The Pharmaceutical Journal
Vol 268 No 7199 p705-712
25 May 2002

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GSL status sought for Nizoral and Regaine products

Applications have been made to the Medicines Control Agency for the reclassification of Nizoral (ketoconazole) shampoo and Regaine (minoxidil) regular strength solution as general sale list medicines.

The applications are being made under the MCA's new simplified procedure (PJ, 4 May, p598). Under the new procedure, the legal category of a medicine is determined by the marketing authorisation of each product rather than by listing active substances in secondary legislation. As a result, the MCA says, there is no longer a need to consult publicly on each proposed change. However, interested parties are being given opportunities to comment.

Each application, or set of applications, will now have its own consultation period, normally lasting four to six weeks. They will be identified by the prefix ARM (application to reclassify a medicine).

ARM1, covering Nizoral and Regaine, runs until 1 July and has been published on the MCA's website (Microsoft Word document, 125K).