This substance should never have been authorised in the procedure chosen for this purpose in view of the lack of preconditions and must be withdrawn from the market immediately.
Invalidity for breach of Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007, Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, and Regulation (EC) No 726/2004 of the European Parliament and of the Council, of 31 March 2004, laying down Community procedures for the authorisation and supervision of medicinal products for human use.
Violation of the EU legal provisions for the authorisation of "advanced therapy medicinal products"
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