A concept paper has been launched as part of a project to consolidate and review medicines legislation. The agency says that, although the 1968 Medicines Act has stood the test of time, it has become complex and fragmented. In addition, some provisions may no longer be fit for purpose or may contradict EU regulations.
The paper proposes areas for reform and comment is sought on these, along with suggestions for others. ‘Please be radical,’ the MHRA says
The suggested topics for review include: clinical trials, patient information, advertising, sale and supply and pharmacovigilence. The concept paper is available from the MHRA website.
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