The MHRA states that the mixing of two separate medicinal products will result in a new, unlicensed product if one product cannot be described as a vehicle for the administration of the other e.g. as a reconstitution or diluting agent.
Unlicensed products cannot be supplied or administered under a PGD.
The PGD Board has worked with the MHRA to provide the examples in the below attachment to help organisations and practitioners make an informed decision as to whether their practice creates an unlicensed product.
These examples are not comprehensive and we advise any practitioner or organisation to contact their relevant professional body or regulator to obtain further advice on whether a particular practice is lawful when considering an appropriate method to prescribe, supply and administer medicines.
In addition, appropriate advice must always be sought from a pharmacist and/or Medicines Information Service on safety, stability and compatibility prior to carrying out any practice that involves mixing or altering the form of any product.