When it comes to medicines, understanding the difference between licensed and unlicensed products is vital for both healthcare professionals and patients. This is especially true in sectors such as medical cannabis, where unlicensed medicines—often supplied as “specials”—play a significant role. But if you encounter an issue with an unlicensed product, who do you turn to? This guide will walk you through the key points, clarify which organisations to contact, and explain the roles of dispensing pharmacies, prescribing clinics, and authorised manufacturers in maintaining safety.
Understanding Licensed vs Unlicensed Medicines
The medicines you use fall into broadly two categories: licensed and unlicensed.
- Licensed medicines have passed rigorous assessment and approval by the relevant regulator. In the UK, this is the Medicines and Healthcare products Regulatory Agency (MHRA). Licensed medicines come with a summary of product characteristics (SmPC), standard dosages, and safety data. Unlicensed medicines have not undergone the full licensing process. These may be “specials” made for named patients when no suitable licensed alternative is available. This pathway allows access to medicines tailored to individual needs but carries additional responsibilities for supply and safety oversight.
It’s important to note that “unlicensed” does not mean illegal. The supply of unlicensed medicines follows strict regulatory frameworks designed to protect patients.
The Named-Patient Unlicensed Specials Pathway
In the UK, unlicensed medicines are often provided under the “named-patient” specials scheme. This means they are prescribed by a clinician for an individual patient, often when:
- A licensed medicine is unavailable or unsuitable A specific formulation is needed, e.g., a liquid form for a child A novel treatment under clinical consideration, such as some cannabis-based products
Named-patient specials are typically sourced from an authorised pharmacy or manufacturer, who keeps detailed batch and supply records for safety and traceability.
Role of Specialist Prescribing and Private Clinics
Specialist prescribing units and private clinics, such as medicalcannabis.co.uk or the Releaf cannabis clinic, often facilitate access to unlicensed cannabis-based medicines. These providers operate under strict governance, ensuring appropriate clinical assessment before prescribing.
- Patients usually undergo thorough evaluation to ensure safety and suitability The clinic acts as the prescribing clinic and can guide patients on supply options Dispensing pharmacies work closely with these clinics to provide the correct medicine in line with batch records
Authorised Manufacturers and Importers
Unlicensed specials are generally prepared or imported by authorised parties. These manufacturers and importers:
- are regulated by the MHRA to ensure quality and safety standards maintain batch and supply records that enable traceability if any issues arise must comply with Good Manufacturing Practice (GMP)
Because unlicensed medicines do not have a product licence, the responsibility for pharmacovigilance—monitoring adverse effects—and reporting falls on the prescriber, the dispensing pharmacy, and the manufacturer/importer together.
If There Is an Issue With an Unlicensed Product, Who Do I Contact?
If you are a healthcare professional or patient and suspect a problem with an unlicensed medicine, here are the recommended steps:
1. Contact the Dispensing Pharmacy
The dispensing pharmacy is often the first point of contact. Pharmacies keep detailed batch and supply records and can provide information on the product supplied. They can also coordinate with the manufacturer or importer for investigation.
2. Contact the Prescribing Clinic
If the medicine was prescribed by a specialist clinic (such as the Releaf or medicalcannabis.co.uk clinics), informing them is essential. They can:
- Review the patient’s clinical status Report issues to the appropriate authorities Advise on immediate steps, including alternative treatments if necessary
3. Notify the Manufacturer or Importer
Manufacturer/importers authorised by the MHRA are required to investigate any complaints or adverse reactions related to their products. Contact details will usually be provided with the medicine or via the dispensing pharmacy.
4. Report to the MHRA
The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK government agency that regulates medicines https://pharma-journal.com/uk-medical-cannabis-supply-chain-unlicensed-medicines and devices. They operate a Yellow Card Scheme, which is the official system for reporting adverse drug reactions, including those related to unlicensed medicines.
You can report issues online via the Yellow Card website or through healthcare professionals.
Helpful Tools and Resources
For healthcare professionals wanting to stay updated or report concerns confidently, the Pharma Journal offers a ‘Listen’ audio option that provides summaries of regulatory updates and practical guidance. This can be convenient during busy clinical sessions.
If you wish to receive detailed updates or guidelines regarding supply chain compliance, authorised manufacturing status, or prescribing advice for unlicensed specials, subscribing via the Site Subscription Form of specialist journals or regulatory bodies is recommended.
Summary Table: Who to Contact If There Is an Issue with an Unlicensed Medicine
Entity Role Contact Point What to Expect Dispensing Pharmacy Supplies medicine; holds batch and supply records Pharmacy customer service, pharmacist Information on batch; coordinate investigations Prescribing Clinic (e.g., Releaf, medicalcannabis.co.uk) Prescribes; clinical oversight Clinic helpline or admin desk Clinical review; report to MHRA if needed Manufacturer/Importer Quality control; batch traceability Contact info on medicine label or supply note Investigate complaints; report to regulator MHRA Regulator; adverse event monitoring Yellow Card Scheme Receive and assess reports; regulatory actionsFinal Thoughts
Dealing with unlicensed medicines requires awareness of the supply chain and the roles of different organisations. Dispensing pharmacies and prescribing clinics maintain batch and supply records essential for tracing issues. Authorised manufacturers and importers are regulated by the MHRA to ensure quality. When problems occur, clear communication with these trusted parties is the safest way forward.
If you want to keep up with the latest insights on unlicensed specials, consider listening to Pharma Journal’s ‘Listen’ audio option or subscribing to specialist regulatory updates via their site subscription form. Understanding the pathways for unlicensed medicines ensures patient safety and confidence in treatments where licensed options are unavailable.