Licences and registrations for controlled drugs

Annual licences and registrations

You will need an annual licence or registration for controlled drugs if you produce, possess, supply, import, and/or export controlled drugs. 

The type of licence needed will depend on the activity that you wish to perform. It also depends on the schedule that the controlled drug is listed in the Misuse of Drugs Regulations 2017 (as amended). See the table below for details.

*A separate controlled drug import or export licence/LONO is required for each controlled drug consignment to be imported/exported.

The licences shown in the table above are specific to controlled drugs. They are needed in addition to any other licence or authorisation that you might need for your business operation.

For example:

• If you manufacture medicines, you may also need a manufacturer's/ importer's authorisation. You can learn more about these licences at our Manufacturers page.
• If you wholesale medicines, you may also need a wholesale distribution authorisation. You can learn more about these licences at our Wholesale Distribution page.

How to obtain an annual licence or registration

You must complete an application form for an annual licence or registration. Please submit this to the Controlled Drugs section of the HPRA by email. A copy of this form can be found further below on this page. You should also submit any required supporting documentation to us by email. You will find this supporting documentation on the application form. Please seleted the type of activity and the controlled drug(s) which you require an annual licence or registration for on the application form. You must meet certain requirements relating to the type of activity and schedule(s) of controlled drugs for your application to be processed. These requirements are set out in the relevant legislation for controlled drugs. 

These requirements are related to:

• Security,
• Storage, and
• The documents and records that are kept for controlled drugs.

We may perform an inspection if you are applying for a licence for the first time. This is a normal part of our review process.

We may perform routine inspections after that. This is to make sure that operations continue to comply with the requirements for controlled drugs.

To learn more about our inspection process, please see our inspections page.

Fees for controlled drug licences must be paid to the Department of Health. For information on these fees, please see our fees page.

Application forms

You can download the application form for an annual licence or registration at the links below. Please send completed forms by email to the return details on the forms.

Import and export licences and Letters of No Objection (LONOs)

To import/export a consignment into or out of Ireland, you will also need an import/export licence or LONO. You can only apply for an import/export licence if you have an annual licence or registration.

Import and Export Licences

You will need an import/export licence if you are the company that is performing the physical import or export of any controlled drug listed in Schedules 1, 2, 3 or 4 Part 1.

Import or export licences must be applied for on NDSWeb. You can learn more about NDSWeb further down this page and in our Guide to NDSWeb extranet.

LONOs

You will need a LONO if you are the company that is performing the physical import or export of any controlled drug listed in Schedules 4 Part 2 or 5.

For controlled drugs in Schedules 4 Part 2, you must apply for a LONO on NDSWeb.

For controlled drugs in Schedules 5, you must apply for a LONO by email. You can learn more about applying for a LONO by email further down this page.

You can find more information about licences in our Guide to Import and Export Licences and Letters of No Objection for Controlled Drugs.

Guidance documents

What is NDSWeb?

NDSWeb is our secure online system for controlled drug import/export licences and LONOs (for Schedule 4 Part 1).

You can apply on NDSWeb for import/export licences and LONOs (for Schedule 4 Part 1).

We do not accept paper applications for import/export licences and LONOs (for Schedule 4 Part 1) from companies that also hold a Manufacturer's/Importer's or Wholesale Distribution Authorisation for medicinal products.

Fees for controlled drug import/export licences must be paid to the Department of Health. You must set up a credit account with the Department of Health for licences to be processed quickly. A licence cannot be processed until the fee has been received.

For information on fees, please see our fees page.

How to Register for NDSWeb?

You must provide us with certain information to set up your account on NDSWeb.

You can find a list of the information required to register in our Guide to NDSWeb extranet, a copy of which can be found above.

LONOs for controlled drugs in Schedule 5

You must provide us with certain information to apply for a LONO for a controlled drug listed in Schedule 5.

You can find a list of the information required in our Guide to Import and Export Licences and Letters of No Objection for Controlled Drugs, a copy of which can be found above.

Theft or unaccounted loss of controlled drugs

You must report all thefts or unaccounted loss of controlled drugs to us. Please complete and return the report form below.