#2026/381The Human Medicines (Amendment) Regulations 2026
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
This statutory instrument amends the Human Medicines Regulations 2012 by updating several key provisions including definitions, licensing requirements, and supply chain rules. It introduces a new regulation 235A, removes regulation 247A, and makes changes to Schedules 16, 17 and 26. The amendments focus on strengthening regulatory oversight of human medicines in the UK to better safeguard public health. The regulations come into force on 31 March 2026, just five days after being made on 26 March 2026.
AI-generated summary. May contain errors. Refer to official sources for legal decisions.
Key Changes
- Insertion of new regulation 235A concerning medicines regulation
- Omission (removal) of regulation 247A
- Amendments to regulation 3, 3A, 8, 19, 213, 233, 250 and 346 of the 2012 Regulations
+ 3 more changes with Pro
Obligations
What this law requires
Comply with amended regulation 3 definitions as updated by this instrument effective 31 March 2026
Comply with amended licensing requirements under regulation 3A as updated by this instrument effective 31 March 2026
Comply with new regulation 235A inserted by this instrument effective 31 March 2026
Cease compliance with regulation 247A, which is omitted effective 31 March 2026
Comply with amended supply chain rules under regulations 213, 233, and 250 effective 31 March 2026