Controlled Drugs (CDs) are prescription medicines that are controlled under the Misuse of Drugs Regulations (2001) and the Misuse of Drugs Act (1971).

You can find the list of controlled drugs here.

If you are supplying controlled drugs (CDs) in either the UK or overseas (or both), are you sure you have the correct licenses in place?

You will need to apply for a Controlled Drugs Licence through the Home Office, as well as having a Wholesale Distribution Licence. This is applied for through the MHRA and is required for supplying any medicines.

You will need to have either a domestic licence, if you are only planning on supplying with the UK, or an import/export licence if you plan on doing either/both of these or both licences. Whether you need one ot the other or both depends on the activities you are planning on carrying out.

Controlled Drugs Licence Application Process

• This is carried out through the Home Office’s portal – you will need to register on their Controlled Drugs Licensing System.
• Every person that you are naming on the licence will need to be DBS checked.
• The Home Office will arrange a visit to the site to perform an inspection (when they have got confirmation of the DBS checks).
• There are 4 key roles that need to be named during the process:
  • The Person in Charge
  • The Person in Charge of Security of the site
  • An Authorised Witness
  • The Responsible Person (RP)
• A Compliance Officer from the Home Office will carry out the inspection of your company. They will review your SOPs, documentation and operations in order to assess their compliance with the relevant guidelines/legislation. The outcome of this inspection will determine whether you are able to carry out the activities you are applying for (whether you will be approved for the licence).
• Any deficiencies that are found during the inspection will need to be closed out with evidence of this or any actions that will be taken, in order for you to be approved.

You must be compliant with the security guidance for controlled drugs licensees and the guidance on security measures when transporting CDs. The inspector will be checking fo evidence of this.

Maintaining Compliance

Your site will be reinspected annually to renew the licence, meaning that you will need to ensure that compliance is maintained at all times in order to keep the licence (which as Good Distribution Practice you should be doing anyway!) You must provide the Home Office with your annual statistical returns form every year by the end of January. You can find guidance on this form here.

Are you looking to add Controlled Drugs to your existing licence, or considering applying for a fresh licence? Or do you know or even suspect your company’s  Good Distribution Practice may not be sufficiently robust enough to meet inspection standards? Are you aware of a lapse of attention to the SOPs by personnel and up-to-date training is required?

Support and Assistance

If you need help or support with your Controlled Drugs Licence application or with ensuring compliance (as well as ongoing compliance) within your company, we can help. Get in touch with us using the Contact Form below to arrange a free initial consultation where we can discuss which of our services will best meet your requirements. Remember to provide us with a brief summary of who you are, your company, your intended business associates (sources and clients etc) and what you believe you need.

Have a look around our courses too, using the link button below. Our Controlled Drugs training course is CPD Approved. Use the link button below to overview the course details and make a booking.

We hold a monthly all-day Webinar with clients from all over the UK that covers all the EU GDP Guideline Chapters. There are discounts for group bookings.

Applying and qualifying for a new licence is an expensive business and Paradigm Shift Consulting will never lead a company through the process of application while knowing that you may not be well positioned to achieve it, and take your money regardless. That is NOT the way we operate.