INFARMED approves guidance on hospital-pharmacy magistral preparations of bacteriophages for individual patients (Deliberação 112/CD/2024)

On 15 November 2024 the board of Portugal's medicines authority INFARMED approved, in Deliberação n.º 112/CD/2024, a guidance note on compounded medicines for phage therapy in hospitals: magistral preparations of bacteriophages made in a hospital pharmacy on medical prescription for one specific patient. The treatment decision must be validated by the hospital's Ethics Committee and Pharmacy and Therapeutics Committee, phages must come with a certificate of analysis and meet the European Pharmacopoeia chapter on phage therapy medicinal products (5.31) and the Belgian monograph, and each treatment outcome must be reported to INFARMED using an annexed questionnaire.