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The MHRA has today published a working draft of the consolidated UK medicines regulations.
As announced previously, the MHRA is undertaking a consolidation and review of medicines legislation. The aim of the project is to ensure that the legislative framework for medicines is comprehensive, comprehensible and fit for current purpose.
The project has two phases. The first phase (the 'consolidation') involves consolidating the existing legislation into one set of regulations while simplifying and clarifying the way it is drafted.
The second phase (the 'review') involves identifying areas where we might make substantive policy changes to existing provisions (where there is flexibility to do so under EU legislation) and further amending the draft regulations.
This draft is being published in order to provide an update on what the consolidation phase of the project has achieved so far (for the most part the draft does not include review changes, which will be taken forward at a later date) and to obtain informal views and comments .
This is not a formal consultation. The MHRA will, in consultation with interested parties, be carrying out a significant amount of further work on the review phase of the project. This will be followed by a formal consultation in early 2011 on the draft consolidated legislation and proposals for substantive change.
We would, however, be grateful for any high-level comments on whether the draft is clear and user-friendly and whether there are any issues that cause particular concern. Information on how to respond is included in the introductory text of the published document.
First draft of the consolidated medicines regulations 
