MHRA Flashcards
1
Q
What does regulation 167 of the Human Medicine’s Regulations 2012 outline specifically?
A
Regulation 167 of the UK’s Human Medicines Regulations 2012 outlines specific exemptions allowing the supply of unlicensed medicinal products (“specials”) under controlled conditions.
It must be:
1.Be supplied in response to an unsolicited order.
2. Be manufactured/assembled according to specifications from a UK-registered prescriber (doctor, dentist, nurse/pharmacist independent prescriber, or supplementary prescriber).
3. Address the “special needs” of an individual patient under the prescriber’s direct responsibility, where no licensed alternative is suitable
