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This guidance has been issued to guide customers through the controlled substance application and case process.

Applications must be made online using the designated application portal .

We do not accept hard-copy applications or submission of documents by email in lieu in lieu of an application by the designated portal.

How do I register for your drug licensing system?

Before you can access the application system, you mustÌýfirst register as a user.

After registering, you will receive aÌýconfirmation emailÌýfromÌýDFLUÌýcontaining aÌýlinkÌýthat allows you toÌýdownload your application form.

YourÌýusername and passwordÌýwill beÌýautomatically generatedÌýand sent to you inÌýtwo separate emails.

Please ensure you check yourÌýspam/junk folderÌýif you do not receive these emails shortly after registering.

Your username and password do not provide instant access to the web-based licensing portal. Access will only be granted if your application is successful. ÌýPlease do not register more than once, as multiple registrations mayÌýdelay the processingÌýof your application.

Each registration is considered carefully on its merits taking account of the ability of the applicant to comply with regulatory standards in order to be issued with a licence under the terms of the Misuse of Drugs Regulations 2001. Therefore, it is important that you provide information that will support your proposals at this stage as it is where an initial view is reached as to whether your proposals have a prospect of success.Ìý

You will receive an email confirmation if your registration application is successful.

If you have not received a response to your registration request within 5 working days, and you have checked your spam/junk folder, please contact us via email at DFLU.dom@homeoffice.gov.uk if you have checked and When contacting us, use the following subject format: Registration query - Company Name – registration number.

What happens if I forget/lose my password or username?

If you have forgotten/lost your login details or need your password reset, please emailÌýdflu.dom@homeoffice.gov.uk When contacting us, use the following subject format: Password reset required - Company Name - Company Account Number

What happens if my registration application is unsuccessful?

If your registration application is unsuccessful, you can apply to register again. The new registration would be considered on its merit. However, you would need to address the points outlined in your unsuccessful registration application. If any future registration applications are made on the same basis of an unsuccessful registration application, they will not receive a response.

If any registration is rejected, you will be informed by email and given a reason for this.

How do I apply for a licence?

Log into the application portal and select the correct form; either:

• Controlled Drug licence application this includes all cannabis cultivation activities not covered by the hemp policy;
• Precursor Chemical Licence/ registration application; or
• Industrial Hemp (low THC Cannabis) cultivation licence.

Application forms can be saved in draft for up to five days. Please note:

• You will not receive a warning when the draft period is about to
• To avoid losing your progress and having to re-enter your details, ensure youÌýsubmit the form within five days.
• We areÌýunable to view or access formsÌýthat are still in draft status. We can only review your applicationÌýonce it has been submitted.
• Each section of the application form must be completed in full- including theÌýapplication declaration-Ìýbefore submitting’
• Once all sections are complete, submit your application by clicking theÌý‘Submit’Ìýbutton. Applications cannot be processed until they have been formally submitted.
• If you have not received a response to your application submission within 5 working days, and you have already checked your spam/junk folder, please contact us via email at DFLU.dom@homeoffice.gov.uk When contacting us, use the following subject line format: Application submission query - Company Name – submission reference number.

What is the ‘amendment’ form?

The amendment form must be used to make changes to an existing application you have lodged with us, but which has not been decided. For example, if you realise you have incorrectly named a drug.

Completing the amendment form is not an application in its own right. Nor can it be used to amend a licence which has already been issued or to apply for a further licence before the expiry of an existing one.

What information do I need to make the application?

ÌýThe following information is required when making an application:

Person Details

Names, business addresses, contact details, position of the people to be included on a licence- for example person in charge, authorised witness, person responsible for security, regulatory compliance etc.

Company or Organisation Details

What you do, type of business, funding sources (profit/ charity etc), (company/ charity) registration details e.g. Companies House certificates, other relevant licence details- e.g. CQC, MHRA licences, GPhC registrations, UKAS accreditation. Please note: if a registration is open-ended, you may still need to insert a future date in the box to proceed.

