The following classes of claims are subject to these requirements noted:
i) Market share and price claims, must be based on and referenced to, current authoritative data and must not state or imply therapeutic equivalence.
ii) Other non-therapeutic product claims, such as taste or packaging, require support from adequate, unbiased and statistically valid Data.
iii) Information from two or more TMA on products’ properties (Note 7) and on instructions for use or use limitations (Note 8) may be acceptable as side-by-side presentations and in text form. While the Code permits products to be accurately differentiated by these parameters, no clinical significance must be stated or implied where none has been proven, as is required under the Code for any statement. To ensure that clinical significance is not implied, a disclaimer may be required:
“Data from separate product monographs; comparative clinical significance has not been proven.”
Any such side-by-side presentation or statement must be complete, in that other data relevant to the presentation also contained in the TMAs must not be omitted. The presentation or statement must not be accompanied by a heading that implies an overall comparison of clinical efficacy or safety.