Approval procedure for major variations Approval procedure for major variations United Kingdom Repealed Original text. Later amendments are not shown. 6Article 6 7Article 7 8Article 8 9Article 9 Notes on the whole EU Regulation Textual amendments F1 Repealed by Commission Regulation (EC) No 1085/2003 of 3 June 2003 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products falling within the scope of Council Regulation (EEC) No 2309/93 (Text with EEA relevance). Approval procedure for major variations