Unlicensed medicines and use of PGDs

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This page explains why PGDs are not a legal mechanism for the administration or supply of unlicensed medicines.

Unlicensed medicines

The PGD legislation does not allow for unlicensed medicines to be supplied and/or administered.

Imported medicines

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.

Mixing of products

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 the 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.

Regulation 174 approved medicines

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.

The legislation was revised in 2020 to allow for the inclusion of medicinal products with a temporary authorisation 174 within a PGD.

Further information

Further SPS resources on unlicensed medicines are available via the following links:

Explaining the licensed status of medicines

Understanding unlicensed medicines

Using unlicensed medicines

Governance principles for unlicensed medicines

Making unlicensed medicines

Purchasing Specials

Video explainer

This video explains why unlicensed medicines cannot be included within a PGD.

Update history

  1. Addition of contents navigation and video explainer
  1. Minor formatting updates
  1. Additional links added to SPS unlicensed medicine resources
  1. Links to related SPS pages added
  1. Page reviewed. Specific detail on Regulation 174 vaccines removed. No other changes required.
  2. Published

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