Guidance

Controlled drugs: domestic licences

Information about controlled drugs licences for companies that possess, manufacture, produce or supply controlled drugs in England, Wales or Scotland.

Controlled drugs are drugs named in misuse of drugs legislation. You can check for the most common ones on the controlled drugs list. You can read the full lists in both the Misuse of Drugs Act 1971 and schedules 1 to 5 of the Misuse of Drugs Regulations (MDR) 2001.

If your company or organisation possesses, manufactures, produces or supplies controlled drugs in England, Wales or Scotland you will need to apply for a domestic license. If you already have a licence or are about to apply, read the general security guidance and the guidelines for standard procedures.

If your company intends to, or needs a licence to, transport controlled drugs you should read the transportation security guide, before you apply.

Before you apply

To apply, you first need to register as a customer on the controlled drugs licensing system. If your application is successful, you will receive a username and password. You do not need to register again each time you apply.

If you have forgotten your login details or need your password reset, please email dflu.dom@homeoffice.gov.uk.

You must make sure that each person named on the application form holds a valid Disclosure and Barring Service (DBS) check. The DBS check must be done by Security Watchdog. You can contact them on 01420 558 752 to apply for one. If you have a DBS check by another company, we cannot accept your certificate.

If you, or anyone named on the application, already has a DBS check in place for the purpose of drug licensing dated 3 years or older from Security Watchdog you will need to apply for a new DBS check.

If you have subscribed to the DBS update service, you should include this information in your licence application.

Apply for a domestic licence

Read the application guidance to help you complete your application.

You will need to include the controlled drug user activity list with your application.

Apply for a domestic licence to produce, supply or possess controlled drugs.

Fees

Our fees cover the costs of processing an application and are charged per licensing decision. The fee levels are set out in the Misuse of Drugs Regulations 2010. Read the full list of fees for controlled drugs licences.

After you apply

Allow up to 16 weeks for us to process your application. If your controlled drugs licence is approved, you will receive an email with instructions for payment. We will not issue your licence until the fee is paid. Once you have paid, the licence will be sent by post.

Compliance visits

We may need to visit your company to check for compliance with controlled drugs regulations. We will only arrange a visit if everyone listed on the application has a valid DBS check.

If you cancel your application

We consider how much to charge for cancellations case by case. You may be charged any costs already owed, relating to administration, travel or accommodation arrangements, if:

  • you cancel a compliance visit more than 48 hours after it is confirmed
  • you request to change the time or date of a compliance visit more than 48 hours after it is confirmed
  • you cancel your application after you receive an outcome from us

We may also ask for our administrative costs to be paid within 10 working days. We can email you extra information about these costs.

University research departments

You will not usually need a licence to possess and supply controlled drugs in schedules 2 to 5 of the Misuse of Drugs Regulations 2001.However, you will need a licence to produce any of those drugs and to also produce, possess or supply controlled drugs listed in schedule 1.

Hospitals, care homes and other healthcare providers

You may only require a licence for certain schedules and activities. This also includes social enterprise organisations, community interest companies and companies with charitable status. Read our guidance for healthcare providers.

Retail pharmacies that wholesale or supply

If you are a pharmacist undertaking a retail pharmacy business, you do not need a controlled drugs licence because certain limited licence exemptions exist in the Misuse of Drugs Regulations 2001.

If you need a wholesale dealer’s licence from the Medicines and Healthcare products Regulatory Authority (MHRA) for your business, you will also need a controlled drugs domestic licence. You can contact the MHRA on info@mhra.gov.uk to find out if you need a wholesale dealer’s licence.

Forensic analysts

If you undertake forensic analysis and/or are handling reference standards you can read the Information on controlled drug licence requirements for forensic work to find out when you need to apply for a controlled drugs licence.

Cannabis, cannabidiol (CBD), other cannabinoids and cannabis-based products for medicinal use in humans (CBPM)

Cannabis is a class B controlled drug listed in schedule 1 of the Misuse of Drugs Regulations 2001 and in the Misuse of Drugs Designation Order 2015. The Home Office acts as the National Cannabis Agency, as required by the UN Convention on the control of narcotics.

You can read the guidance on the domestic control measures for cannabis, CBD and cannabinoids.

Specialist doctors can lawfully prescribe cannabis-based products for medicinal use in humans listed in schedule 2 of Misuse of Drugs Regulations 2001 without a controlled drugs licence.

Companies that want to possess, manufacture, produce supply, import or export CBPMs need a controlled drugs licence. In some cases, limited exemptions are applied. For example, a community pharmacy that holds the product to dispense to an individual patient may not need a licence.

Cultivation of cannabis, regardless of THC content, is still an offence under section 6 of the Misuse of Drugs Act 1971, issued under regulation 12 of the Misuse of Drugs Regulations 2001.

If you apply for a licence to cultivate cannabis materials to produce a CBPM we will consider this individually and in line with the general drug licensing risk assessment process and other regulatory considerations. You should be able to fully explain how you will meet all applicable regulatory requirements to lawfully make a product available.

The industrial hemp cultivation policy does not allow for the use of the flowers or leaves (‘green’ or controlled materials) and does not apply here.

Mountain rescue teams

You can read about your responsibilities relating to controlled drug handling in mountain rescue situations. This is for teams affiliated to Mountain Rescue England and Wales (MREW), the Scottish Mountain Rescue (SM) and the Association of Independent Scottish Mountain Rescue teams (AISMR).

Thefts and losses

You can report any theft or unaccounted losses of controlled drugs by email to dflu.dom@homeoffice.gov.uk using the thefts and losses form.

Licence no longer needed

If your company no longer needs a controlled drugs licence you will need to submit a controlled drugs licence return premises closure statement. Even if you continue to trade but no longer handle controlled drugs you will need to submit a statement.

Personal information

You can read details of how we handle your personal information.

Contact details

Domestic licensing

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

Published 16 August 2019