S.L. 437.47 Art. 93

Where the Director has reasonable cause to believe that an offence against these regulations has been committed and that it would be appropriate to impose an administrative penalty under article 61 of the Act, the Director shall proceed in accordance with the provisions of the said article 61 of the Act. SCHEDULE

REQUIREMENTS AND ANALYTICAL PROTOCOL, SAFETY TESTS, PRE-CLINICAL AND CLINICAL FOR TESTS OF VETERINARY MEDICINAL PRODUCTS

CONTENTS INTRODUCTION AND GENERAL PRINCIPLES

REQUIREMENTS FOR VETERINARY MEDICINAL PRODUCTS OTHER IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCTS

SUMMARY OF THE DOSSIER ADMINISTRATIVE INFORMATION SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET DETAILED AND CRITICAL SUMMARIES

PHARMACEUTICAL (PHYSICO-CHEMICAL, BIOLOGICAL OR MICROBIOLOGICAL INFORMATION (QUALITY))

principles and requirements QUALITATIVE AND QUANTITATIVE PARTICULARS OF THE CONSTITUENTS Qualitative particulars terminology

Quantitative particulars Development pharmaceutics DESCRIPTION OF THE MANUFACTURING METHOD

CONTROL OF STARTING MATERIALS General requirements Substances substances listed in pharmacopoeias substances not in a pharmacopoeia Physico-chemical characteristics liable to affect bioavailability

Excipients Container-closure systems substance

Finished Product Substances of biological origin CONTROL TESTS CARRIED OUT AT INTERMEDIATE STAGES OF MANUFACTURING PROCESS ON THE FINISHED PRODUCT