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. Read the Executive summary for a complete overview:
executive-summary-proposed-amendments-european-commission-guidelines-variations-categories-procedures_en.pdf (europa.eu)
We will follow the updates closely and make sure to keep you updated.
RegFile AB
Eklundshovsvägen 1G,
752 37 Uppsala, Sweden
info@regfile.se
