Project Covima: A reclassification application to widen access to a medicine that enables pharmacy to support a major public health need, where services are massively disrupted by C19, with significant societal impact

*帮助药剂师填补由于covid - 19大流行造成的避孕服务空白，在这种情况下，全科医生和性健康诊所的服务严重中断，一些服务完全暂停。C19对胎儿的影响目前尚不清楚。*麦克斯韦利亚的目标是提交一份重新分类申请，以扩大口服避孕药的使用范围，使女性无需医生处方就可以在药店购买。这包括：1；现实可行的药房供应模式设计从合同生产商处获得合适的上市许可。设计和准备药品重新分类申请的关键成分。向英国监管机构（MHRA）提交药物重新分类申请5。解决MHRA关注的问题以克服它们。管理过程直至成功结束。*这将使更多的女性更容易获得避孕服务和省钱NHS的潜在减少所需的医生预约服务发布的330万年处方为这种类型的药物成本估计为每年£99 m。*项目Covima将有助于减少意外怀孕目前成本NHS每年£240,将由于C19上升,婴儿潮(coronials)是C19预测结果,这进一步增加了NHS的压力，从而增加了国家的成本。-额外信息-影响资金的延长将允许Maxwellia进行一项研究，审查Maxwellia第一款避孕产品在药房的成功和可接受性，以及药房培训材料的有效性，以支持MHRA重新分类申请。

* Helping pharmacists to plug the void in contraceptive services that has resulted as an outcome of the C19 pandemic where access to GP's and sexual health clinics has been severely disrupted with some services suspended altogether. The effect of C19 on the unborn child is currently unknown.* Maxwellia aims to submit a reclassification application to widen access to an oral contraceptive pill to make it available for women to buy in a pharmacy without the need for a doctor's prescription.* This involves:1. The design of a realistic and deliverable pharmacy supply model2. Procurement of a suitable marketing authorisation from a contract manufacturer3. Designing and preparing the key components of the reclassification application for the drug4. Submitting the application to reclassify the drug to the UK regulator (MHRA)5. Addressing MHRA concerns to overcome them6. Managing the process to its successful conclusion.* This will enable more women to access contraceptive services more easily and save money for the NHS by potentially reducing the GP appointments needed to service the 3.3 million prescriptions that are issued for this type of drug each year at an estimated cost of £99m.* Project Covima will help reduce unplanned pregnancy which currently costs the NHS £240m per annum and is set to rise due to C19 where a baby boom (the coronials) is predicted as a result of C19, adding further pressure to the NHS with resultant increased costs for the nation.-Additional information - The extension for impact funding will allow Maxwellia to conduct a study reviewing the success and acceptability of Maxwellia’s first contraceptive product in pharmacy and the effectiveness of the pharmacy training materials to support the MHRA reclassification application.