7 July 2023
EMA/409815/2020 Rev.16

Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products.

Link para download do arquivo: 7 July 2023 EMA/409815/2020 Rev.16