What is a medicine/borderline product? UK

Main Category: Public Health
Article Date: 14 Jun 2004 - 16:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

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 MEDICINES HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA) OF THE UK 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.

BORDERLINE LEGISLATION

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:

(i) The MHRA will give full written reasons for its decisions.

(ii) There is an Independent (Advisory) Review Panel which, on request, will consider written and oral representations against MHRA provisional classification determinations.

(iii) 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.

-- Requiring 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 will 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 have been received. The new legislation was laid before Parliament on 9 February 2000 and came into force on 1 March 2000.

Contact for further information

For further information on this part of our site, please contact our Borderline Section, 16-1, MHRA, Market Towers, 1 Nine Elms Lane, London SW8 5NQ, telephone 020-7084 2759, fax 020-7084 2439 or e-mail info@mhra.gsi.gov.uk