En concreto, la genoterapia y la terapia celular somática debían cumplir el Reglamento a más tardar el 30 de diciembre de 2011 mientras que, en el caso de los productos de ingeniería tisular, el plazo para cumplir los nuevos requisitos vencía el 30 de diciembre de 2012.
However, a transitional period was foreseen for ATMPs that were already in the EU market when the Regulation was adopted. Specifically, gene therapy and somatic cell therapy were required to comply with the Regulation by 30 December 2011, while tissue-engineered products were required to comply with the new requirements by 30 December 2012.
