1. Physicians may not prescribe a Medical Product for new uses not specified in the internal leaflet or electronic leaflet, or prescribe a Medical Product that has not been submitted for Marketing Approval, except when necessary, provided that there is no equivalent alternative available and with the patient approval. The compassionate use of the Medical Product is excluded from the provisions of this Clause. 2. It is prohibited for any licensed Healthcare Practitioner to advise, prescribe or dispense any Medical Product unless he is authorized to do so in accordance with the provisions of this Decree-Law, its Executive Regulations and the decisions issued in implementation thereof. 3. Healthcare professionals are prohibited from prescribing or advising any Medical Product for personal gain. 4. Free samples of Medical Products may not be provided to anyone other than licensed health professionals authorized to prescribe, for prescribing them to patients. 5. Licensed health professionals other than Pharmacists are prohibited from selling any Medical Product directly or indirectly except after obtaining the approval of the Ministry or the Competent Health Authority in coordination with the EDE. 6. The Executive Regulations of this Decree-Law shall specify the terms and conditions for the compassionate use of Medical Products.
Interpretation and application must be checked against the official text and current version.