EMA approvals for technology used under trachea transplant trial TETRA

The request was refused by European Medicines Agency.

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".

Yours faithfully,

Leonid Schneider, independent science journalist
Taunusstr 11
63526 Erlensee

PF-15, European Medicines Agency

Dear Sir/Madam,
Thank you for contacting the European Medicines Agency.
Please note that this mailbox is not monitored. If you wish to submit requests for information or access to documents, please use the webform by following the link below:
For more information on ATD please refer to our guide on access to unpublished documents:
Best regards,
The European Medicines Agency

show quoted sections