Policy responses and statements

Name of organisation:

Medicines and Healthcare Products Regulatory Agency (MHRA)

Name of policy document:

ARM 50: Request to reclassify Nicorette Inhalator from Pharmacy (P) to General Sale List (GSL)

Deadline for response:

15 January 2008

Background: Consultation ARM 50 sought views on the reclassification of Nicorette Inhalator (PL 00032/0280) from Pharmacy (P) to General Sale List (GSL). Nicorette Inhalator is indicated for the relief of nicotine withdrawal symptoms as an aid to smoking cessation in adults and children over 12 years of age. In smokers currently unable or not ready to stop smoking abruptly, the inhalator may also be used as part of a programme to reduce smoking prior to stopping completely.

COMMENTS ON
MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA)
ARM 50 - REQUEST TO RECLASSIFY NICORETTE INHALATOR FROM PHARMACY (P) TO GENERAL SALE LIST (GSL)

The Royal College of Physicians of Edinburgh is pleased to respond to the Medicines and Healthcare Products Regulatory Agency on consultation ARM 50.  ARM 50 is a company application to reclassify Nicorette Inhalator from P to GSL.

The present situation is that all other forms of Nicotine Replacement Therapy (NRT) are already GSL.  Their safety profile and abuse potential are well documented and are considered to be satisfactory in comparison with the risks of smoking.  The safety profile and abuse potential of the Inhalator are not significantly different from the other NRT formats.

The patient product information is clear and specific, and will contain agreed additional information regarding pregnancy and the benefits of consulting health care professionals.  The application was supported by the Commission on Human Medicines with the proviso that additional conditions should be added regarding contraindication in children under 12 years of age, the dangers to children if they attempt to swallow or suck the cartridge and its unsuitability in patients with lung disease.  With these amendments, the College is pleased to support this proposal.

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

[19 December 2007]