Licences

Annual Licences and Registrations

Operators require a controlled drug annual licence or registration processed by the Health Products Regulatory Authority (HPRA), on behalf of the Department of Health, if they wish to produce/manufacture, possess, supply, import or export any controlled drug in the schedules to the Misuse of Drugs Regulations 2017, as shown below:

Activity

Regulatory requirements

Manufacture of any controlled drugs listed in the schedules

Annual licence, renewed each year

Supply, import, export or possess a controlled drug in Schedules 1 and 2

Annual licence, renewed each year

Supply, import, export or possess a controlled drug in Schedules 3, 4 and 5

Registration, not subject to renewal


It is emphasised that controlled drug licences are issued under the Misuse of Drugs Acts and are a legal requirement in addition to other licensing requirements that may be applicable to the business operation e.g. a Manufacturer’s/Importer’s Authorisation, Wholesaler Distribution Authorisation, etc. under medicinal products legislation (human or veterinary).

To obtain a controlled drug licence, compliance of the operation with the requirements for security, storage and documentation, as set out in the relevant legislation, namely the Misuse of Drugs Act 1977 and the various Orders and Regulations made thereunder, is necessary.

An inspection may be performed prior to the granting of a new annual licence or registration and inspections may be conducted routinely thereafter to ensure maintenance of compliance.

Annual Licence

Application for a Licence for Controlled Drugs (other than to Import or Export)

Registration

Application for Registration of Schedules 3, 4 and 5 Controlled Drugs

Import and Export Licences and Letter of no Objection (LONO)

In addition to an annual licence or registration, an import/export licence or LONO must be obtained to accompany each import/export consignment.

In order to obtain an import/export licence the company responsible for the physical import/export must apply for an import/export licence on PharmaTrust. In order to obtain a LONO for schedule 4,  part 2 the company responsible should also apply via PharmaTrust. (see below for further information on PharmaTrust) 

In order to obtain a LONO for schedule 5 controlled drugs, an application form should be requested from controlleddrugs@hpra.ie (see below for further information)   

It is not possible to apply for an import or export licence, or LONO, without holding an annual licence or registration.

Activity

In addition to an annual licence/registration: Regulatory requirement

Each import or export of controlled drugs in Schedules 1, 2, 3 and Schedule 4 part 1 into or out of Ireland

Import or export licence (as appropriate), to accompany the product

Each import or export of controlled drugs in Schedule 4 part 2 and Schedule 5 into or out of Ireland

Letter of no objection (LONO)


PharmaTrust

The HPRA has developed a 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 LONOs (with the exception of schedule 5 controlled drugs) from companies that also hold a manufacturer’s/importer’s or wholesale distribution authorisation for medicinal products. 
A credit account must be set up with the HPRA to facilitate the quick processing of licences.
Please note that we cannot process any applications until the fee has been received.

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

  • Name of company
  • Name of contact person and e-mail address
  • List of all controlled drugs products/substances to be imported or exported. Information on the strength of product, name of controlled drug active ingredient, pack size and volume of product (liquid preparations) should be included.
  • Names and addresses of foreign companies from/to which drugs or products requiring a licence are to be imported/exported, respectively.
  • Foreign import licence (required per export licence application)

     

LONOs for Schedule 5 Controlled Drugs

To request a LONO for a schedule 5 controlled drug, the following information should be provided to controlleddrugs@hpra.ie:

  • Name of company
  • Name of contact person and e-mail address
  • List of all controlled drugs products/substances to be imported or exported. Information on the strength of product, name of controlled drug active ingredient, pack size, volume of product (liquid preparations) and quantity to be import/exported should be included.
  • Names and addresses of foreign companies from/to which drugs or products requiring a licence are to be imported/exported, respectively.
  • Foreign import licence/LONO (required per export LONO application)

The HPRA has developed a guidance document to assist in the procedure for making an online application using PharmaTrust.

Guide to Import and Export Licences and Letters of No Objection for Controlled Drugs