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Our role in regulating controlled drugs

What is a controlled drug?

A controlled drug is any substance that is listed in the Schedule of the Misuse of Drugs Act 1977. Any product or preparation that contains a controlled drug is also controlled. A substance can be classed as a controlled drug due to its potential to be abused or misused.

What is the law in Ireland?

The legal act around controlled drugs in Ireland is called the Misuse of Drugs Act 1977. The aim of the Act is to make sure that controlled drugs are available for medicine and science while at the same time preventing their misuse or abuse. The Act has been amended several times by new legislation.

There are also many regulations and orders that have been made under the Act.

The Act and all of the regulations and orders made under it are called the Misuse of Drugs Legal Framework.

The Act prohibits the import, export, production, possession, sale, and/or supply of controlled drugs.

However, these activities are permitted if performed under certain conditions that are set out in the law. For example, one of the conditions, in most cases, is that a licence is needed.

The Department of Health is the competent authority for controlled drugs. It issues controlled drug licences. We process controlled drug licences and perform associated inspections on their behalf.

You can find more information about the types of licences that are required for controlled drugs and how to apply for them on our licences page.

You can find more information about the law around controlled drugs on our legislation page.

What do we do?

  • We manage the process of applying for a controlled drug licence. We do this on behalf of the Department of Health. We get applications from manufacturers, wholesalers, universities, and state bodies.
  • We check whether applicants meet the requirements for a controlled drug licence. Some of the requirements relate to security, storage and the documents and records that are kept for controlled drugs.
  • We inspect many different controlled drug operators to make sure that they meet the requirements that are set out in the law.
  • We submit reports on behalf of Ireland to the International Narcotics Control Board.