Licensing of medicines
Licensing of medicines
By law, before a medicine can be prescribed by a doctor it must be given a product licence (or ‘marketing authorisation’) by a regulator. In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) is the regulator. The licensing system shows patients that people involved in making the medicines are responsible for their actions, that someone independent watches over the process, and that - when needed - fast action will put things right.
Before granting a licence the MHRA will want to know:
- What impact a medicine will have on patients’ quality and length of life
- If the evidence backs up how the product is used
- If all the information about the known and expected side effects has been made available.
When the MHRA is satisfied that the medicine meets high standards of safety and quality, and that it works for the condition it is supposed to treat, the licence is granted. In the UK a product licence is shown as a PL number (PL XXXXX/YYYY) – you can find this on the medicine box.
The MHRA continues to monitor the safety and effectiveness of all medicines after they are licensed. One way it does this is through the yellow card system for reporting side-effects at https://yellowcard.mhra.gov.uk/ The MHRA can take a medicine off the market if there are worries about its side effects, or whether it works as it should do.
“Off-label” or “Unlicensed” use
Sometimes doctors find that a licensed medicine will work for a condition, for age-groups, or at a dose for which it has not been licensed. The doctor will prescribe the medicine based on their own and other doctors’ experience, published research studies, and findings presented at professional meetings. This is called “off-label” prescribing. This can happen when there are no other medicines licensed, or where access to other effective medicines is restricted. This can definitely happen when treating young people, as very few medicines are licensed for use in patients less than 18 years old.
Sometimes there are no suitable medicines available. In these circumstances the prescribing doctor might ask the pharmacist to make up a medicine especially for a particular patient, or even ask the MHRA to allow the pharmacist to import a medicine from another country for a “named” patient. This is called “un-licensed” prescribing.
More information on the licensing process and what the MHRA does is available from the MHRA website.