Business and enterprise – guidance

Controlled drugs: licences, fees and returns

How to apply for licences to handle controlled drugs as a company or individual traveller, including import and export procedures and fees.

Overview

Companies and individuals in England, Wales or Scotland need to apply for Home Office licences if they wish to produce, supply, possess, import or export ‘controlled drugs’. For the purposes of the UN Convention on the control of Narcotics the Home Office additionally acts as, and discharges the functions of, the National Cannabis Agency.

Controlled drugs are named in the Misuse of Drugs legislation, and grouped in schedules. Anyone intending to produce, supply or possess a controlled drug must apply for the relevant schedule licence.

The list of controlled drugs is currently under review. Please contact DFLU.ie@homeoffice.gsi.gov.uk for advice on specific substances.

This guide explains how individuals travelling and companies can apply for controlled drug licences. It contains details of the application process, fees and other requirements including licensee statements and annual returns.

The Home Office issued open ended, “no time limit” licences, between January 2006 to November 2010. We have run a licence replacement programme for these types of licence. All companies, and individuals, holding open-ended licences were required to review their controlled drug requirements and, if they continued to need licensing, submit an application for a time limited licence by the end of their phase. Those who have failed to re-apply have had their open-ended licences revoked.

As a result, these open ended, “no time limit” licences are no longer valid. They should no longer be accepted for the purposes of handling, trading or supplying controlled drugs or precursor chemicals.

However, there are a small number of licence holders who have applications pending to replace these licences and will still hold an open-ended licence which has not yet been revoked. Those licensees will be aware of this, and will be able to either produce a copy of their application for a replacement licence, or an acknowledgement of that application. In such circumstances, they may also direct those enquiring about their licence status to us for confirmation that they have a pending application. We can only disclose this information however, with the explicit agreement of both parties.

Applying for a licence: travellers

Travellers who are carrying controlled drugs out of or into the UK for their own personal use may need a personal licence if:

  • they are travelling with controlled drugs listed under schedules 2, 3, 4 part I and 4 part II to the Misuse of Drugs Regulations 2001 for 3 calendar months or more
  • are carrying more than 3 months’ supply of controlled drugs listed under schedules 2, 3, 4 part I and 4 part II to the Misuse of Drugs Regulations 2001

The list of controlled drugs is currently under review. Please contact DFLU.ie@homeoffice.gsi.gov.uk for advice on specific substances.

Please use this form to apply for a personal import/export licence for controlled drugs.

Making a personal licence application

Please apply for a personal licence at least 10 working days before your travel date.

You will need to provide the following:

  • a completed application form for a personal export/import licence
  • a letter from your prescribing doctor or drug worker, which must confirm your name, travel itinerary, names of prescribed controlled drugs, dosages and total amounts of each to be carried

Overseas applicants

If you are applying from overseas for an import licence you should allow more time for your application to be processed and for the licence to be posted to you. We advise you not to make fixed travel arrangements before receiving the licence.

Travelling for less than 3 months, or with schedule 5 drugs

If you are travelling for less than 3 months and you are carrying less than 3 months’ supply of prescribed controlled drugs listed under schedules 2, 3, 4 part I and 4 part II to the Misuse of Drugs Regulations 2001, you will not need a personal import or export licence to enter or leave the United Kingdom.

If you are carrying prescribed drugs listed under schedule 5 to the Misuse of Drugs Regulations 2001 you will not need a personal import or export licence to enter or leave the United Kingdom.

In both cases we advise you to obtain a letter from your prescribing doctor or drug worker, which should confirm your name, travel itinerary, names of prescribed controlled drugs, dosages and total amounts of each to be carried.

If you are carrying prescribed medication which is not a controlled drug you are also advised to obtain the above letter.

Regulations in other countries

Other countries may have their own import regulations for controlled drugs and prescription medicines. We strongly advise you to check this with the UK-based representatives of the country or countries that you are travelling to or through.

Please find a list of contacts for embassies, consulates and High Commissions.

Importing patient-prescribed medicines to the UK

If you are intending to import medicines prescribed to you from outside the UK, you will require a Home Office import licence to lawfully do this. The only exception to this is if our ‘personal import policy’ applies (see above – applying for a licence: travellers). Importing patient-prescribed medicines into the UK therefore, includes UK and non- residents, who may only be temporarily staying in the UK (e.g., students, workers or long term visitors), where drugs are not carried ‘on the person’- e.g. sent via an international courier.

