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.              

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.

Pharmatrust is an electronic application system which allows companies to apply for licences online. The Irish Medicines Board no longer accepts paper applications for annual licences, import/export licences and ‘letters of no objection’ for controlled drugs from manufacturing and wholesaling companies. As PharmaTrust is an online application system, the process of application is quick and efficient.

To register for PharmaTrust, the following information should be provided to controlleddrugs@imb.ie:

• Name of company
• Name of contact person and e-mail address
• List of all controlled drugs and imported or exported products. Information on strength of product, name of controlled drug active ingredient, pack size and volume of product (liquid preparations) should be included on this list.
• Names and addresses of foreign companies where drugs or products requiring a licence are imported to or exported from.

Precursor Chemicals

A precursor chemical is a substance that may be used as starting materials for the illicit manufacture of a controlled drug.  

In January 2010 the Irish Medicines Board was nominated as Competent Authority for precursor chemicals with regard to the following activities:

• Licensing
• Registration
• Import/Export Authorisation
• Annual and Quarterly Reporting
• Inspection

For current legislation on precursor chemicals, see attached links on the top right of this page and click legislation.

Click here for an application form for a licence or registration of a precursor chemical.

Contact us

For queries relating to controlled drugs or precursor chemicals 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: controlleddrugs@imb.ie


Information and guidance

Guide to PharmaTrust

Click here for the presentations from our information day on precursor chemicals.