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:
All EMA documents referenced here:
"A positive opinion on EU orphan designation for the treatment of tracheal stenosis was given by the Committee for Orphan Medicinal Products (COMP) (application number EMA/OD/069/16) and then adopted by the European Commission on 29th October 2017 (application number EU/3/16/1717).
The product was classified as a Tissue Engineered ATMP according to Article 17 of Regulation (EC) 1394/2007 by EMA’s Committee for Advanced Therapies (CAT) on 9th November 2015 (Doc. Ref. EMA/CAT/650083/2015). However, the EMA have subsequently recommended a reclassification to a “combined ATMP” and this will be addressed in due course".
Leonid Schneider, independent science journalist
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