PJ Online | News: Legal reclassifications sought
The Pharmaceutical Journal
Legal reclassifications sought
VIEWS on the reclassification of Grisol 1 per cent spray (griseofulvin) for the topical treatment of fungal infections and Hc45 bite and sting relief cream (1 per cent hydrocortisone) are being sought by the Medicines Control Agency.
Grisol is a prescription medicine which the manufacturer (Transdermal) wants to be available from pharmacies and Hc45 is a pharmacy medicine which Crookes wants to be available on general sale. So far as Grisol is concerned, the MCA says that the safety of griseofulvin has been established for many years and that the topical use of the product raises no new safety concerns, particularly with respect to acquired resistance or percutaneous absorption.
The MCA view on the reclassification of Hc45 is that there are no safety issues, provided the product's labels and leaflets give clear advice about its correct use. However, it wants the name changed to Hc45 bite and sting relief cream to avoid confusion with E45.
Consultation on both reclassification applications runs until 30 September 2002. Comments can be sent to Amanda Lawrence, Reclassifications Manager, Medicines Control Agency, Room 14-152 Market Towers, 1 Nine Elms Lane, London SW8 5NQ.
Citation: The Pharmaceutical Journal URI: 20007518