[' ', ' ', ' ', 'Inveresk', 'Research', 'International', '11', 'EEC', 'MULTI-STATE', 'REGISTRATION', 'PROCEDURE', 'FOR', 'VETERINARY', 'MEDICINES', 'As', 'previously', 'described', 'in', 'Bulletin', 'Number', '34,', 'the', 'Commission', 'of', 'the', 'EC', 'has', 'issued', 'proposals', 'to', 'amend', 'the', 'EEC', 'multi-state', 'registration', 'procedure', 'for', 'veterinary', 'medicines', '(the', 'CVMP', 'Procedure}.', 'The', 'operation', 'of', 'the', 'existing', 'procedure', 'is', 'described', 'in', 'a', 'compilation', 'of', 'the', 'EEC', 'legislation', 'on', ':', 'veterinary', 'medicines’', '-', 'this', 'volume', 'contains', 'the', 'latest', 'version', 'of', 'the', 'Notice', 'to', 'Applicants', 'for', 'Marketing', 'Authorisations,', 'which', 'supercedes', 'earlier', 'versions', 'issued', 'in', '1984', 'and', '1987.', 'The', 'current', 'Notice', 'to', 'Applicants', 'describes', 'the', 'practical', 'operation', 'of', 'the', 'procedure', 'in', 'greater', 'detail', 'than', 'the', 'earlier', 'versions', 'and', 'also', 'includes', 'changes', 'in', 'the', 'language', 'requirements', 'for', 'the', 'dossier', 'from', 'those', 'given', 'in', 'the', '1984', 'version', '(see', 'Bulletin', 'Number', '26,', 'page', '13).', 'The', 'basic', 'format', 'of', 'the', 'dossier', 'follows', 'that', 'for', 'human', 'medicines,', 'with', 'Parts', 'I', 'to', 'IY', 'covering', 'Summary', 'of', 'the', 'Dossier', '(includes', 'Expert', 'Reports),', 'Chemical/Pharmaceutical', 'documentation,', 'Pharmaco-', 'toxicological', 'documentation', 'and', 'Clinical', 'documentation', 'respectively.', 'For', 'veterinary', 'medicines,', 'Special', 'Particulars', '(product', 'labelling,', 'etc)', 'are', 'included', 'as', 'Part', 'VI', 'and', 'Part', 'V', 'covers', 'Experiences', 'in', 'Man.', 'The', 'revised', 'language', 'requirements', 'of', 'each', 'Member', 'State', 'for', 'the', 'various', 'parts', 'of', 'an', 'application', 'are', 'shown', 'in', 'Table', 'l.', 'Operation', 'of', 'the', 'Multi-State', 'Registration', 'Procedure', 'The', 'multi-state', 'procedure', 'is', 'initiated', 'by', 'the', 'applicant', 'sending', 'a', 'complete', 'dossier', 'directly', 'to', 'the', 'competent', 'authority', 'of', 'at', 'least', '5', 'Member', 'States', 'and', 'to', 'the', 'CVMP', 'Secretariat', 'in', 'Brussels.', 'Before', 'submitting', 'these', 'dossiers,', 'the', 'applicant', 'must', 'consult', 'the', 'authority', 'which', 'granted', 'the', 'initial', 'marketing', 'authorisation', '(MA)', 'and', 'agree', 'any', 'changes', 'which', 'may', 'be', 'necessary', 'to', 'update', 'the', 'dossier.', 'After', 'all', 'the', 'Member', 'States', 'concerned', 'by', 'the', 'application', 'have', 'acknowledged', 'receipt', 'of', 'the', 'dossier,', 'the', 'Secretariat', 'sends', 'a', 'telex', 'announcing', 'the', 'start', 'of', 'the', '120-day', 'period', 'allowed', 'for', 'Member', 'States', 'to', 'provide', 'their', 'objections', 'to', 'the', 'application.', 'Within', 'this', '120', 'days,', 'Member', "States'", 'questions', 'must', 'be', 'sent', 'directly', 'to', 'the', 'applicant,', 'the', 'Secretariat', 'and', 'the', 'authority', 'which', 'granted', 'the', 'initial', 'MA;', 'the', 'Secretariat', 'then', 'circulates', 'all', 'the', 'objections', 'received', 'to', 'all', 'the', 'Member', 'States.', ' ', ' ', ' ']