Licences/registrations requested

What you are asking for, in terms of activities (possess/ supply/ produce), Schedules and drugs to be held, Categories and chemicals to be held, and the reason you wish to hold licences/registrations- we need to understand why you are applying and be confident you are asking for appropriate licences/registrations.

Schedule 1 Research on humans (if applicable)

You must submit the Disclosure and Barring Service (DBS) details of the Principal Investigator, a copy of the research protocol, MHRA (if applicable) and ethics approvals along with the details and names of those that have been delegated authorisation to administer by the individual leading the trial.

Cannabis cultivation (if applicable)

You must submit information on the seed type/cannabis strain, location and type of premises, the number of plants you wish to cultivate- including details on how many harvests you anticipate undertaking within a calendar year, and information about projected growth (if applicable). You will need to explain what you intend to do with the material cultivated and how the products can lawfully be brought to market-either through your company or a licensed third-party- and provide details of the appropriate MHRA licences/registrations that are required to undertake these activities, research details and copies of protocols (if cultivating for research purposes) and your progress towards obtaining these;

Precursor chemical applications only

We require a letter of good conduct about the Responsible officer.

Disclosure and Barring Service (DBS) - formerly Criminal Records Bureau (CRB)- check details

We require an enhanced DBS check to be in place at the point of an application and obtained within the last three years through Security Watchdog:Ìý Ìýfor drug licensing purposes. When completing the online DBS check please enter DLCU in the Organisation reference box and licence in the organisation code box.Ìý Details of the check- disclosure certificate, date, name the check is conducted in- must be provided for each person named on the application. If you have applied but not yet received the DBS disclosure, you should only input the DBS application reference details if you/named individuals have passed the ‘completed identity (ID) stage’ i.e individuals have provided ID at the post office. If applications are submitted that have not passed this stage, they will be withdrawn. Please note a DBS application that is processing means that the overall application process clock will stop. Failure to ensure that your DBS is complete will result in a delay to your application and ultimately withdrawal of your application meaning you will need to reapply. For further information on the ‘update’ service see below. Please note that if your DBS check is more than three years old the form will not accept the date suggesting you will need to reapply. Please also note that DBS checks must be continuously valid throughout the life of a licence.

Premises details

Be able to describe your premises, and physical security arrangements.

Record Keeping and audit

What records, hard copy, electronic etc.

Supplier/ customer details

Where you are getting the drugs, and to whom you are intending to supply (where appropriate).

Destructions

How you intend to deal with waste/ destructions.

Documents

For example Standard Operating Procedures (SoPs), Technical Agreements, site layout, photos of safes/PSRs/record keeping- you can upload these to your application via the portal and should provide any relevant at the outset. There is a 10MB size limit.

Fee Payment and refund details

Who we send the invoice to, their contact details including email address and any Purchase Order number you need us to quote. We also ask for details to send you a refund if a situation arises where we need to return some of all of your payment to you.

Where the licence is to be sent to

Who we send the licence to their contact details including email address.

What about the DBS ‘update’ service?

DBS checks are NOT portable, unless you have subscribed to the ‘update’ service.

Information about this service should be dispatched with your disclosure certificate. You have a limited window to ‘opt in’ and there is a fee for this service. If you are part of a large organisation and may not see the letter directly, ask your employer.

Please note Drug Licensing do not handle the physical checks or any documents associated with your DBS application. If you have subscribed to the update service please note this in your application- You will need to provide written (email) consent/permission to verify/ check your details. This email should include your full name, date of birth, DBS certificate number and the application reference this is linked to

What happens after the form is submitted?

Upon submitting your application you will receive a confirmation email. This email will includeÌý a link allowing you to download a copy of your submitted form.

Please be aware that theÌýreference numberÌýautomatically generated by our web portalÌýdoes not confirmÌýthat your application has been successfully received. It simply indicates that you haveÌýstarted or completedÌýan application form.

