The purpose of this document is to provide detailed guidance on the pharmaceutical quality assessment of unlicensed medicines. The principles are applicable both to unlicensed medicines sourced from other legal entities and unlicensed medicines prepared in house.

It supersedes the quality assessment element of the NHS Pharmaceutical Quality Assurance Committee’s “Guidance for the purchase and supply of unlicensed medicinal products: Notes for prescribers and pharmacists (2004)”.

Attachments

• qa-of-ulm · PDF · 2 MB