Application Process and Requirements for Post-Approval Changes of Biological Products Adopting the World Health Organization Guidelines for Changes to Approved Vaccines and Biotherapeutic Products for Human Use; (91 page(s), in English)

Draft EEC Collegium Decision on amendments to the Rules for Classification of Medical Devices Depending on the Potential Risk of Use; (1 page(s), in Russian)

Draft resolution 1206, 02 October 2023; (6 page(s), in Portuguese)