Health

#2026/381The Human Medicines (Amendment) Regulations 2026

🇬🇧United Kingdom··Statutory Instrument·Medium Impact·View source ↗

AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.

🇬🇧 English

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

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Affected Parties

Pharmaceutical manufacturersMedicines wholesalers and distributors+4 more…

Tags

pharmaceutical regulation,medicines licensing,public health
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