If you do not receive an email acknowledgement, please:

1. Check your spam/junk folder

2. If the email is not there, contact us via email at DFLU.dom@homeoffice.gov.uk When contacting us, use the following subject line format: Application submission query - Company Name – submission reference number and include:

a. AÌýscreenshotÌýof theÌýsubmission confirmation pageÌýshowing theÌýreference number.

b. TheÌýdate and timeÌýdisplayed on your device at the time of submission.

This information will help us locate and verify your application.

If your application has been submitted and is considered as ‘complete’ as all component parts are in place i.e DBS completed, and all further information requested has been received etc, the following steps will occur:

Validation

We will firstly check your form and ensure it is valid. Improperly completed forms- may be rejected. Please fully complete the form with accurate information.

Triage

We will carry out an initial appraisal of your application and decide which ‘track’ it will follow- i.e. whether we need to visit your premises or whether we can consider your application on paper. At this stage it will be assigned for a compliance visit or to a caseworker for a paper-based consideration (no visit).

Visits - as required

We will contact you to arrange a visit if one is required. Please note we will not arrange a visit until your application is fully complete including any additional information requested by us.

Please allow up to 16 weeks for us to contact you to arrange a compliance visit if one is required.

Please note:

• all first-time licensees, new sites and upgrades are visited as an integral part of the consideration process and before the issue of a licence
• ‘Renewal’/ amendment/ further or additional licence applications may receive a visit before the issue of new licences- we will make a risk-assessed decision whether to visit. We aim to visit each site once every 1-5 years
• applications are only considered complete where all component parts of an application are correct and present
• if there is a delay because we have asked for more information regarding your application, it will take longer than 16 weeks to contact you to book a compliance visit
• the visit dates given are not negotiable and we require you to confirm your attendance.
• If you fail to facilitate the scheduled visit and/or inform us that you will not be attending, you will be provided with one further visit date after which time your application will be withdrawn, and a charge levied. There are also other circumstances in which a fee will be levied for more information on this, and the fees please refer to our website.

Further information- as required

If you are asked to submit further information, or confirm details, we will ordinarily give you a set timescale for this to be done. This may be done at a compliance visit, and/or by email if we are not visiting you.

Consideration and decision making

We will make a full and balanced decision on your application for a licence; where cases are complex this can take time. All recommendations will be subject to approval by a senior officer.

Fees payment

Occasionally, you may be asked to pay in full when we receive your application, and this payment may be required before your application is considered further. If this applies to your application, you will be informed by email as soon as possible. If you want to withdraw your application at this stage, you will not be charged.

If we refuse your licence application, any fees already paid will be refunded.

Assuming your application is successful, you will be issued an invoice by email for immediate payment. We will not issue a licence until we receive full payment and you will not be able to lawfully operate without a licence being issued.

If at any stage, you wish to cancel your application a cancelation fee may be applied to your application. For further information please view the ‘after I apply’ section on our website hereÌý

What happens at a compliance visit?

A compliance officer will normally be with you for a minimum of an hour and a maximum of 1 working day. They will discuss the application with those named on the application form, and physically visit the premises to be licensed, looking at systems, processes and the wider environment. Please note that the named responsible person must be present at the visit. If the responsible person is not present without prior agreement the visit may be cancelled and a charge levied. You may feel some of the material discussed will have been provided on your application form. This compliance visit will give you the opportunity to talk through and show how your company operates and complies with the Misuse of Drugs Act 1971 and associated regulations. ÌýDiscussing this with you is an important part of the consideration process to evidence your competence/ability to hold a controlled drug/precursor chemical licence. ÌýÌý

The Compliance Officer may set out recommendations which must be undertaken before we can consider issuing a licence. This could include, but not limited to, documenting processes- e.g. key/ combination lock security procedures, updating SoPs, installing a keysafe, or providing further information about your suppliers/ customers.

A timeline for completion will be set, however, where this is challenging we will always work with you to agree longer timelines. To note you must comply with the timescales set as failure to do so may delay your application or, in extreme examples, withdrawal of your application.

