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 precursor chemical is a substance that may be used as starting materials for the illicit manufacture of a controlled drug.
Controlled drug licences are required by various sectors of the pharma-related industry and others including the following:
- Manufactures
- Distributors
- Academic institutions
- Private hospitals
- Cultivators
It is emphasised that controlled drug licences are issued under the Misuse of Drugs Acts, and are legally required in addition to other licensing requirements that may be applicable to the business operation e.g. a Manufacturer’s Authorisation, Wholesaler’s Authorisation etc.
To obtain a controlled drug licence compliance of the operation with the requirements for security, storage, and documentation, as set out in the various Regulations made under the Misuse of Drugs Acts must be demonstrated.
An inspection may be performed prior to the granting of a new licence application and may be conducted routinely thereafter to ensure maintenance of compliance.
For further information on Pharmatrust or on the transfer of the controlled drug licensing functions to the IMB please contact:-
Controlled Drugs Section,
Irish Medicines Board,
Kevin O'Malley House,
Earlsfort Centre,
Earlsfort Terrace,
Dublin 2,
Ireland.
Phone: +353-1-676 4971
Fax: +353-1-676 4061
Email: pharmatrust@imb.ie