Policy responses and statements

Name of organisation:

Medicines and Healthcare Products Regulatory Agency (MHRA)

Name of policy document:

ARM 36 - Request to Reclassify a Product from P to GSL - Galpharm Hayfever and Allergy Relief

Deadline for response:

12 December 2006

Background: Consultation Letter ARM 36 seeks views on a proposal to reclassify Galpharm Hayfever and Allergy Relief from P to GSL.

Name: Galpharm Hayfever and Allergy Relief PL 16028/0067

Active: Cetirizine Hydrochloride 10mg

Indications: Cetirizine is indicated for the symptomatic treatment of perennial rhinitis, seasonal allergic rhinitis and chronic idiopathic urticaria in adults and children aged 6 years and over.

COMMENTS ON
MEDICINE AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA) ARM 36 - REQUEST TO RECLASSIFY A PRODUCT FROM P TO GSL - GALPHARM HAYFEVER AND ALLERGY RELIEF

The Royal College of Physicians of Edinburgh is pleased to respond to the MHRA on ARM 36 - Request to Reclassify a Product from P to GSL - Galpharm Hayfever and Allergy Relief.

Galpharm Hayfever and Allergy Relief appears to have been on general sale since April 2002 and more recently to children of 6 years of age and above. The present proposal seems to be that people would be able to buy 14 tablets in a pack instead of 7.  Given that this is a relatively non-sedating antihistamine with good safety data available for both P and GSL sales, this proposal seems to be entirely non controversial, and the College would therefore support it.

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

[21 November 2006]