The approval for advertising, publicity or promotion of Medical Products shall be issued by the EDE in accordance with the following conditions: 1. Valid Marketing Approval from the EDE for the Medical Product to be advertised. Products exempted from obtaining Marketing Approval in accordance with the provisions of Clause (3) of Article (5) of this Decree-Law are exempt from this condition. 2. The Applicant shall be a licensed pharmaceutical or healthcare Establishment. 3. The advertising material shall be truthful, not misleading, and supported by evidence reflecting the information and approved uses of the Medical Product. 4. The advertising material shall clearly disclose any risks or side effects associated with the Medical Product. 5. Fulfilling other conditions and controls for promotional advertisements in accordance with the target group, whether for health professionals or the public, in accordance with what is specified in the Executive Regulations of this Decree-Law.
Interpretation and application must be checked against the official text and current version.