My HPRA: Register

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

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 NDSWeb. In order to obtain a LONO for schedule 4 part 2, the company responsible should also apply via NDSWeb (see below for further information on NDSWeb).

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)

NDSWeb

Please note the HPRA transitioned users from PharmaTrust to a new system called NDSWeb in January 2021. NDSWeb offers enhanced functionality and usability to support the licensing of controlled drugs.

The HPRA has developed a secure online licence application system for controlled drugs known as NDSWeb. This system allows users to apply for import and export licences online. The HPRA does not accept paper applications for 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 NDSWeb, the following information should be provided to controlleddrugs@hpra.ie:

Name of company
Name of contact person and e-mail address (It is recommended that this email address is a group email that can be accessed by all staff who will have a role in applying for controlled drug licences)
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 imported/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 is developing a guidance document to assist in the procedure for making an online application using NDSWeb and this will be published shortly.