Title I - PROVISIONS OF THE CODE
CHAPTER I - Promotion of Prescription-Only Medicines
2. INFORMATION ON MEDICINES TO BE MADE AVAILABLE
2.1. All printed promotional material must include the following information clearly and legibly:
a) Essential information consistent with the data contained in the current summary of product characteristics, specifying the date on which it was prepared or last reviewed.
b) The medicine’s prescribing and dispensing conditions.
c) The different presentations of the medicine, where applicable, and the dosage and/or pharmaceutical form.
d) The public sale Price, the conditions for reimbursement by the National Health System, where applicable, and, whenever feasible, the estimated cost of treatment.
2.2. In audiovisual materials such as videos, films and the like, as well as in interactive systems, the information may be provided:
a) In a document made available to all persons to whom the material is shown or sent.
b) Included in the recording or interactive system. In this case, the information will be included as technically possible and adapted to the chosen medium, but in a manner that guarantees rapid and comprehensible access to the current summary of product characteristics. In this regard, if the information is included in an interactive system, the instructions for accessing the information must be clearly visible.
2.3. In accordance with national legislation, the advertising may, by derogation of the stipulations of paragraph 2.1, include only the name of the medicine, whenever the advertisement is intended only as a reminder and the medicine has been authorized for at least two years. In this case, the name of the medicinal product must be included and, when this is a brand name or a fantasy name and the product only contains a single drug substance, it must be accompanied by the Spanish Official Name or, if it does not have one, the International Non-Proprietary Name. The product logo and name and the company logo may also be included, but no other information.
2.4. Any printed information or documentation that pharmaceutical companies provide to the physician to be handed over to the patient on medicines that, due to the complexity of dosage, route of administration, etc., require the provision of additional information, as long as it is intended to improve treatment compliance, will not be considered a promotional material.