Controlled drugs - in schedules 2-4 (inclusive) of the Misuse of Drugs Regulations 2001 - typically contained in medicinal products include amphetamine, lisdexamphetamine and diazepam. Widely used painkillers containing hydrocodone, oxycodone or tramadol, and hormones such as testosterone and somatropin are also controlled.

This list is not exhaustive and your patient information leaflet should tell you the drug content of branded or generic medicines. Your doctor or pharmacist may advise if your medicine contains a controlled substance.

As legislation differs between countries, you should also check with the authorities in the exporting country to establish if an export licence is needed or any other requirements are necessary.

To obtain an import licence, you must to register for an NDS account (see below - applying for an NDS account). Once your registration has been approved, you may apply for an import licence.

Each licence costs £24. This must be paid for in advance and can only be used for one shipment. Your prescription and letter from your doctor will need to be uploaded in order for us to verify your application.

Please allow up to a maximum of 20 working days for us to verify and process your account and licence application, your payment and the posting of the licence to your address.

Licences cannot be issued retrospectively. Shipments that have been sent unlawfully may be seized by Border Force officials or held by courier companies. In these cases, they may be either destroyed or returned to sender.

Applying for a licence: companies

Before you apply

Prior to applying, all prospective and existing licence holders should read:

You should also:

  • download the controlled drug user activity list
  • apply for a Disclosure and Barring Service (DBS) enhanced disclosure for each individual named on the application form. If you (or any other individuals named on the application form) already have a DBS disclosure in place, obtained for drug licensing purposes through Capita within the last 3 years, you do not need to apply again.

DBS checks

The Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 enables DFLU to ask questions about spent convictions for the purpose of assessing applicants suitability to obtain a licence.

DFLU has contracted Security Watchdog (part of CAPITA PLC) to provide a scheme to enable DFLU licence applicants to obtain DBS enhanced disclosures. A DBS disclosure guidebook is available from the Security watchdog website.

To apply for a DBS enhanced disclosure contact Security Watchdog on: +44 (0) 114 241 3280 (Monday to Friday 9:00am to 5:30pm). During the call all aspects of the disclosure application process will be explained to you.

The contents of the DBS enhanced disclosures for all applicants named on the application form will also be taken into account in the decision as to whether or not to issue a licence.

Please also note that, as of 3 August 2010, compliance site visits will only be arranged with applicants once the Home Office has received confirmation that everyone named on the application has undergone a DBS check.

If you have subscribed to the DSB “update service” please include this information on your licence application and contact us for further information as to how this may be used.

Making your application

You can apply for a domestic licence to produce, supply or possess controlled drugs. This website requires a password. Please read the domestic licensing application guidance.

If you have not registered with us before as a customer please click controlled drugs and precursor chemicals registration. Existing licence holders should not register.

Existing licensees without a password should contact DFLU.dom@homeoffice.gsi.gov.uk.

Once we have received your online application, it will be assessed to ensure that the security and record-keeping requirements have been met.

Please allow up to 16 weeks for your application to be processed.

By applying for a licence you are accepting that we may request reimbursement of any travel, accommodation or similar administrative costs incurred by the Home Office, either in full or in part should you:

  • cancel, or request an amendment to the time/date of a site visit, more than 48 hours after being informed of your site visit date
  • request that your application is withdrawn at or after a compliance visit has been undertaken
  • request that your application is withdrawn, after a decision has been reached on your application

Any cancellations/withdrawal of application requests will be considered on a case by case basis following the principles above. Copies of any cost incurred will be provided on request and any applicable fees payable within 10 working days.

Licensing: universities

University research departments generally do not require licences to possess and supply drugs in schedules 2, 3, 4 part I, 4 part II and schedule 5, but they do require licences to produce any of those drugs and to produce, possess and/or supply drugs in schedule 1.

Licensing: healthcare

Hospitals, care homes and providers of healthcare in other settings may only require licences for certain schedules and/or activities. This includes establishments operating as social enterprise organisations, community interest companies, and those with charitable status. Please see guidance on domestic controlled drug licensing in healthcare settings.

