Dear European Medicines Agency,
Under the right of access to documents in the EU treaties, as developed in Regulation 1049/2001, I am requesting documents which contain the following information:
Scientific Advice from the CHMP on 19 March 2008 (EMEA/H/SA/996/2008/PA/II)
In the EMA public assessment report on Defitelio (Defibrotide) manufactured by Gentium (I was very impressed by the scientific accuracy and stringency of the report!), I found the statement that the “applicant received Scientific Advice from the CHMP on 19 March 2008 (EMEA/H/SA/996/2008/PA/II). The Scientific Advice pertained to clinical aspects of the dossier.”
In order to improve our local Guidelines for Trials which are industry co-sonsored, the above mentioned document is of great importance for our Research Institute.
Re: ASK-6403 access to information request - documentation of the
Scientific Advice from the CHMP received on 18 November 2014
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Dear European Medicines Agency,
Under the right of access to documents in the EU treaties, as developed in Regulation 1049/2001, I requested in November 2014 documents which contain the following information:
Scientific Advice from the CHMP on 19 March 2008 (EMEA/H/SA/996/2008/PA/II). Unfortunately, I did not receive a copy of the document yet. may I kindly remind you to provide me with the respective Information.
Thank you for contacting the European Medicines Agency.
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