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26 October 2011
The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a formal public consultation on the consolidation of UK medicines legislation.
The draft consolidated regulations will be presented to interested parties to test that they are complete, accurate, user-friendly and do not introduce unintended changes.
However, the Royal Pharmaceutical Society (RPS) has criticised the consultation for not including Section 64 of the Medicines Act. RPS President Martin Astbury said, “Section 64 of the Medicines Act, which criminalises single dispensing errors, causes pharmacists a great deal of anxiety and concern. “It’s therefore very disappointing to learn there is a newly identified legal barrier to progress on this matter.
“The RPS understands from the MHRA they intend to provide an alternative solution to the decriminalisation issue and we have been promised a further briefing on this in a few weeks time. We look forward to hearing what action is being proposed.
“The RPS will continue to press the Department of Health, Ministers and the MHRA on a swift resolution to decriminalisation. We will continue discussions at all levels throughout the autumn on the issue. Pharmacists will continue to practice under an unfair and unjust burden until the penalty for making a single error is finally abolished.
“The consultation does, of course, cover a wide variety of other issues and we will be examining the document in detail in order to provide a fuller response.”
More information on the consultation can be found at www.mhra.gov.uk/Publications/Consultations/Medicinesconsultations/MLXs/CON132054.