Licensing: retail pharmacies undertaking wholesale/supply activities

For certain groups, eg pharmacists, the Misuse of Drugs Regulations 2001 (2001 Regulations) allow the possession, supply and production of drugs controlled under the Misuse of Drugs Act 1971 without the need for a Home Office controlled drug domestic licence (a limited licensing ‘exemption’). Similar provisions exist for persons conducting a retail pharmacy business.

Historically a small amount of ‘wholesale dealing’ has been permitted (maximum 5% turnover) without the need to obtain a Home Office controlled drug licence. This arrangement mirrored the exemption for pharmacists afforded by Section 10(7) of the Medicines Act 1968. With effect from 14 August 2012, Section 10(7) of the Medicines Act 1968 has been repealed.

The majority of retail pharmacies will continue to benefit from the Home Office licensing ‘exemption’. However, where a pharmacy requires a wholesale dealer’s licence from the Medicines and Healthcare products Regulatory Agency (MHRA) for its activities, it would also require a Home Office Controlled Drug domestic licence.

Enquiries about the need for a wholesale dealer’s licence should be addressed to the MHRA in the first instance info@mhra.gsi.gov.uk.

Nothing in this summary is intended to supersede the effect of the 2001 Regulations; a person wanting to carry out licensable activities in relation to controlled drugs must ensure they comply with their statutory obligations at all times and take their own legal advice as necessary.

Licensing: forensic analysis and reference standards

A factsheet on forensic analysis and reference standards has been prepared to help those undertaking forensic analysis and/or handing reference standards understand when they need to hold a Home Office controlled drugs domestic licence.

Mountain rescue teams

A factsheet has been prepared to assist mountain rescue teams, affiliated to either the Mountain Rescue England and Wales (MREW) or the Mountain Rescue Committee of Scotland (MRCoS), to understand their responsibilities related to controlled drug handling in mountain rescue situations. Please see mountain rescue teams: controlled drugs factsheet.

Industrial hemp

With effect from the 2012 growing season, we will issue licences to enable the cultivation of low THC varieties of cannabis sativa (industrial hemp) valid for 3 growing seasons.

The industrial hemp licensing factsheet provide information to new and existing growers on the licensing process for low THC cannabis.

Making your application

You can apply for a domestic licence to produce, supply or possess controlled drugs. This website requires a password. Please read the industrial hemp licensing guidance.

If you have not registered with us before as a customer please click controlled drugs and precursor chemicals registration. Existing licence holders should not register.

Existing licensees without a password should contact DFLU.dom@homeoffice.gsi.gov.uk.

Annual hemp ‘grower statement’

All growers are required to complete and submit an annual hemp grower’s statement by 1 May 2016.

Import and export licences

A company or other organisation that intends to import or export a controlled drugs and precursor chemicals will need the relevant domestic licence before they can apply for an import/export licence.

It will also need a National Drugs Control System (NDS) account to apply for any import/export licences. NDS is used to administer the import and export licensing regime of the United Kingdom.

Applying for an NDS account

NDS is designed to improve the processing times for licence applications and to assist in the capture of data for monitoring trade.

You can register online. Once the account is approved, overseas trading partners and preparations can be added.

Export licence applications

Companies wishing to make a controlled drugs export application will need to apply online for an export licence as soon as their NDS registration is complete.

Note the following:

  • licences will be valid for a maximum period of 2 months
  • licences will be issued for less than 2 months if the import permit from the importing country is valid for less than 2 months
  • licensees will need to ensure the original import permit from the importing country is sent to DFLU as soon as the licence has been submitted, so the application can be matched and processed (it is the responsibility of the exporter to ensure that the original import permit is tracked via their post system to the DFLU and a copy is retained in case of loss)
  • licensees will need to upload the import permit from the importing country onto the NDS system, but must ensure the original import permit is still sent to the DFLU
  • licensees will need to make sure their company reference number is sited in the notes field of their online application for each licence applied for
  • you should apply online via NDS

Import licence applications

Companies wishing to make a controlled drugs import application will need to apply online for import licence as soon as their NDS registration is complete.

