For those familiar with my background, you may recognize me from my days as an MHRA inspector and, more recently, my time in industry supplying pharmaceuticals to the aviation and maritime sectors. I’m eager to share the practical insights I’ve gained managing the global distribution of controlled drugs.

Controlled drugs are known to be susceptible to misuse and abuse, and therefore necessitate a stringent and secure supply chain environment. This article explores:

• Practical safety and security measures to uphold supply chain integrity.
• Delving into the requirements for obtaining and maintaining necessary licenses.
• Expectations of regulatory bodies.
• Key challenges associated with distributing these substances.
• The crucial role of worldwide collaboration between regulatory bodies and competent authorities in safeguarding public health and preventing diversion, misuse, and abuse.

The inherent risks associated with controlled drugs often deters a wholesaler from including them in their product portfolio. However, it’s vital to acknowledge the legitimate reasons and uses for these substances. For instance, morphine for postoperative pain relief or diazepam for treating anxiety disorders. When prescribed and dispensed under the supervision of healthcare professionals and adhering to strict regulatory guidelines, certain controlled drugs can provide substantial benefits to patients. Nevertheless, meticulous control and supervision are paramount to prevent any potential abuse or misuse.

If you plan to distribute controlled drugs, navigating licensing can be tricky. Wholesalers can face delays when applying for category 3.1.1 (Narcotic or psychotropic products) on their MHRA wholesale distribution authorisation (WDA) because they are unexpectedly asked for evidence of their domestic licence application with the Home Office. This requirement underscores the intricacies of licensing under the Misuse of Drugs Act 1971 and Misuse of Drugs Regulations 2001 (or the Misuse of Drugs Regulations (Northern Ireland) 2002), which establish the legal framework for controlled substances in the UK and Northern Ireland.

The Home Office is responsible for managing licensing, oversight, international compliance, enforcement, and legislative development for controlled substances for Great Britain. The Department of Health for Northern Ireland carry out a similar role.

To distribute controlled drugs as a wholesaler, a domestic license from the Home Office or Department of Health (Northern Ireland) is as vital as your MHRA WDA (H) application. Submitting both applications simultaneously helps prevent delays.

The domestic license application, expectations of the Home Office and inspections

The domestic licence application involves several layers of complexity, and detailed information and guidance on the process can be found on the gov.uk website: https://www.gov.uk/guidance/controlled-drugs-domestic-licences.

If you are distributing controlled drugs within Northern Ireland, then you will need a domestic licence from the Department of Health:
Controlled drugs | Department of Health (health-ni.gov.uk)

From now on, we will refer to the Home Office; if you are in Northern Ireland then you will need to take that into account.

Essentially, the domestic license application involves detailing to the Home Office the types of drugs you intend to possess (hold) and supply (distribute). The terms “possess”, and “supply” are ones you will commonly find on any Home Office license. The licensable activities and the authorisation granted depends on the schedule of controlled drug you intend to distribute and the controls you can demonstrate.

Please note, if you are a virtual distributor, you will still require a licence to possess and supply controlled substances as, while you may not physically hold these substances, they will be considered under your possession while under your ownership.

These schedules of controlled drugs, classified under the MDR 2001, categorise substances based on their potential for abuse and medical utility. The table below gives a summary of each schedule, and these should not be confused with classes of controlled drugs (i.e. class A, B, C) which are classified under the Misuse of Drugs Act 1971 and are common terms used by law enforcement agencies.

Note: The distinction between Schedule 4 Part 1 and Schedule 4 Part 2 lies in the stringency of controls, with Part 1 having more restrictions on substances like benzodiazepines compared to the relatively less restrictive controls in Part 2. A list of the most commonly encountered controlled drugs can be found here: https://www.gov.uk/government/publications/controlled-drugs-list–2

Please note, that should you wish to distribute cannabis-based products, detailed guidance has been provided by the MHRA on this matter here: https://assets.publishing.service.gov.uk/media/5e58eefb86650c53a363f77c/Cannabis_Guidance__unlicensed_CBPMs__updated_2020.pdf

In addition to considering the types of drugs you wish to distribute; you will also need to appoint a responsible officer within the application. This officer will oversee all controlled substances distributed under your domestic licence. Therefore, they should be trained and have a strong understanding of the requirements and prohibitions in distributing controlled substances. You will also be required to name a company director; ideally, this should be a different person than the responsible officer to ensure impartiality. Please note that any personnel named on the licence will be required to complete an enhanced DBS check.

