Medicines Healthcare Products Regulatory Agency
Some products are hard to distinguish from medicines, for example products that might be medical devices, cosmetics, food supplements or biocidal products. These products are called borderline products until their status has been decided.
The MHRA determines whether a product falls within the definition of a medicinal product and provides information on whether a product is a medicine or not. The MHRA also determines whether a product is a medical device or not.
Types of borderline products
The types of products which may fall into the borderline category include:
- cosmetics
- food products, including, in particular, food supplements
- herbal products
- biocides
- machinery/laboratory equipment
There is also a borderline between medicinal products and medical devices, both of which have medical purposes. In these cases, it will be the claims being made and the mode of action that will decide which regulatory regime will apply (medicine or device).
Medicines borderline
A medicinal product is:
- any substance or combination of substances presented as having properties of preventing or treating disease in human beings
- any substance or combination of substances that may be used by or administered to human beings with a view to restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic action, or making a medical diagnosis
Disease is defined in Regulation 8 of The Human Medicines Regulations 2012 as includes any injury, ailment or adverse condition, whether of body or mind.
Find more detailed information in Regulation 2 of the Human Medicines Regulations.
Food supplements that contain familiar substances like vitamins, amino acids or minerals are generally subject to food safety and food labelling legislation rather than medicines control unless presented for medicinal uses. You can get advice on food and cosmetics from the Trading Standards Institute. The MHRA decides whether the claims that are made or the active substance(s) present mean that a product should be regarded to be a medicinal product.
The inclusion of herbal or natural ingredients does not exclude a product from being a medicinal product. The MHRA takes the same factors into account when deciding the status of a product with herbal ingredients as any other product.
How we decide if a product is a medicine
The MHRA decides whether a product is a medicine when:
- the manufacturer or product seller is not sure if their product is a medicine or not, and they come to the MHRA for advice
- the MHRA receives a complaint that a product is being marketed as a medicine but does not have an appropriate marketing authorisation
We look at:
- the claims about what the product does (explicit and implicit)
- the pharmacological, metabolic or immunological properties of the ingredients (this includes any herbal ingredients)
- the primary intended purpose of the product or the manner in which it would be used by consumers
- whether there are any similar licensed or registered products on the market
- how it is presented to the public through labelling, packaging, promotional literature, advertisements, websites, social media and customer reviews
See final determinations by the MHRA on borderline products - March 2018.
See final determinations by the MHRA on borderline products - October 2010 to July 2014.
Previous final determinations are available on the National Archives.
See .
Complaints
All referrals and complaints about potential breaches of The Human Medicines Regulations 2012 are reviewed and dealt with by the MHRA. As we receive a high volume of referrals, it is necessary to consider them on the basis of priority, the highest of which is where there is a perceivable risk to the health and safety of consumers. As a consequence, it is not possible to take immediate action in all cases.
In the majority of cases we aim to resolve issues through voluntary compliance by the relevant company. It cannot be assumed that a product found to be in breach of medicines regulations will always be removed from sale as a result of our action. In some cases, issues can be resolved by amending product details such as claims or product formulations.
Generally, investigations need to be conducted with commercial confidentiality in mind and for that reason, it is not always possible for us to provide feedback on cases. It is also not possible to say how long investigations will take to reach a conclusion as this is dependent on a number of factors, several of which can delay progress. This will apply in particular where voluntary compliance is not achieved, or where investigations need to be escalated to a position of potential prosecution. Although it may appear that nothing is being done, this is not the case. In such circumstances, there is a risk that cases could be prejudiced by disclosures.
In some instances, the MHRA receives referrals about products that are not deemed to be in breach of medicines regulations, or which may be more appropriately dealt with by another authority such as Trading Standards. This may be where more than one set of regulations is being breached. We will either recommend the referrer contacts the appropriate authority themselves, or in some circumstances, may forward the complaint on their behalf. The MHRA will not be able to chase up referrals on behalf of a third party where they have been forwarded to another authority.
The MHRA has authority to administer and enforce regulations relating to medicinal products that are sold, supplied or advertised from within the UK. Products that are sold, supplied or advertised by non-UK companies from outside of the UK and exported directly to consumers in the UK are investigated, but may fall outside of the MHRAs legal jurisdiction.
Getting advice about your product
You can find detailed advice here in our guide to what is a medicinal product. You should read this document before contacting the MHRA.
You can obtain a regulatory opinion on the status of a product you are planning to sell in the UK by providing the appropriate details using the Medicines Borderline Advice Form. The MHRA will normally only respond to a maximum of 4 product enquiries from the same person.
If your enquiry is about the regulatory route for a medical device you should review our guidance on how to tell if your products is a medical device. If you require additional guidance you may email Devices.Borderlines@mhra.gov.uk including full details of the product, its intended purpose and how it works.