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Human eSubmission
eCTD v3.2
eCTD EU M1 specification

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eSubmission expert group documents

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External Links

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Systems:

Common Repository

eAF

eASMF
ePMF
CESP

eSubmission Gateway & eSubmission Web Client

Delivery file UI

eSubmission Gateway

PAM submission form

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PSUR Repository

Industry access

NCA access
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Projects:

eCTD v4.0

CESSP

Paediatric submissions

SPOR

eSignatures

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Which forms can I digitally sign?

The Agency provides specific PDF certified electronic application forms to enable the Pharmaceutical industry to digitally sign and submit using a PDF Reader Application. Details of the available forms are listed below:

Paediatric forms

Request For Modification Of An Agreed Paediatric Investigation Plan:

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/09/WC500148544.pdf

Also available here:

Regulatory and procedural guidance page

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000266.jsp&mid=WC0b01ac05800b3789

Paediatric investigation plans, waivers and modifications page

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000293.jsp&mid=WC0b01ac0580025b91

Template letter for applicant - waiving rights for a re-examination request

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/09/WC500148547.pdf

Also available here:

Regulatory and procedural guidance page

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000266.jsp&mid=WC0b01ac05800b3789

Post-assessment guidance page

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000237.jsp&mid=WC0b01ac0580025ea7

Orphan medicines forms

Application for orphan medicinal product designation

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/09/WC500148542.pdf

Also available here:

How to apply for orphan designation page

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000519.jsp&mid=WC0b01ac05804ece5e

Orphans: Regulatory and procedural guidance and forms page

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000268.jsp&mid=WC0b01ac058061f01c

Common EMEA/FDA application form for orphan medicinal product designation

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/09/WC500148543.pdf

Also available here:

How to apply for orphan designation page

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000519.jsp&mid=WC0b01ac05804ece5e

Orphans: Regulatory and procedural guidance and forms page

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000268.jsp&mid=WC0b01ac058061f01c

Annual report on a designated medicinal product

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/09/WC500148541.pdf

Also available here:

Annual report on development page

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000343.jsp&mid=WC0b01ac058061f018

Orphans: Regulatory and procedural guidance and forms page

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000268.jsp&mid=WC0b01ac058061f01c

Transfer of sponsorship

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/09/WC500148546.pdf

Also available here:

Transfers of orphan designation page

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000340.jsp&mid=WC0b01ac058061f01a

Orphans: Regulatory and procedural guidance and forms page

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000268.jsp&mid=WC0b01ac058061f01c

Sponsor’s report on maintenance of the OMP designation at the time of MA

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/09/WC500148545.pdf

Also available here:

Marketing authorisation and market exclusivity page

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000392.jsp&mid=WC0b01ac058061f019

Orphans: Regulatory and procedural guidance and forms page

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000268.jsp&mid=WC0b01ac058061f01c

 

 

 


 

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