All medicines including unlicensed medicines must be manufactured to GMP standards. The MHRA's non-binding advisory guidance which is under development is expected to provide more information on the manufacture of bacteriophage-based medicinal products. Compassionate use medicinal products can be imported into the UK via notification to the MHRA. The manufactured products are subject to review to ensure applicable GMP equivalence of the manufacture. Developmental pathways are not needed for these products as the phages do not need to be ‘developed’ apart from training on clinical samples. Any development following their initial use (adoption into a phage bank or developed as part of a licensed product) would no longer be for compassionate use and would therefore fall within the remit of existing regulatory frameworks. It is expected that phage based VMPs will be manufactured to phage adapted GMP. Guidance regarding these requirements is under consideration.