A company must not produce, supply, offer to supply, import, export or possess a controlled drug unless it is authorised to do so. Consequently, controlled drug licences are required by various sectors of the pharma-related industry and others including the following:
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 and may be conducted routinely thereafter to ensure maintenance of compliance.
Application forms for controlled drug licences can be found here.
The HPRA has developed a highly secure online licence application system for controlled drugs known as PharmaTrust. This system allows users to apply for import and export licences online. The HPRA does not accept paper applications for annual licences, import/export licences and ‘letters of no objection’ for controlled drugs from manufacturing and wholesaling companies.
To register for PharmaTrust, the following information should be provided to email@example.com:
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.
The HPRA have developed a guidance document to assist in the procedure for making an online application using PharmaTrust.