How do I prepare for a compliance visit?

Your assigned compliance officer will be in touch with you to arrange a date for their visit- please ensure all key personnel including the responsible person are available on the day of the visit, and advise us ASAP if there are any unavoidable changes to availability. Your compliance officer may request further documentation be sent to them before a site visit.

Please advise your compliance officer whether there are any specific site protocols (e.g. no food on site, clothing requirements), reporting or ID requirements. Your compliance officer will positively identify themselves to you, and expect to be asked to do the same, for example by showing your driving licence.

You should expect to be asked questions about your application, to physically ‘walk through’ the controlled drug process at your establishment, demonstrate your record keeping, illustrate key/ security arrangements and show us your drug stores.

Withdrawal of applications on account of failure to comply

We will withdraw an application where requested actions have not been undertaken in a reasonable or specified time. We will always contact you in writing (typically e-mail) setting out a timescale for an action to be taken, where we are intending to withdraw your application, so you have the chance to act.

It is your responsibility to ensure that DBS checks are complete at the time of application and that any actions required by you to obtain the DBS certificate are carried out in a timely fashion – for example by taking identification to the Post Office. Failure to manage your DBS application appropriately and ensuring that DBS checks are completed will result in either your application being delayed and / or the withdrawal your application being withdrawn. Failure to ensure that DBS checks are completed is the most common reason for an application being withdrawn. Applications cannot be reinstated

What happens if my application is refused?

If your application is refused you will have 30 calendar days from the date of the refusal letter to submit any further representations in respect of the decision, if you wish to. These will be considered accordingly.

You are free to re-apply but should only do so when you are in a position to provide additional information and directly addresses the reasons for refusal provided to you.

There is no option to appeal our decision to refuse an application or a decision to uphold that refusal following the submission of further representations. You have the option to take further action by following the Pre-Action Protocol for Judicial Review proceedings.

What does my licence/registration cover?

Controlled drug and precursor chemical licences/registration are:

• Time limited – valid for one year
• Premises and company specific (i.e. A B Drugs at 236a High Street)
• schedule and activity specific (controlled drugs only i.e. Schedule 2- possess & supply)
• Category, substance and activity specific (Precursor chemicals only i.e. Category 1 – Ephedrine - storage)
• Non-transferable (between premises or across drug schedules)
• Conditional - some conditions are standard to all licences, some may be dependent on schedules and activities and others are specific to the individual case situation. Conditions are reasonable, rational and proportionate and not for negotiation.

Please note that a licensee cannot subcontract the benefit of a controlled drug/precursor chemical licence which they hold to a sub-contractor. Only the Home Office can issue/amend/vary the licences which it issues.

Do you have any top tips for licensees or prospective licensees?

• If you are a new/ prospective licensee, remember to complete both the registration and application processes outlined above. If you do not, we will not have an application to consider.
• Do not apply to register as a user of a system unless you can show your proposals are compliant with all applicable UK laws and policies. We will not approve registrations or applications when there is no lawful route to market for a proposed product.
• Read the guidance on our website, especially information about fees and licence application handling, SoPs, Security and Transit Guidance.
• Apply early. New/ first time licence applications will take around 16 weeks to contact you to arrange a visit, from the point at which the application is complete. If you do not have DBS disclosures in place or have actions to complete before we can issue you a licence, this process could be much longer. Where we need to visit an existing licensee at the point of renewal timescales will be similar.
• For existing licensees, read the covering letter sent with your licence last year. This may give an indication if we intend to visit you the following year, and the fee associated with this, so you can plan ahead.
• Apply for ‘routine’ renewals where a visit is not required (details of whether a future visit is documented in the covering letter issued with the licence) at least 4-6 weeks before the expiry of your licence. If you do not apply before your licence expires, you may not be able to continue to trade.
• Provide us with as much information as you can at the outset, and use the facility to upload documents through the licensing form.
• Tell us any target timescales, or applications made to other regulatory bodies- e.g. MHRA- in free text on the application form. We cannot guarantee to meet those timescales, and the existence of a timescale does not mean we will automatically expedite a case. We may well withhold issue of a licence until other Regulatory Bodies approve their related applications, but you should not delay application waiting for, say, CQC approval for a premises to be issued.
• Settle your invoices promptly- we will not issue a licence until we have received full payment of the licence fee.

