UK Statutory Instruments, via legislation.gov.uk
The Human Medicines Regulations 2012, regulation 2A: definition of advanced therapy medicinal product
Regulatory · Tier 1, UK official · UK · 2012
Current — checked with the publisher on 2026-09-02
https://www.legislation.gov.uk/uksi/2012/1916/regulation/2A
What this platform has drawn from it — 1 claim
- In UK law, a gene therapy medicinal product is one whose active substance contains or consists of a recombinant nucleic acid administered with a view to regulating, repairing, replacing, adding or deleting a genetic sequence, and whose therapeutic, prophylactic or diagnostic effect relates directly to that sequence or its expression product. A vaccine against infectious diseases is not a gene therapy medicinal product.
Regulation 2A(2)(a) · Regulation 2A(2)(b) and 2A(3)
read on Gene therapy and the liver
How this record was checked, and what is doubtful about it
The statutory definition, held so that the word 'gene therapy' on this platform carries legal content rather than reading as a category of hope.
Verification: verified · last accessed 2026-09-02 · status checked against https://www.legislation.gov.uk/uksi/2012/1916/regulation/2A