Our Role

Controlled Drugs

• A controlled drug is defined as any substance which due to its potential for misuse and or abuse, is listed in the schedule to the Misuse of Drugs Acts 1977 and 1984.
• A licence is needed to legally permit importing, exporting, manufacturing or holding controlled drugs.
• Our role is to review each application received for a controlled drug license. We may carry out an inspection prior to granting a new licence.
• We evaluate applications from various sectors of the pharma-related industry such as manufacturers, distributors and academic institutions. We assess their compliance with security, storage and documentation requirements.  Each licence is issued by the Department of Health.

Prescursor Chemicals

• Precursor chemicals are used in the manufacture of licensed medicines, certain food stuffs and for other scientific or laboratory uses.  These are raw chemicals which if procured by illegal sources could be used for illicit purposes.
• Our role is to regulate the movement of precursor chemicals. We assess, register and approve import or export authorisations for such chemicals.
• The HPRA’s role also extends to inspecting, as required, these products when they come into Ireland or when they are exported from the country.