EMA: Atualização do perguntas e respostas para Nitrosaminas (07/07/2023)
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