A controlled drug is any substance, product or preparation specified in the Schedule of the Misuse of Drugs Act 1977. The Act has been amended on several occasions by subsequent legislation. The main objective of the Act is to ensure the availability of controlled drugs for medical and scientific purposes and to prevent the non-medical use of those drugs.
The Misuse of Drugs Act 1977, as amended, for example, by the Misuse of Drugs Act 1984, prohibits the import, export, production, possession, sale and supply of controlled drugs unless carried out in accordance with the terms outlined in regulations made under the Act.
Since September 2005, the HPRA has managed the application and issue process for controlled drug licences on behalf of the Department of Health. The HPRA carries out inspections of manufacturers and distributors of controlled drugs, as well as some other operators as required, ensuring compliance with the relevant requirements.