It is composed of a set of submission steps, simulating a real case. Some of the files are “real” files with anonymized content; most of the files are “dummy” files with only the section name and the version number. This was done in purpose to allow easy download of the pilot.
Product information is as follows
You can download a zip file (warning: 16MB) for local use.
Alternatively, the following examples run online (please note there are occasional issues with links that do not work which we are trying to fix - if that happens please use the Back button):
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Scenario No. |
Scenario Description |
Link |
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0000 |
Full submission of Efpiate |
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0001 |
Submit response to questions Cover page is provided in Module 1 Answers to questions are provided in a node extension 1.7.4 with additional supporting files |
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0005 |
Submit addition of a new plant The new plant is producing the Efpiate in exactly the same way than another existing plant; it is considered as a Variation Type 1 with no change in the Summary Section (/module 2) |
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0006 |
Submission of a PSUR, which is provided as in 5.3.6 (Reports of post marketing experience). As this is the first time the PSUR is submitted the file is indicated as NEW |
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0007 |
Submit new dosage form This implies changes in module 1 around product information (SmPC, package leaflet and labeling) as well as in module 3. As this is an variation type II there are also modifications into the summary section related to quality (module 2) |
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0009 |
Submit new dosage form This implies changes in module 1 around product information (SmPC, package leaflet and labeling) as well as in module 3 As this is an variation type II there are also modifications into the summary section related to quality (module 2) |
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0011 |
Submit withdrawal of the production plant, which was added during life cycle 0005. There are new administrative files; all the files which were added in life cycle 0005 for module 3 are DELETEd |
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0012 |
Submit the second PSUR. This one is APPEND to the first PSUR submitted in life cycle 0006 |
Please feedback any issues to Geoff Williams - tel: 44 (0) 1494 568559.
Last updated 14 March 2003