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Independent Review Panel on the Classification of Borderline Products

The MHRA consulted on its proposals to amend the Medicines for Human Use (Marketing Authorisations etc.) Regulations 1994, and introduce a statutory procedure for classifying borderline medicinal products, in November 1998. As a result of the response to the proposals, Lady Hayman announced significant changes to those proposals on 15 July 2000. The changes announced included an undertaking that the statutory panel to review the MHRA's provisional determinations will be independent of the MHRA.

Terms of reference
The functions of the Review Panel will be:

  • To consider written and oral representations from companies against a provisional determination by the MHRA, on behalf of the Licensing Authority, that a product is a medicinal product.
  • To advise the Licensing Authority whether or not the MHRA's provisional determination should be confirmed.
     Introduction


What the Panel will do
The Panel will be appointed by the Licensing Authority and will:

  • Consider written and oral representations from persons or companies against provisional determinations by the MHRA (Medicines), on behalf of the Licensing Authority (Health Ministers), that products are medicinal products.
  • Advise the Licensing Authority on whether the products are, or are not, medical products as defined in legislation.

Meetings
Meetings will be held in London at the MHRA (Medicines), Market Towers, 1 Nine Elms Lane, London SW8 5NQ. The frequency and duration of the meetings will initially be flexible according to demand.

Code of Practice
Papers and proceedings will be confidential to protect commercially sensitive information, but the Panel's advice will be published. Members will be required to follow a Code of Practice, which amongst other things will stipulate declarations of interest at meetings and withdrawal from discussion of cases where an interest might influence a member's contribution to the discussion. Member's interests will be published annually.

Membership
Members will not represent organisations, but will contribute by their individual expertise, experience and judgement to the Panel's advice to the licensing authority on the classification of products. Two to four members selected for their experience, expertise and interest in their relevant issues will support the Chairperson, who will be legally qualified. A list of the members is attached here.

Person specialisms
The following range of experience is needed by the Panel to fulfil its functions:

  • Legally qualified Chairperson.
  • The practice of human medicine or pharmacy.
  • Herbal or other branch of complementary medicine.
  • Nutritional therapy and food science.
  • The cosmetics industry.
  • Public health and consumer affairs.

Role of members
To attend, if possible, all meetings of the Independent Review Panel to which they are invited.
To consider, comment and contribute by their individual expertise and judgement as appropriate on agenda items, and to assist the Panel in framing suitable advice to the Licensing Authority on whether a product is a medicinal product.

Criteria for appointment
The Chairperson will be recognised by his/her peers as having a wide and recent experience of, and shown capacity in, the law, with particular reference to medicines.

A member of the panel will be recognised by his/her peers as an eminent member of their profession or calling and have a wide and recent experience of, and shown capacity in, at least one of the following activities:

  • The practice of human medicine or pharmacy.
  • Herbal or other branch of complementary medicine.
  • Nutritional therapy and food science.
  • The cosmetics industry.
  • Public health and consumer affairs.

Independent Review Panel on the Classification of Borderline Products Secretariat
The Secretariat of the Independent Review Panel on the Classification of Borderline Products is based at the MHRA and the list of members is as follows:

Mr Leslie Whitbread (Manager)
Mrs Fran Queen (Secretary)

Contacts for further information
For further information about this part of the site, please contact Mrs Fran Queen (Secretary), telephone 020 7084 3723. MHRA, Market Towers, 1 Nine Elms Lane, London SW8 5NQ, fax 020 7084 2493 or e-mail info@mhra.gsi.gov.uk
 

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Page last modified: 15 August 2006