  • licences will be valid for a maximum period of 3 months
  • licensees will need to make sure their company order reference number is sited in the notes field of their online application
  • licensees will need to note the Active Pharmaceutical Ingredients (API) country of manufacture in the notes field
  • you should apply online via NDS

Restrictions on exports of controlled drugs

On 20 December 2011 the European Union adopted a new EU-wide control on the export of certain drugs usable in execution by lethal injection.

These controls which came into force on 21 December 2011 were adopted as an amendment to annex III of Council Regulation (EC) 1236/2005 concerning trade in certain goods which could be used for capital punishment, torture or other cruel, inhuman or degrading treatment or punishment (the so-called “Torture Regulation”).

As a result of these EU imposed controls, exporters need to seek appropriate permission from national export control authorities to export to any destination outside the EU ‘short and intermediate acting barbiturate anaesthetic agents including, but not limited to’ the following controlled drugs:

  • Amobarbital (CAS RN 57-43-2)
  • Amobarbital sodium salt (CAS RN 64-43-7)
  • Pentobarbital (CAS RN 76-74-4)
  • Pentobarbital sodium salt (CAS 57-33-0)
  • Secobarbital (CAS RN 76-73-3)
  • Secobarbital sodium salt (CAS RN 309-43-3)

Exporters should refer to the guide on torture goods when exporting these drugs.

Importing oxycodone: consultation

Between 25 September and 20 November 2014, the Home Office held a consultation on the government’s policy on the import of oxycodone.

Read the response to the consultation

Export declarations

Companies holding blanket export licences should complete an export declaration form immediately following each shipment.

Export of controlled drugs to the Channel Islands

The Channel Islands (Jersey and Guernsey) operate their own licensing regime for controlled drugs. For UK exporters, this means that shipments of controlled drugs from the mainland UK to the Channel Islands must be covered by an appropriately issued export licence.

Frequent exporters

Companies making 24 or more shipments in a 12 month period can apply for a time-limited blanket export licence with the following terms:

  • licences will be valid for a maximum period of one year
  • licenses may be replaced annually and fall for replacement on 1 November 2010, irrespective of their date of issue
  • licensees will be responsible for ensuring applications for further licences are submitted no less than four weeks before the expiry of their existing licences
  • there is no automatic replacement, it is the responsibility of the licensees to apply
  • the decisions to issue licences are made on a case-by-case basis, taking into account all relevant factors at the time of the decision
  • the issue of a previous licence does not guarantee future issues

Use the frequent exporter licence application.

Occasional exporters

Exporters who make less than 24 shipments in a 12 month period will need to make an individual application for an export licence.

Occasional exporters will be required to apply for individual export authorisations for each consignment. Applications must be accompanied by a valid import permit from the competent authority.

Schedule 1 controlled drugs

Each shipment of schedule 1 controlled drugs will require:

  • an individual export authorisation application
  • a valid import permit from the requisite competent authorities
  • a domestic export licence

All exporters will be required to hold the relevant domestic controlled drug licenses for the appropriate schedules.

Monthly returns of exports

Exporters should complete the Channel Islands export monthly return form which must be sent to Channel_Islands@homeoffice.gsi.gov.uk.

Holders of frequent exporter licences must submit a monthly return form detailing the actual substances that have been shipped.

If you have not shipped for one month or more, then a nil return is required for each month that you have not shipped. If no monthly return form is received to cover each month you have held a licence, then your licence may be suspended.

Licence fees

Our fees are charged on a ‘full cost recovery’ basis. Fees are set at a level that allows the department to fully cover the cost of processing the application. Fees are payable for each licensing decision and there is no discretion to waive the fee. The applicable fee levels are set out in the Misuse of Drugs (licence fees) Regulations 2010.

Controlled drug domestic licences: application fees for new controlled drug domestic licences

Licensable activity/activities Licence application fee
Possess controlled drugs £3,133
Supply, or offer to supply, controlled drugs £3,655
Produce preparations containing controlled drugs £4,178
Produce controlled drugs £4,700
Cultivate cannabis £4,700
Cultivate cannabis with a THC content not exceeding 0.2% £580

Renewal/replacement of an existing controlled drug domestic licence of any type

Visit is required/not required Licence renewal fee
Where no compliance visit is required £326
Where a compliance visit is necessary £1,371

Controlled drug import/export licences: application fees for new import/export drug licences

Licence type Licence application fee
Individual export licence £24
Individual import licence £24

Controlled drugs domestic and import/export licences: Replacement for a lost, defaced or damaged licence

Lost, defaced or damaged £45

How will fees be paid?

