the terms of that A food product A.2. Does the 4(including C.3. To identify or authorisation? substance function verify/compare its E.3 Does the assignment of dietary as a medicine i.e. adverse reactions? any patient involved in the supplements) can it be not presented as study to a particular administered to C.4. To study or therapeutic strategy fall a medicine human beings either verify/compare its within the current practice A cosmetic with a view to pharmacokinetics, e.g. and is not decided in product5 restoring, correcting absorption, advance by a clinical trial A medical or modifying distribution, protocol?7 device physiological metabolism or E.4 Is the decision to functions by excretion? prescribe a particular exerting a medicinal product clearly pharmacological , separated from the decision immunological or to include the patient in the metabolic action or study? to making a medical E.5. Will no diagnostic or diagnosis or is monitoring procedures be otherwise applied to the patients administered for a included in the study, other medicinal purpose? than those which are applied in the course of current A.3 Is it an active practice? substance in a E.6 Will epidemiological pharmaceutical methods be used for the form? analysis of the data arising from the study?
A.2. Does the substance function as a medicine i.e. can it be administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological , immunological or metabolic action or to making a medical diagnosis or is otherwise administered for a medicinal purpose? A.3 Is it an active substance in a pharmaceutical form? A food product 4(including dietary supplements) not presented as a medicine A cosmetic product5 A medical device C.3. To identify or verify/compare its adverse reactions? C.4. To study or verify/compare its pharmacokinetics, e.g. absorption, distribution, metabolism or excretion? the terms of that authorisation? E.3 Does the assignment of any patient involved in the study to a particular therapeutic strategy fall within the current practice and is not decided in advance by a clinical trial protocol?7 E.4 Is the decision to prescribe a particular medicinal product clearly separated from the decision to include the patient in the study? E.5. Will no diagnostic or monitoring procedures be applied to the patients included in the study, other than those which are applied in the course of current practice? E.6 Will epidemiological methods be used for the analysis of the data arising from the study?