Annex II GENERAL REQUIREMENTS TO BE SATISFIED BY THE DOSSIER PROVIDED FOR IN ARTICLE 3
United Kingdom
- GENERAL ASPECTS
- 1SECTION I: SUMMARY OF THE DOSSIER
- 2SECTION II: IDENTITY, CHARACTERISATION AND CONDITIONS OF USE OF THE ADDITIVE; METHODS OF ANALYSIS
- 3SECTION III: STUDIES CONCERNING SAFETY OF THE ADDITIVE
- 4SECTION IV: STUDIES CONCERNING THE EFFICACY OF THE ADDITIVE
- 5SECTION V: POST-MARKET MONITORING PLAN