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Readability testing of Patient Information LeafletsSince 2005 Jacobsen Pharma AS has performed numerous tests and gained experience both at a national level as well as at a European level.
In some countries national deadlines have been laid down for submission of readability tests of package leaflets. It concerns:
- Belgium: deadline December 2011
- Hungary: deadline December 2010
- Spain: deadline July 2011
- Ireland: deadline October 2010
- Portugal: deadline December 2010
- Slovenia: deadline April 2011
- France: for all new applications, variations, and extensions
- Germany: for all new applications, variations, and extensions
Furthermore, it is a requirement that documentary proofs of readability tests are included at the initial starting of all MRP and DCP procedures irrespective of which European country is the CMS or RMS as well as for new national applications.
A test performed by Jacobsen Pharma AS will include:
· A readability test following the current European guidelines
· A rapid and conscientious completion of the test
· Delivery of the test results 4 weeks following placing the order
· Possible translation of the package leaflet in relation to the test
· Test results delivered as PDF-file (eCTD ready), paper version and on a CD-ROM
· Reply to possible inquiries from the authorities following submission
For further information about readbility testing, please feel free to contact us at info@jacobsenpharma.dk or +45 74441936. |
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| Nørre Havnegade 108, DK-6400 Sønderborg - Phone: +4574441936 - Fax: +4574441937 - E-mail: info@jacobsenpharma.dk |
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