Title I - PROVISIONS OF THE CODE
CHAPTER I - Promotion of Prescription-Only Medicines
3. INFORMATION ON MEDICINES AND ITS SUBSTANTIATION
3.1. Information on medicines must be accurate, balanced, fair, objective and sufficiently complete to enable the recipient to form his or her own opinion on the therapeutic value of the medicine concerned. It should be based on an up-to-date- evaluation of all relevant evidence and reflect that evidence clearly. It must not lead to confusion through distortion, undue emphasis, omission or any other way.
3.2. All graphic material, including illustrations, graphs and tables, must conform to the content and spirit of the Code. The graphs and tables must be presented in a manner that offers a clear, fair and balanced view of the topics covered and they must not be included unless they are relevant to the affirmations or comparisons being made.
Particular care must be taken to ensure that all artwork included in the promotion is not misleading with regard to the nature of a medicine (for example, whether it is appropriate for use in children) or with regard to a claim or comparison (for example, by using incomplete or statistically irrelevant information or unusual scales).
3.3. The information and statements on side effects must reflect the available evidence. It must not be stated that a product has no side effects, toxic hazards or risks of addiction or dependency.
3.4. In order to avoid adaptations that may introduce biases and cause confusion in the presentation of data, when the promotional material refers to published studies, the latter must be cited in a precise manner. In the case of tables or graphs, their reproduction must be literal. In accordance with the rules on publishing data, the reference to the published work must be included.
In this regard, and as an example, when efficacy, safety or other properties of different active ingredients are compared for the purposes of advertising, information such as the level of statistical significance of the results cannot be omitted, nor can the results of different studies or clinical trials be included in the same table or graph unless the source is a meta-analysis. Also, statistics, conclusions or any other data from different studies conducted with different methodologies cannot be mixed or compared unless they are derived from systematic reviews or meta-analysis in which the homogeneity criteria are expressed.
3.5. No exaggerated or general statements may be made, or statements that presume that a medicinal product, or an active ingredient, has some special merit, quality or property unless this can be substantiated.
3.6. The term "new" cannot be used to describe a medicine or presentation that has been widely available, or any indication that has been the subject of widely available promotion, for more than two years in Spain.
3.7. The brands or brand names of medicines from other companies can only be cited when unequivocally indicating in a clear and visible manner that they are the property of their marketer.
3.8. Comparative advertising must respect the norms of fair competition in all cases. It cannot be denigrating and comparisons must be based on comparable and relevant extremes. In all cases, and especially in comparative advertising, care must be taken to ensure that the sources that serve as a basis for the statements are valid and immediately accessible to the competitor.
3.9. Any information, claim or comparison included in the promotional material must be substantiated. This substantiation (or justification) must be provided at the request of physicians and other Healthcare Professionals who are authorized to prescribe or dispense medicines. In particular, any comparison that is made between different medicines must be scientifically verified. The statements related to the indications approved in the current summary of product characteristics do not need to be substantiated.