. UK MHRA Suggests Little Changes to Regulatory Framework

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UK MHRA Suggests Little Changes to Regulatory Framework

The MHRA (Medicines and Healthcare products Regulatory Agency, UK) has released letter on the negotiations between the EU and the UK which have now in second phase.

Guidelines for collaboration between UK and Union were adopted in December 2017 which mainly contains transition plans and the framework for the future relationship. Report was built to explain how the “goods placed on the market under Union law before the withdrawal date may freely circulate on the markets of the UK and the Union with no need for product modifications or re-labelling; be put into service where provided in Union law, and that the goods concerned should be subject to continued oversight.”

Meanwhile, the EU guidelines acknowledged the proposal put forward by the UK for a definite time period implementation, based on the existing structure of EU rules and regulations. The idea is to get hold of one another’s markets to continue on current terms throughout this period, and for it to be based on the existing structure of EU rules and regulations.

Also, the MHRA had ensured industry associations and other stakeholders that there would be no sudden changes to the UK regulatory framework. A comprehensive pragmatic approach would be established, while doing the negotiations. The BIA (BioIndustry Association), as well as the ABPI - the trade group representing the pharmaceutical industry in the UK - has responded to the MHRA's statement reiterating the importance of getting Brexit right. The officials announced that for patients and public, it is very difficult to get the guidelines right. All the associations and industry members will work towards bringing a common consensus among regulators, governments, and the Commission to mitigate risks. The complex issues around medicines and supply chain need to discuss at priority.