Regulatory Focus™ > News Articles > MHRA Releases New Guidance for Impending Changes to Labeling Regulations

MHRA Releases New Guidance for Impending Changes to Labeling Regulations

Posted 01 June 2012 | By Alexander Gaffney, RAC 

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) is announcing the launch of new guidance to assist sponsors looking to comply with the terms of new regulations set to change how sponsors can label their products.

Under the terms of the Better Regulation of Medicines Initiative (BROMI), MHRA is taking a more targeted approach to how it regulates medicines by re-focusing its resources on higher-risk activities.

One of the numerous changes to be implemented under the re-organization is a reformed notification scheme for registering amendments to labeling and patient information leaflets, which is scheduled to come into effect in July 2012. To help sponsors prepare for the new regulations, MHRA said it is releasing guidance to industry two months in advance of the changes to allow them to understand the regulations.

The guidance documents include information on the best practices for labeling and packaging medicines, additional warning statements to be included on the packaging or package inserts of certain medicines, how to submit packaging or patient leaflets to MHRA for assessment, how to make changes to leaflets or package inserts and best practices for patient information leaflets.

MHRA is also announcing a series of three workshops to help train industry on the changes. The workshops will occur in June and will be hosted by the British Generics Manufacturers' Association.


Read more:

MHRA - New BROMI Notification Scheme guidance


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