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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:
https://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/09/WC500148544.pdf
Also available here:
Regulatory and procedural guidance page
https://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
https://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
https://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/09/WC500148547.pdf
Also available here:
Regulatory and procedural guidance page
https://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000266.jsp&mid=WC0b01ac05800b3789
Post-assessment guidance page
https://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
https://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
https://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
https://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
https://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
https://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
https://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
https://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/09/WC500148541.pdf
Also available here:
Annual report on development page
https://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
https://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000268.jsp&mid=WC0b01ac058061f01c
Transfer of sponsorship
https://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/09/WC500148546.pdf
Also available here:
Transfers of orphan designation page
https://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
https://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
https://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
https://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
https://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000268.jsp&mid=WC0b01ac058061f01c
For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.
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