vialroom
Thread · #uk-ireland · 2026-03-21

licensed, off-label, unlicensed and not-a-medicine-at-all

Spun off from a message in #uk-ireland on 2026-03-21. 5 messages, 1 participants.

The message this came from
  • peak_split — four different things and people use them interchangeably, which is where the panic comes from 18:21
PS

licensed means the MHRA has authorised that product for that indication. the pack, the dose range, the wording, all approved

off-label means an authorised product used outside the terms of that authorisation. a prescriber may do that, on their own clinical responsibility

unlicensed means the product itself has no UK marketing authorisation. specials, imports, compounded items. legal to prescribe, more paperwork, more responsibility on the prescriber

and then there is research-use material, which is none of the above. it is not a medicine, it was never assessed for human use, and no regulator has looked at it

that last category is the one this whole site sits next to and pretends not to. we should be honest that it is a different universe from the first three