Advisory Committee on Borderline Substances

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In the UK, as in the rest of the EC, medicinal products which are placed on the market, are required to have marketing authorisations (formerly product licences) in accordance with The Medicines for Human Use (Marketing Authorisations) Regulations 1994 (S.I.1994/3144). Amongst other things these provide that, unless exempt, no medicinal product shall be placed on the market unless a marketing authorisation has been granted in accordance with Community provisions by the licensing authority or the European Commission. It is an offence to sell or supply or to advertise a medicinal product which does not have a marketing authorisation.

Article 1 of Directive 2001/83/EC defines a “medicinal product” as:

(a) “Any substance or combination of substances presented as having properties for treating or preventing disease in human beings;

(b) 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”

In practice, in coming to a view about any product, the Agency considers all the characteristics of the individual product and any information which may have a bearing on the product's status. A product may be viewed as a medicinal product because of the way in which it is presented. The Agency also considers the effect the product has on human physiology. If it satisfies one or both of the criteria, it is classed as a medicine. A product presented as a nutritional substance or cosmetic may still be a medicinal product if it contains ingredients which have a significant pharmacological effect.

When considering the classification of products that are to be submitted to Advisory Committee on Borderline Substances (ACBS) the MHRA applies the same criteria as it would to all products. For further information please refer to our Guidance Note 8 "A Guide to What is a Medicinal Product". (225Kb)

To enable us to consider the classification for your product we require hard copies of the following:

  • A cover letter stating that you will be submitting your product to the next ACBS meeting
  • Full details of the ingredients including quantities for each
  • Copies of the packaging, information leaflets and promotional material

Please send the information to:

Borderline Section
Market Towers
1 Nine Elms Lane
London SW8 5VQ

In respect of ACBS products we acknowledge that it may be appropriate to provide additional information to qualified healthcare professionals. If you need to include this for your product please confirm that this information will not be available direct to the public.

As we receive high volumes of request in respect of ACBS, please ensure we receive details of your application at least three weeks prior to the deadline for ACBS. This will allow time for you to make any necessary changes to meet requirements.

The issue of a letter from MHRA in respect of your application to ACBS does not mean that your product will be acceptable to the Advisory Committee on Borderline Substances (ACBS) for reimbursement at NHS expense. A copy of our letter and all the material you submitted to the MHRA will be sent to ACBS for their information.

Information on ACBS, including the dates for this years scheduled meetings, is available at Purchasing and Supply Agency (PASA) (external link).


Page last modified: 19 March 2008