Name and address of manufacturer or MA or PL holder: Name and address of authorised importing wholesale dealer: Country from where the import is to be made: SECTION 3 CLINICAL TRIAL DETAILS – 3.1 Nature and purpose of the clinical trial (objectives): 3.2 Target Species (only one per trial): 3.3 Indication(s) or outcomes / endpoints to be investigated: 3.4 Test Product: Product name / Pharmaceutical Method of Dose rate Duration of designation form administration administration 3.5 Control (positive or negative / placebo) product(s): Product name / Pharmaceutical Method of Dose rate Duration of designation form administration administration 3.6 Detail the type of individual who will administer the product to the animal (investigator, owner, other): 3.7 Procedure used in preparation of the products prior to administration and to achieve accuracy of dosing (where relevant): 3.8 Statement of target species safety warnings to be used for labelling, package leaflets, owner information sheets, etc. (refer to Annex 1):
Name and address of manufacturer or MA or PL holder: Name and address of authorised importing wholesale dealer: Country from where the import is to be made: SECTION 3 – CLINICAL TRIAL DETAILS 3.1 Nature and purpose of the clinical trial (objectives): 3.2 Target Species (only one per trial): 3.3 Indication(s) or outcomes / endpoints to be investigated: 3.4 Test Product: Product name / designation Pharmaceutical form Method of administration Dose rate Duration of administration 3.5 Control (positive or negative / placebo) product(s): Product name / designation Pharmaceutical form Method of administration Dose rate Duration of administration 3.6 Detail the type of individual who will administer the product to the animal (investigator, owner, other): 3.7 Procedure used in preparation of the products prior to administration and to achieve accuracy of dosing (where relevant): 3.8 Statement of target species safety warnings to be used for labelling, package leaflets, owner information sheets, etc. (refer to Annex 1):
_713603-v5_Application_Form_-_ATC_Type_S_.docx