This section describes how a medicinal product is defined and how the MHRA determines whether a product falls within that definition, explains what borderline products are and gives an overview of the borderline legislation which came into force on 1 March 2000.
In this section...
What is a medicine?
Article 1 of Directive 2001/83/EC as amended defines a 'medicinal product' as:
“Any substance or combination of substances presented as having properties for treating or preventing disease in human beings;
Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.”
Contraceptives, for example, fall within the definition of a medicine because they interfere with normal bodily function. Appliances, instruments and devices, for example, heart pacemakers, are not classed as medicines and are controlled by a European Devices Directive by the Devices section of the MHRA.
Medicines come in a variety of pharmaceutical forms depending on the condition to be treated and the way in which this may be done. For example, solid dosage forms such as lozenges, pastilles, tablets and capsules can be designed to dissolve slowly in the mouth; or more rapidly in the stomach for better absorption or to pass through the stomach to dissolve lower in the gut; or to give controlled release of medicament throughout the gut. External forms of medication include lotions, creams, ointments, liniments and skin patches. Aerosols can provide medication topically to the lungs for the rapid relief of asthma; suitable drops can carry medicaments to the eyes, ears and nose. Specially designed solid dose forms such as pessaries and suppositories carry medication into the vagina and rectum. Injections may be used to introduce medication through the skin into the blood vessels or to subcutaneous tissues, muscles and other tissues in the body.
The purpose of these various forms of medication is to carry the active constituent (the drug) to the area where it is most needed and, in so doing to avoid, or keep to the minimum, any unwanted effects on other areas of the body.
What is a borderline product?
Most human medicines are clearly identifiable as such and are subject to EC marketing authorisation procedures. However, there are some products where it is not so easy to distinguish a medicine from, for example, cosmetics or food supplements. These are known as borderline products.
A product which is for use only as a toilet preparation, disinfectant, food or beverage is not normally regarded as a medicinal product, and, therefore, does not require a marketing authorisation before being sold in the UK. Similarly, dietary supplements, containing such familiar substances as vitamins, amino acids or minerals, are generally subject to food safety and food labelling legislation rather than medicines control.
However, should any of the above contain a pharmacologically active substance or make medicinal claims (claims to treat or prevent disease, or to interfere with the normal operation of a physiological function of the human body are regarded as medicinal). For example, a toothpaste would generally be considered as a cosmetic, but if it is marketed with claims to treat or prevent 'sensitive' teeth or it contains an active ingredient known to have such an effect then it would fall within the definition of a medicinal product and be subject to medicines control.
Bandages and other surgical dressings are not subject to the marketing authorisation procedures unless they are medicated and the curative effect of their medication is their primary purpose.
How the MHRA determines whether a product is medicinal
The MHRA's Borderline Section will offer advice on the status of a product in cases of doubt. In making a decision, the MHRA considers each individual product on its merits and any information which may have a bearing on the product's status, for example, the claims made for the product, the pharmacological properties of the ingredients, whether there are any similar licensed products on the market, and how it is presented to the public through labelling, packaging, promotional literature and advertisements. The MHRA's Guidance Note 8, 'A guide to what is a medicinal product' provides more detailed information and is intended for the guidance of companies who need to consider whether products they propose to place on the market are medicinal or not.
While it is not part of the Agency's statutory duty to give marketing advice we do offer general guidance, however this service is heavily subscribed and response times may be very long. We therefore recommend that you refer to our Guidance Note 8 - "A Guide to What is a Medicinal Product". In Appendix 2 you will find contact details for other organisation that may be able to assist you. If, after reading this and seeking advice from the recommended sources, you are still in need of our advice on the likely status of a product under medicines legislation please use our Borderline Advice Form.
Enquiries, including enquires about medical devices and the legislation which applies to medical devices should be made to 020 3080 6000.
An increasingly large number of products contain herbal ingredients. Because herbal ingredients can have many uses it may not always be clear whether the product containing them will fall within the definition of a medicinal product. Following consultation with a number of UK Trade Associations the Medicines Borderline Section has put together a guidance sheet on herbal ingredients (33Kb) which includes a list of herbal ingredients and their reported uses. (438Kb) The list is for information only, the status of a product under medicines legislation is determined on a individual basis taking into account all the factors detailed in Guidance Note 8.
The Medicines Borderline Section and the internet
Information on the Internet about a product and its uses is not excluded from the definition of the term 'advertising'. To help companies avoid bringing unlicensed products within the definition of a medicinal product the following guidance on the Internet may be helpful:
The Medicines Borderline Section and the Internet
On 1 March 2000, The Medicines for Human Use (Marketing Etc.) Amendment Regulations 2000 came into force. They make the way in which the MHRA determines whether a product is a medicinal product more systematic and transparent as well as improving the effectiveness of compliance and enforcement activity. The changes are:
- The MHRA will give full written reasons for its decisions.
- There is an Independent (Advisory) Review Panel which, on request, will consider written and oral representations against MHRA provisional classification determinations. Guidance on requesting a review of a Provisional Determination issued by the Borderline Section is available.
- There is an offence of non-compliance with final MHRA decisions.
This statutory procedure provides a safe regulatory environment in which safe and beneficial products are widely available, while ensuring that products sold illegally are promptly removed from the market. Guidance on the operation of the statutory process, in particular the Review Panel's procedures, has been issued. Trade associations contributed to its development and agreed its contents.
Background to borderline legislation
The UK was threatened with Infraction Proceedings at the European Court of Justice (ECJ) following the European Commission's 'Reasoned Opinion'; early in 1998 that it was not enforcing its decisions consistently and without delay. Consultation proposals (MLX249) were published on 6 November 1998 to make the classification process more transparent, open and 'fair', while improving the effectiveness of MHRA enforcement activity. Many industry and pressure group reactions were hostile. Apart from outright mis-representation of the proposals, criticisms were focused on: the alleged shortness of the consultation period (to 31 January 1999); the perceived lack of independence of the proposed review of Agency decisions; the new criminal offence of not complying with a final Agency decision; and the perceived difficulty a manufacturer would have, in court proceedings, in proving beyond reasonable doubt that his product was not a medicine.
Following advice from the MHRA and with the benefit of Counsel's Opinion, the Government announced changes to the proposals at an MHRA Open Day on 16 July 1999. The changes were:
- a demonstrably independent panel to review MHRA provisional decisions
- restoring to the MHRA the burden of proof in criminal proceedings for non-compliance with an MHRA final decision
- tequiring the MHRA to give full reasons for its provisional and final decisions
- the changes met the major criticisms of the original proposals while still enabling the licensing authority to protect public health, and satisfy the Commission that the UK is fulfilling its EC obligations.
The changes announced were generally well received by industry, consumer representatives, and the leading parliamentary critics. The draft Guidance on how the Independent Review Panel would work was discussed and agreed with trade association leaders. Interested organisations were invited to nominate to the Review Panel on 17 December and over 50 nominations were received. The new legislation was laid before Parliament on 9 February 2000 and came into force on 1 March 2000.