8. Post-Approval

• Type IA variations - minor variations ‘Do and Tell’ procedure.
• Type IB variations - minor variations ‘Tell, Wait and Do’ procedure.
• Type II variations - major variations.
• Extensions.

Guidelines on the details of the various categories of variations, on the operation of the procedures laid down in Chapters II, IIa, III and IV of Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicines for human use and veterinary medicines and on the documentation to be submitted pursuant to those procedures (2013/C 223/01).