Question to the Department of Health and Social Care:

To ask Her Majesty's Government what discussions they have had with the Medicines and Healthcare products Regulatory Agency about licensing the polypill in the absence of applications by pharmaceutical companies.

There have not been any recent meetings with the Medicines and Healthcare products Regulatory Agency (MHRA) about licensing the polypill in the absence of applications from pharmaceutical companies.

The MHRA is only able to grant a marketing authorisation once the legislative requirements for placing on the market of the product are fulfilled. Prior to approval, the marketing authorisation holder will need to generate and provide adequate evidence of quality, safety and efficacy for the product in a particular group of people (indication). In the absence of a marketing authorisation holder, an application seeking the licence, or data supporting the product, the MHRA is unable to authorise any product. Moreover, the MHRA is not able to compel any sponsor to make an application. The MHRA has over the years contributed to the European guideline, supporting the development of such combination products and has provided scientific advice to companies to facilitate development of polypill product.