Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025
What this means for your business
- Applies to
- United Kingdom
- On this page
- 2 compliance obligations, 1 practical guide
What you must do
2 compliance obligations under this legislation.
Management duties 1
Maintain records of serious adverse events and manage related risks
If your company sponsors a clinical trial, you must keep detailed records of any serious adverse events or reactions that occur, both in the UK and in overseas trials that meet the specified conditions. You also need to assess these events promptly, investigate the risks and put in place actions to minimise or prevent them.
Offences and prohibitions 1
Supply non‑investigational medicinal product with non‑compliant labeling for a clinical trial
If you (as a sponsor or any other person) sell, supply or arrange the sale of a medicinal product that is not part of the trial and the product’s label does not meet the requirements of regulation 46A, you commit a criminal offence. The sponsor offence does not require proof of knowledge, whereas the offence for other persons does. Conviction can lead to fines and/or imprisonment, but the exact penalties are set elsewhere in the regulations.
Penalties for non-compliance
1 penalty under this legislation.
Supply non‑investigational medicinal product with non‑compliant labeling for a clinical trial
Penalty applies
Practical guidance
Our guides explain how to comply with the requirements above.
Sections and provisions
45 classified provisions from this legislation.