The regulatory “bible” for approved products is changing. Obviously, we are talking about the “EC guidelines on variations categories and procedures”. Be prepared and check out the proposal for stakeholder consultation: european-commission-guidelines-variations-categories-procedures-proposal-stakeholder-consultation-track-changes_en.pdf (europa.eu) There are many changes in this version, relating to IA super grouping, work-sharing, flexibility for vaccines, addition of API suppliers and more.… Fortsätt läsa On top of the upcoming guidelines
