EN PL

Public consultation on Annex 2 of the GMP laying down the guidelines for the manufacture of biological medicinal substances and products for human use

27.04.2010
Annex 2 is proposed to be revised as a consequence of the restructuring of the GMP guide, the increased breadth of biological products to include several new product types such as transgenic derived products and the Advanced Therapy Medicinal Products, (ATMPs) together with associated new legislation. Significant changes have also been made as a result of the comments received from the first consultation.