What is the current legal situation for human phage application?

Currently, the problem in Europe is the missing regulatory framework for therapeutical use of phages that would explicitly mention and acknowledge the specific concept and unique mode of clinical use. 
The legal framework for use of medicines in Europe, mainly dictated by EU Directive 2001/83 on medicinal products for human use does not include phages and their regulatory allocation 
A number of systematic clinical trials was or is running in western Europe to demonstrate the safety and efficiency of phages. In contrast, phage therapy is routine in e.g. Georgia or Poland under the WMA Helsinki Declaration (Par. 37). Phages remain to be defined as therapeutics and integrated into a redesign of the EU directive. 
When a patient and the medical practitioner wish phage therapy, it is a precondition to use purified, characterized and strictly lytic phages. 
For comprehensive biological phage characterization, a large body of data for comparison and modern laboratory methods are available. The physician, together with the patient will decide about the successive therapy plan. Further reading: article by Isabelle Huys et al., see Literature recommendations.