The number of arbitration referrals (under Article 29 of the Community Code for medicines for human use, formerly Article 10 of Council Directive 75/ 319/ EEC, and Article 7(5) of Commission Regulation (EC) No 541/ 95) and the number of Community harmonisation referrals (under Article 30 of the Community Code, formerly Article 11 of Council Directive 75/ 319/ EEC) is not expected to increase from 2001 levels.