Unlicensed medicines and use of PGDs

Jo Jenkins, Specialist Pharmacist (Patient Group Directions) SPS Medicines Use and Safety Division Published

Summary

The PGD legislation does not allow for unlicensed medicines to be supplied and/or administered. This page clarifies why a PGD cannot be used for the supply or administration of an unlicensed medicine.

Examples

  • 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.

Regulatory update November 2020

  • The regulations (specifically regulation 174 of the Human Medicines Regulations 2012) allow temporary authorisation for the supply of a medicinal product for use in specific circumstances.
  • An amendment to this regulation in November 2020 allows for the inclusion of medicinal products with a temporary authorisation 174 to be included within a PGD.

Implications for vaccines

  • The COVID-19 vaccines and some other vaccines e.g. Flublok have a temporary licence and therefore can be administered under a PGD since they are not unlicensed medicines.