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Lygarus

i am looking for a sample of a drug approval letter from the EMEA

Jack:

You may purchase reports that include such specimen letters from this EMEA resource ...

http://www.piribo.com/search/results.html?k=approval+letter
Here is the information required to file for approval ...

http://www.piribo.com/publications/regulation_policy/drug_approval_eu.​html

You may make a request to obtain existing approval filings directly from the EMEA at their website ...

http://www.emea.europa.eu/

For those who may not know (or care) the EMEA if the European Union's equivalent to the FDA, replete with every bit as much red tape and foot dragging. ;-)

Sequoia:

Eye on FDA: The EMEA and the FDAThe FDA also posts the Warning Letters and has a vast Web site that provides ... The reasons underlying changes in a drug’s marketing approval because of ...
www.eyeonfda.com/eye_on_fda/2007/01/the_emea_and_th.html - 55k - Cached - Similar pages

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