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

*帮助药剂师填补避孕服务空白，这是C19大流行造成的结果，在C19大流行中，全科医生和性健康诊所的准入严重中断，一些服务完全暂停。C19对未出生婴儿的影响目前尚不清楚。*Maxwell的目标是提交一份重新分类申请，扩大获得口服避孕药的机会，使妇女无需医生处方就能在药房购买。*这涉及：1.设计一种现实和可交付的药房供应模式2.从合同制造商处采购合适的营销授权3。设计和准备药品重新分类申请的关键组件4.向英国监管机构(MHRA)提交药物重新分类的申请5.解决MHRA的担忧以克服它们6.管理这一过程直至成功结束。*这将使更多的妇女更容易获得避孕服务，并通过潜在地减少为这类药物每年开出的330万张处方提供服务所需的全科医生预约，从而为NHS节省资金。*Covima项目将有助于减少意外怀孕，目前NHS每年花费2.4亿GB，由于C19预计将出现婴儿潮(冠冕)，意外怀孕将会增加。给国民健康保险制度增加了进一步的压力，从而增加了国家的成本。-更多信息--Impact资金的延长将使Maxwell lia能够进行一项研究，审查Maxwell lia的第一种避孕产品在药房的成功和可接受性，以及支持MHRA重新分类申请的药房培训材料的有效性。

* 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.