The MHRA recently delivered a project to consolidate and review UK medicines legislation.
The consolidation, delivered through the Human Medicines Regulations 2012, modernises medicines legislation. It replaces most of the Medicines Act 1968 and over 200 statutory instruments, which had been cluttering up the statute book and complicating the law. The exercise also took forward some policy changes to ensure the legislative framework remains fit for purpose.
Human Medicines Regulations 2012
The Human Medicines Regulations 2012 came into force on 14 August. Information on the Regulations is available here:
Human Medicines Regulations 2012
The Regulations also implement European Directive 2010/84/EU, which introduces new pharmacovigilance requirements. More information on this is available below:
New pharmacovigilance legislation, July 2012
Previous publications on the project
Public consultation MLX 375
Between October 2011 and January 2012 we held a 12 week public consultation on the draft consolidated regulations and proposals for policy change – MLX 375. Our response to this consultation is available below and the responses we received from interested parties are available on request:
Informal consultations
We have previously published a number of consultations to help us develop the draft regulations and proposals for MLX 375:
- In January 2009, we published a concept paper seeking views on possible areas where reform could be made .– a copy of this paper and a summary of responses can be found on the MHRA website - Concept paper on MHRA project to consolidate and review medicines legislation.
- In August 2010, we published an early, working draft of the consolidated regulations
(1869Kb) and a table of origins referencing the existing legislation (166Kb). This draft was published in order to provide an update on what the consolidation phase of the project had achieved to date (for the most part it did not include changes from the review phase) and to obtain informal views and comments from interested parties. - In October 2010 we published an informal consultation on patient group directions.
- Also in October 2010, we published an informal consultation on exemptions for sale, supply and administration of medicines.
- As part of the project, we are working to reflect the government’s aim of cutting the amount of existing regulation and reducing related paperwork and wider regulatory costs on business. To this end, we published in November 2010 a further informal consultation (75Kb) outlining opportunities that we have identified so far to reduce regulatory burdens through the project and seeking further suggestions from interested parties.
- In February 2011, we published an informal consultation on issues relating to the product licences of right (PLR) regime and homeopathy.
