Prescription medications FAQs
How are medicines approved?
The Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency responsible for ensuring that medicines and medical devices work and are acceptably safe. It monitors all medicines and devices and takes prompt action to protect the public if risks are identified.
How can I find out if my medicine is approved?
All pharmaceutical manufacturers must be able to prove that the manufacture, distribution and supply of a medicine meet the legally required safety and quality standards. If the MHRA is satisfied that a medicine is acceptably safe and effective, it will issue a marketing authorisation and product licence. The Medicines Act of 1968 provides the legal framework for the control of medicines in the UK and requires medicines to be licensed before being allowed onto the UK market.
Most new medicines (containing new active ingredients) are licensed by the European Medicines Agency (EMEA) to ensure standardisation across all member states of the European Union (EU).
How can I find out about side effects or safety concerns for my medicine?
Firstly, read the patient information leaflet as this documents all reported concerns and side effects. The MHRA strictly regulates medicines and medical devices for their safety and have the authority to remove any product from the market if risks are identified and to prosecute manufacturers if need be.
The MHRA will send warnings about defective medicines or serious side effects to healthcare professionals and organisations and will publicise findings, if appropriate, on the MHRA website.
If you have concerns about the side effects of medications that have been prescribed to you, consult your GP or pharmacist, who will be able to explain any safety concerns you may have.
Do all medicines have risks?
All medicines have risks and nothing is 100% safe. The MHRA will assess whether the risks from taking a medicine outweigh the benefits the patient will receive. The MHRA will also assess if the side effects are acceptable and if the medicine does the most good for the least harm for most people who will be taking it.
How do I report a suspected medicine side effect?
The Yellow Card scheme is a reporting system for side effects related to medicines and is managed by the MHRA. It is open to anyone to report side effects, whether it's for something you have experienced or on behalf of a child or adult in your care. Over the last 40 years approximately half a million reports have been received. The MHRA investigates if appropriate. Some have resulted in medications being re-classified or being removed from the market.
The Yellow Card scheme contains reports on prescription medicines, herbal medicinal products and over-the-counter medicines.
If you want to report a side effect contact your GP, pharmacist or visit yellowcard.mhra.gov.uk