Fees for all domestic controlled drugs licence(s) are invoiced once a decision has been made on an application, but before a licence is issued. Invoices for domestic licences are sent via email to the invoicing contact on the application form.

Fees for all import/export controlled drug licence(s) are invoiced in arrears at month end. Invoices for import/export licences are sent via standard post to the registered address on the customer account for invoicing.

If your organisation/company requires a purchase order (PO) number to be quoted, please ensure that you quote this at the point of the application being submitted or the invoice being raised. PO numbers can also be emailed to: DFLU.fees@homeoffice.gsi.gov.uk.

Fee payment can be made using one of the following methods:

  • Bankers Automated Clearing Service (BACS)
  • Clearing House Automated Payment System (CHAPS)
  • cheque
  • credit or debit card by calling Shared Service Connected Limited on 08450 100 125

Please ensure when making a payment that your invoice number is included, either on the cheque or in the reference section of your bank transfer.

Please send any remittance advice to:

Shared Service Connected Limited
HO Box 5003
Newport
NP20 9BB

Annual statistical returns

Wholesalers, manufacturers, producers and suppliers of controlled drugs must supply the Home Office with annual statistical returns on the specified form by 31 January each year. Please see the completion notes below for full details.

All other licence holders must submit a nil return by email, stating why they are not submitting a return, for example that they are not wholesalers.

You can email: annualdrugreturns@homeoffice.gsi.gov.uk

Licensee compliance statement

You no longer need to submit Licensee compliance statements unless you are surrendering your licence(s).

The licensee compliance statement has been incorporated into our new application form so you do not need to complete and return one separately. Each time you complete an application form applying for a controlled drugs domestic licence, we will be able to obtain the information that we require.

If you no longer require your licence(s) then a compliance statement should be completed stating that the licences are no longer required. You will find the form under the heading how do I surrender my licence or registration?.

Licensee compliance statement is not to be confused with the annual drug returns. This is a separate exercise. To find out if you need to complete the annual drug returns please email:

annualdrugreturns@homeoffice.gsi.gov.uk

Industrial hemp growers will still need to submit their annual hemp grower statement by 1 May each year.

Thefts and losses of controlled drugs

Report any losses using the form:

Thefts and losses form

This file may not be suitable for users of assistive technology. Request an accessible format.

If you use assistive technology (eg a screen reader) and need a version of this document in a more accessible format, please email alternativeformats@homeoffice.gsi.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

How do I surrender my licence or registration?

A CD/PC licence return premise(s) closure statement should be used in situations where a company no longer requires their controlled drugs licence, precursor chemical licence or registration at the named premises written on their licence/registration. This includes site closures and companies that wish to no longer handle controlled drugs or precursor chemicals but are continuing to trade.

Controlled drugs licence return premise(s) closure statement

This file is in an OpenDocument format

This file may not be suitable for users of assistive technology. Request an accessible format.

If you use assistive technology (eg a screen reader) and need a version of this document in a more accessible format, please email alternativeformats@homeoffice.gsi.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Further information on drugs licensing

More publications are available in the drugs licensing series.

Drugs and Firearms Licensing Unit (DFLU) contact details

Depending on your query, there are a number of ways to contact the DFLU

Domestic licensing

This address deals with domestic (UK) controlled substance licenses including precursor chemicals, applications, renewals, compliance visits, thefts & losses, surrender or returning licence, or general enquiries about domestic licensing.

Import/export licensing

This address deals with the import/export of controlled substance into or from the UK, import/export licenses, applications, endorsements of licenses, or general enquiries about import/export licensing.

Licensing fees

This address deals with fees, invoices and billing queries for drugs licensing, domestic and import/export.

Customer complaints

This address deals with customer complaints about import/export or domestic licensing of controlled drug, precursor chemical or industrial hemp licensing.

Organisation chart for specific sections of DFLU

For more general queries, you can write to the DFLU at this address:

Drugs and Firearms Licensing Unit
5th floor SE, Fry building
2 Marsham Street
London
SW1P 4DF