What happens if my company changes its name?

If you change your company name, this will invalidate your controlled drug/precursor chemical licence even where the Companies House number remains the same.

If your company is changing name and is being given a new companies house number this is considered to be a new legal entity. You will need to register for the drug licensing system under the new legal entity company name. Please do not re-register as a system user unless you are a new legal entity.

If your company name change remains the same legal entity, it is important you apply to amend your licence at the earliest opportunity. Do not wait until this has been completed by Companies House, if you do so, this will be at your operating risk as there is no licensing coverage.

When completing the application form please, complete the ‘Are you requesting a change of name’ box in ‘Step 1’ and in the ‘Additional Comments’ box you must provide the date the change is planned to occur. You must allow enough time for your application to be processed- we will not expedite late submissions. You should check the covering letter issued with your previous licence and if it indicated a compliance visit was needed at the next renewal point you must apply in adequate time for this to happen (Please refer to our website for timelines).

When you receive notification of a ‘decision in principle’ you should immediately pay the required fee and then contact DFLU 48 hours after payment. This is to ensure payment has been received and to formally notify us of your intention to proceed with the change at Companies House.

Please do not change the Change in company name until DFLU has agreed that they can accommodate the date for change.Ìý

You will be required to submitÌýthe acknowledgments of the change that you have received from Companies House via email, usually in the form of an email acknowledging receipt of the AD01 Change of Registered Address and NM01 Change of Company Name, toÌýDFLU.dom@homeoffice.gov.uk Ìýusing the following subject format: Company Name - Company Account Number - Agreed Change of Company Name - Submission.

Upon receipt of this, and payment, on the agreed date of the change we will issue the licence(s).

What happens if my company registered address changes?

If you change your company registered address at Companies House this will invalidate your controlled drug licence. It is therefore important you apply to amend your licence at the earliest opportunity. Do not wait until this has been completed by Companies House. If you do so, this will be at your operating risk as there is no licensing coverage.

When completing the application form please provide your existing Companies House registration details, complete the ‘Are you requesting a change of registration details’ box in ‘Step 1’ and in the ‘Additional Comments’ box you must provide the date the change is planned to occur. You must allow enough time for your application to be processed- we will not expedite late submissions. You should check the covering letter issued with your previous licence and if it indicated a compliance visit was needed at the next renewal point you must apply in adequate time for this happen (Please refer to our website for timelines).

When you receive notification of a ‘decision in principle’ you should immediately pay the required fee and then contact DFLU 48 hours after payment. This is to ensure payment has been received and to formally notify us of your intention to proceed with the change at Companies House.

Please do not change the Change in company registered address until DFLU has agreed that they can accommodate the date for change.Ìý

You will be required to submitÌýthe acknowledgments of the change that you have received from Companies House via email, usually in the form of an email acknowledging receipt of the AD01 Change of Registered Address and NM01 Change of Company Name, toÌýDFLU.dom@homeoffice.gov.uk Ìýusing the following subject format: Company Name - Company Account Number - Agreed Change of Registered Address - Submission.

Upon receipt of this, and payment, on the agreed date of the change we will issue the licence(s).

What if I need more help?

If this document, or the other resources on our website do not fully answer your question, you can contact us on our telephone number which can be found on our web page: Controlled drugs: domestic licences - ÌìÃÀÓ°Ôº (www.gov.uk) or email DFLU.dom@homeoffice.gov.uk Ìý

If you know to who your case has been assigned to, please contact the Compliance Officer or caseworker directly by using the email address that was used to send out your application acknowledgement letter.