Policy responses and statements

Name of organisation:

Medicines and Healthcare Products Regulatory Agency

Name of policy document:

ARM 35: Request to Reclassify a Product from POM to P
[Fenistil Cold Sore Cream]

Deadline for response:

28 February 2006

Background: The MHRA has launched Consultation document ARM 35, which includes the applicant’s Reclassification Summary and Patient Information Leaflet. The consultation sought views on the reclassification from POM to P of Fenistil Cold Sore Cream. Fenistil Cold Sore Cream is indicated for the treatment of cold sores (herpes labialis).

Mr Ian Martin
Reclassification Manager
Medicines and Healthcare Products
Regulatory Agency
Market Towers
1 Nine Elms Lane
LONDON SW8 5NQ

Dear Mr Martin

ARM 35: REQUEST TO RECLASSIFY A PRODUCT FROM POM TO P - FENISTIL COLD SORE CREAM

The Royal College of Physicians of Edinburgh is pleased to respond to the MHRA on its consultation ARM 35: Request to Reclassify a Product from POM to P relating to Fenistil Cold Sore Cream.

This application is for the drug to be classified as available for pharmacists without prescription. This seems entirely reasonable and sensible, and the College therefore agrees with the proposal to reclassify this product.

Yours sincerely

John S A Collins MD FRCP Edin
Secretary

Copies of this response are available from:

Lesley Lockhart,
Royal College of Physicians of Edinburgh,
9 Queen Street,
Edinburgh,
EH2 1JQ.

Tel: 0131 225 7324    ext 608
Fax: 0131 220 3939

[28 February 2006]