The Human Medicines (Amendments Relating to Naloxone and Transfers of Functions) Regulations 2024
The Human Medicines (Amendments Relating to Naloxone and Transfers of Functions) Regulations 2024 were made on 11th November 2024 and came into force on 1st December 2024.
These Regulations amend the Human Medicines Regulations 2012 to:
- Extend the list of persons who are exempt from the requirement to hold a controlled drug licence in order to possess, supply or administer naloxone where it is being used for the treatment of an opioid overdose.
- Transfer functions relating to the regulation of human medicines from the Secretary of State to the Medicines and Healthcare products Regulatory Agency (MHRA).
1. Extension of the naloxone exemption
The Human Medicines Regulations 2012 currently exempt the following persons from the requirement to hold a controlled drug licence in order to possess, supply or administer naloxone:
- Doctors
- Dentists
- Pharmacists
- Nurses
- Midwives
- Health visitors
- Paramedics
- Police officers
- Firefighters
- Prison officers
- Customs officers
These Regulations extend this list to include:
- Anyone who is trained in the use of naloxone and who is acting in accordance with those instructions.
- Anyone who is providing naloxone to someone who is at risk of an opioid overdose.
- Anyone who is administering naloxone to someone who is experiencing an opioid overdose.
This change will make it easier for people to access naloxone and will help to save lives.
2. Transfer of functions to the MHRA
The Regulations transfer functions relating to the regulation of human medicines from the Secretary of State to the MHRA. This includes functions relating to:
- The licensing of human medicines
- The marketing and advertising of human medicines
- The safety and efficacy of human medicines
This change will streamline the regulation of human medicines and will ensure that the MHRA has the necessary powers to carry out its functions effectively.
Conclusion
The Human Medicines (Amendments Relating to Naloxone and Transfers of Functions) Regulations 2024 are an important step forward in the fight against the opioid crisis. They will make it easier for people to access naloxone and will help to save lives. They will also streamline the regulation of human medicines and will ensure that the MHRA has the necessary powers to carry out its functions effectively.
The Human Medicines (Amendments Relating to Naloxone and Transfers of Functions) Regulations 2024
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