New guidance on controlled drugs requirements

The HPRA has published a new guidance document for operators on the documentation, storage and security requirements for controlled drugs, helping licence and registration holders meet their obligations under the Misuse of Drugs Act 1977 (as amended), and other Orders and Regulations made under it.

The guidance is intended for controlled drug operators, including manufacturers, wholesalers, forensic laboratories, pre-hospital emergency care providers and other entities.

The updated document follows a targeted consultation held in February 2026, during which the HPRA sought feedback from controlled drug operators and representative groups. We reviewed all submissions received and used stakeholder feedback to strengthen the guidance provided in the document. 

The guidance addresses a number of key issues raised during the consultation including:

• Electronic registers
• Background checks for personnel
• Transportation of controlled drugs
• Clarification on the definitions of 'Operator' and 'Responsible Officer'

To download the guidance and learn more about the updates and clarifications arising from the consultation, visit our webpage.