Can patients receive unlicensed medicines under a PGD?

Jo Jenkins, Specialist Pharmacist (Patient Group Directions) SPS Medicines Use and Safety Division Source NHS PGD WebsitePublished

No, the PGD framework does not allow for unlicensed medicines to be supplied and /or administered.

For example, imported medicines (e.g. licensed in another country but not the UK) cannot be supplied or administered under a PGD and must be prescribed, or specified using a Patient Specific Direction.

The MHRA has advised that where two separate products are mixed together and one of them cannot be described as a vehicle for the administration of the other (for example as a diluting agent), this results in a new, unlicensed product. Therefore a PGD cannot be used for mixing of two licensed medicines, unless one is an diluent for the other, such as water for injection or specifically required for administration within the product SPC.

Update November 2020 – Regulation 174 of the Human Medicines Regulations 2012 allows temporary authorisation for the supply of a medicinal product for use in specific circumstances. An amendment to the Human Medicines Regulations 2012 introduced in the autumn of 2020 allows for the inclusion of medicinal products with a temporary authorisation under regulation 174 to be included within a PGD.