20user%20guide%20for%20MAH%20submissions.pdf

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EU Single assessment e.g. PSUSA/00000224/201607

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PSUR example

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PSUR: Deduplication

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Source:

http://esubmission.ema.europa.eu/psur/docs/PSUR%20Repository%20user%20guide%20for%20MAH%20submissions.pdf

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EU-single assessment Deduplication

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Use grouping to inform regulatory bodies that submissions belong together

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EMA Helpdesk

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Maintenance

• If the PSUR-repository not available please check website:

- http://esubmission.ema.europa.eu/psur/psur_repository.html

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EMA Helpdesk

• All technical or usability queries should be sent to EMA via the EMA helpdesk tool https://servicedesk.ema.europa.eu

- no Emails

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EMA Helpdesk

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EMA Helpdesk

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