Once the application is submitted, the Home Office will review it and correspond with you accordingly. They will expect you to have competent personnel and adequate processes in place for managing the distribution of controlled drugs safely and compliantly. They may wish to conduct a site visit if you are storing any medicinal products.

MHRA expectations and oversight

The MHRA will expect you to have extremely stringent control and oversight of any controlled substances sold under your WDA(H). Processes for qualifying your customers and suppliers of controlled drugs should be highly robust. It is essential to demonstrate that any suppliers or customers you deal with are authorised to possess these substances.

The MHRA will likely be interested in the quantities of controlled substances sold. Due to multiple incidents of misuse and diversion of controlled substances in the past, you will likely be required to justify sales of controlled drugs and monitor transactions.

It would be advisable to implement controls within your inventory management processes to ensure that there are limits to the quantities of controlled drugs sold to any particular customer and that the quantities sold are justified per their required use.

The press release below is one interesting example of how easily controlled drugs can be misused and abused, even in “legitimate” healthcare settings: https://www.gov.uk/government/news/regulator-investigating-the-diversion-of-prescription-only-medicines

Security of your supply chain

Security of your supply chain starts with on-site security, which should include restricted availability to trained and authorised personnel only. Controlled drugs should never sit freely on open shelving but in a dedicated and access-controlled storage location. CCTV monitoring is advisable. For schedule 1 and 2 substances, additional security will be required, such as bolted storage cabinets accessible only to trained personnel. These must meet Home Office specifications.

Security, however, is not just on-site but also within your distribution network. Once the products have left your site and are on their way to your customers, there is a risk of diversion and theft. It is imperative to consider such risks and implement controls to mitigate diversion within your chosen transport solution.

Exporting and global distribution

Exporting controlled substances to clients overseas involves an additional layer of complexity. Sales of controlled drugs across borders are monitored and communicated across nations, with each nation-state having its own classifications on controlled substances and regulations. There is a level of communication across nation-states with the International Narcotics Control Board (INCB), which assesses and promotes global adherence to international drug control standards. It maintains a relationship with national authorities, including the Home Office in the UK, as part of the broader international framework for regulating controlled substances.

If you wish to export controlled substances from the UK, you will require an additional export permit from the Home Office. You will also need to demonstrate evidence of permission to import the controlled substance to the desired overseas nation-state for such permits to be granted by the Home Office in the UK. Applications for export permits can be made online via the National controlled Drug System (NDS) portal in the UK, and you will be expected to clearly demonstrate controls and risk mitigation measures to prevent diversion and re-entry of any controlled substances back into the UK. The same system can also be used to import controlled substances or precursor chemicals into the UK. Depending on the type of substance you wish to import and its licensing status, this may require additional licensing from the MHRA under a Manufacturer/Importer License (MIA).

Please note, that should you wish to export or import controlled substances to/from Northern Ireland, you will still be required to apply for these permits with the UK Home Office as detailed here.

If you require further guidance on the type of licensing or permits you will require to export and/or import controlled substances, please get in touch, and SeerPharma UK will be happy to review your distribution model.

Reporting, annual returns, and renewals

It should be noted that domestic licence holders are expected to report all sales of controlled drugs in a particular year via the annual returns process. The Drugs and Firearms Licensing Unit (DFLU) will get in touch with your Responsible Officer to advise when such returns are due (typically by the end of January in a new calendar year for returns from the previous year). This includes all sales, exports, and even transactions for products supplied under third-party distributors. If you need assistance in understanding your controlled drugs sales and what would need to be reported, please get in touch, and SeerPharma UK will be happy to assist.

You should also note that domestic licenses granted are only valid for one calendar year. Thus, renewal applications need to be submitted annually. It is advisable to keep track of any license expiry dates, as renewal applications are not automatic and must be submitted manually. It would be wise to allow at least 6-8 weeks to submit a renewal application to prevent any gaps resulting in you not holding a controlled drugs licence.

Concluding remarks

Distributing controlled substances can be incredibly challenging, with additional security measures, oversight, and control expected, not to mention the high level of risk carried due to their potential for misuse or abuse. Increasing efforts to control who has access to these products and the quantities that can be purchased are simple yet effective steps to protect the integrity of the supply chain and prevent cases of diversion, misuse, and abuse.

SeerPharma UK’s consultants have direct experiences in managing controlled drugs, having worked directly with global distributors who supply controlled substances. Please reach out to us should you wish to seek a professional opinion and guidance on navigating this complex network.