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In the United Kingdom, what is commonly termed "FDA Law" elsewhere is more accurately governed by the regulatory framework surrounding medicines, medical devices, and food safety. While there is no agency called the FDA in the United Kingdom, the relevant authority is the Medicines and Healthcare products Regulatory Agency (MHRA). Certain responsibilities also fall under the Food Standards Agency (FSA). These bodies are responsible for licensing, monitoring, and regulating products to ensure public health, safety, and consumer protection. The UK regulatory system is robust and is designed to guarantee that medicines, foods, and medical devices meet strict safety, efficacy, and quality standards before they reach the market.
Navigating the legal landscape of medical, pharmaceutical, and food regulations can be complex. People may require legal help in the following situations:
The UK has a comprehensive legal structure that governs the regulation of medicines, medical devices, and food. Some of the key legislative frameworks include:
Compliance with these laws is mandatory for manufacturers, distributors, importers, retailers, and healthcare providers.
The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK's authority responsible for regulating medicines, medical devices, and blood components. It evaluates the safety, quality, and efficacy of these products before they are marketed.
No, products approved by the US FDA must separately be authorised by the MHRA or, for certain products, comply with relevant UK and European standards before being marketed in the UK.
A company must apply to the MHRA and provide comprehensive data on the medicine's safety, efficacy, and quality. Approval is only granted after rigorous review and is mandatory before any product can be lawfully marketed.
Penalties can include product recalls, fines, criminal prosecution, suspension or withdrawal of product licences, or being banned from supplying certain products.
Medical devices must meet the requirements set by the Medicines and Medical Devices Act 2021 and must be marked with the UKCA mark. Higher risk devices must undergo conformity assessment by an approved body.
The Food Standards Agency (FSA), along with local authorities, monitors compliance with food safety and labeling laws in the UK.
No, most dietary supplements are regulated as foods, but some may fall under special rules if they claim medicinal properties or contain certain ingredients.
Advertising prescription-only medicines directly to the public is prohibited. Over-the-counter medicines can be advertised, but there are strict rules governing the content and claims made in such advertising.
Brexit has resulted in the UK developing its own regulatory system for medicines and medical devices, meaning companies must comply with both UK and, if exporting, EU rules.
It is important to seek legal advice promptly. You should respond in a timely and cooperative manner while ensuring you understand your rights and obligations.
If you need more information or guidance on regulatory matters, these organisations and resources can be helpful:
If you need legal assistance relating to MHRA or FSA regulation, start by clearly identifying your issue, gathering all relevant documentation, and researching potential solicitors or law firms with expertise in medicines, medical device, or food law. Arrange a consultation to discuss your situation and options. Being proactive and well-prepared can help you resolve regulatory concerns efficiently and protect your business or personal interests. If you have received communication from a UK regulator, act quickly and seek professional advice to avoid escalation or penalties.
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