§ Mr. GummerTo ask the Secretary of State for Health what plans he has to frame the proposed re-classification of levonorgestrel 0.7 mg as an over the counter product so that it does not contravene Section 58A of the Medicines Act 1968 in relation to its side-effects; and if he will make a statement. [138893]
§ Ms StuartThe proposals to widen availability of emergency contraception follow an application to reclassify levonorgestrel 0.75 mg for emergency contraception from prescription only to pharmacy availability for women aged 16 years and over. The application was referred for independent expert advice to the Committee on Safety of Medicines (CSM). In formulating their advice, the CSM carefully considered each of the relevant criteria for prescription control laid down in Section 58A of the Medicines Act 1968. The Committee concluded that all the steps required to supply safely emergency contraception could be successfully completed in a pharmacy and advised that levonorgestrel 0.75 mg for emergency contraception may safely be supplied as a pharmacy medicine for women aged 16 and above. The Committee noted that information on correct use would be provided with the product including any possible side effects and advice on what action to take.
The results of a public consultation on the proposal, and the advice of the Medicines Commission, were presented to Ministers for a decision. If we decide to proceed with the reclassification, an Order will be laid before the House shortly.