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’.

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. You can check the schedules on the list of controlled drugs.

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.

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 most commonly used drugs and the schedules to the Misuse of Drugs Regulations 2001 are listed in the controlled drugs list.

This list is not exhaustive: if the controlled drug you wish to travel with is not listed, please contact DLCU for advice.

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.

Applying for a licence: companies

Before you apply

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

DBS checks

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

DLCU has contracted Capita Recruitment Vetting Service (CRVS) to provide a scheme to enable DLCU licence applicants to obtain DBS enhanced disclosures. A DBS disclosure guidebook is available from the Capita Recruitment Vetting Service (CRVS).

To apply for a DBS enhanced disclosure contact CRVS on: +44 (0) 870 850 2516.

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.

Making your application

You can apply for a domestic licence to produce, supply or possess controlled drugs. This website requires a password.

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 licensing_enquiry.aadu@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.

Licensing exceptions: hospitals and universities

Private hospitals require licences for Schedule 1 and 2 drugs only.

NHS hospitals only require a licence for Schedule 1 drugs.

University research departments 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.

Once a licence has been issued it is the responsibility of the licensee to inform the Home Office of any adverse incidents.

Licensing exceptions: retail pharmacies

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 exceptions: social enterprises and community interest companies

The following reflects Home Office legal adviser’s branch opinion on the licensing requirements for possession of stocks of controlled drugs under the Misuse of Drugs Act 1971 for lawful administration to humans.

Hospitals and care homes

Licensing is not required if the organisation:

  • is operating the hospital/care home as a community interest company/social enterprise
  • the operational site is registered as such with the relevant healthcare regulator
  • the site is funded by at least 50% from public funds, charitable or voluntary subscriptions

The activity with controlled drugs is covered by regulations 8(2)(d), 9(3)(b),10(1)(a) and (c) and 4(3)(b) of the Misuse of Drugs Regulations 2001 to supply and possess the controlled drugs in Schedules 2 to 5.

Prison healthcare delivery

Licensing is required.

Activity with controlled drugs in these settings can only be authorised (where appropriate) by a licence issued under regulation 5 for the relevant schedule at the location concerned.

Out-of-hours and GP deputising services

Licensing is not required in the following scenario:

  • where the activities are being undertaken within this setting by practitioners, the organisation is authorised by virtue of their authority under regulations 8(2)(a), 9(2)(a),10(1)(a) and (b) and 4(3)(b) to supply and possess the controlled drugs in Schedules 2 to 5

Queries about licensing for social enterprises

You can email:

If you need further assessment of your organisation’s status, use the subject heading ‘SEO/CIC Status Request/organisation name’.

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.

See the hemp grower’s notes and MD29 application form guide which provides information on the licensing process for low THC cannabis. This information is intended for existing licensees and prospective growers who need to apply.

Making your application

You can apply for an industrial hemp licence. This website requires a password.

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.

We will accept paper based applications only until 8 April 2014, but we recommend that the online application is used.

All growers are required to complete and submit an annual hemp grower statement by 1 May 2014.

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.

There are 3 stages to the application process:

  1. register online
  2. fill out the overseas trading partners and preparations form, stating the anhydrous base drug in each substance and preparation
  3. email the form to dlcucommsofficer@homeoffice.gsi.gov.uk in conjunction with the registration for the NDS account

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 DLCU 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 DLCU 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 DLCU
  • 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: interim policy

The Home Office intends to hold a second consultation on the government’s policy on the import of oxycodone to the UK. The consultation, which will be launched in spring 2013 and will run for 12 weeks, will invite comments on 6 policy options for the licensing of imports of oxycodone in the UK. 2 of the options are new and were not subject to the first consultation exercise.

The interim policy on oxycodone remains in force. The UK will allow the import of oxycodone from within the EEA for re-export only. Small amounts may be imported from worldwide locations for research purposes.

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 Channel Islands export monthly return form (MS Excel Spreadsheet, 172KB) 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

The following fees apply for all application and renewal fees for controlled drugs licence applications.

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

Annual renewal 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 and export licences: application fees for new import and export drug licences

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

How will fees be paid?

From 6 August 2012 licensees who wish to pay for their licence fees by card will need to call the SSC payment line on the new number: 0845 010 0125.

Fees for all licences must be paid at the time of application, except for controlled drug and precursor chemical import/export applications, where charges will be accrued and invoiced on a quarterly basis.

You will be able to pay by one of the following methods:

  • Bankers Automated Clearing Service (BACS)
  • Clearing House Automated Payment System (CHAPS)
  • cheque
  • credit or debit card (ring 0845 010 0125)

What happens if my licence application is refused or withdrawn?

If an application for a new controlled drug or precursor chemical domestic licence, or to renew an existing one, is refused or withdrawn, a full refund of the application fee will be made.

If an application for an import/export controlled drug or licence or precursor chemical authorisation is refused or withdrawn, no charge will be included in any quarterly invoice.

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

From January 2014, annual compliance statements are part of the controlled drugs and precursor chemical application form as a series of declarations.

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 a different format.

If you use assistive technology and need a version of this document in a more accessible format please email alternativeformats@homeoffice.gsi.gov.uk quoting your address, telephone number along with the title of the publication ("Thefts and losses form").

Further information on drugs licensing

More publications are available in the drugs licensing series.

Contacting the Home Office DLCU

There are a number of ways to contact the DLCU, depending on your query:

  • if you are applying for a domestic licence, you can call the DLCU controlled drugs (domestic licensing) helpline on 020 7035 8972 or email them at licensing_enquiry.aadu@homeoffice.gsi.gov.uk
  • for information on import and export licences, you can call the DLCU controlled drugs (import/export licensing) helpline on 020 7035 6330 or email them at DLCUCommsOfficer@homeoffice.gsi.gov.uk
  • if you are applying for a precursor licence, you can contact the DLCU precursor chemicals licensing helpline on 020 7035 0792 or email them at PrecursorGeneralEnquiries@homeoffice.gsi.gov.uk
  • for queries or information on your annual returns, you can call the DLCU annual statistical returns (controlled drugs) helpline on 020 7035 0467 or the DLCU annual statistical returns (precursor chemicals) helpline on 020 7035 0484
  • if you would like to make a suggestion or complaint, contact the DLCU_Complaints_Section@homeoffice.gsi.gov.uk

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

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

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