Please note that the FAMHP added a Q&A to their FAQ of Unmet Medical Need. It concerns the provision of medicinal products for free (or at a reduced cost) to patients when a Medical Need Program is not in place or has ended.

Is it possible to give a commercially available medicinal product for free or at reduced cost if for instance it is not possible to set-up an unmet medical need program or at the end of such a program for patients that do not fulfill the reimbursement criteria?

Yes, provided that the provision does not have the purpose of promoting the prescription, dispensing, supply, sale or consumption of medicinal products, and does not have the characteristics of advertising within the meaning of Article 10 of the Law of March 25, 1964 on medicinal products for human use. The normal distribution chain must be followed, i.e. the drug must be delivered to the patient by the pharmacist, in his pharmacy. (So no “direct to patient” by the manufacturer or the wholesaler).

Source: New Questions and Answers from the EMA regarding Titanium Dioxide in Medicines – ECA Academy (

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