Title I - PROVISIONS OF THE CODE
CHAPTER II - Interaction with Healthcare Professionals and Organizations
13. MEDICAL SAMPLES
13.1. In accordance with national law, a limited number of free samples may be supplied to Healthcare Professionals who are authorized to prescribe medicines so that they can become familiar with new medicines, provided that such provision is in response to a request from them.
13.2. Samples may be provided for a maximum of two years from the date the medicine obtained the marketing authorization.
13.3. A sample of a medicine must not be larger than the smallest presentation of the medicine available in the national market.
13.4. Each sample must bear the statement "free medical sample – not for sale", and the coupon must be crossed out or removed. Each provision of samples must be accompanied by a copy of the current summary of product characteristics, together with updated information on the price, reimbursement conditions of the National Health System, where applicable, and whenever possible, the estimated cost of treatment.
13.5. The provision of samples that contain psychotropic or narcotic substances as defined in international treaties is prohibited, as is the provision of samples of medicines that can lead to dependence or create public health problems due to their inappropriate use, and other medicines so determined by competent health authorities.
13.6. Samples distributed by pharmaceutical company personnel will be provided directly to Healthcare Professionals authorized to prescribe medicines who have requested them, or to individuals authorized to receive them on their behalf.
13.7. When distributing samples in hospitals, the requirements and procedures of the hospital in question must be respected.
13.8. Companies must have an appropriate monitoring and accounting system for the samples they distribute.