UK to introduce some European medicines law early
Plans to implement three aspects of new
European medicines legislation in the UK before they become mandatory are to go ahead (PJ,
7 August, p175).
From 1 January 2005, companies that achieve the reclassification of medicines
from POM to P or from P to GSL on the basis of significant test or trial
results will get a year’s data protection for their results. This
means that competitor companies will have to carry out their own tests
if they want to switch equivalent products.
Also from 1 January 2005, companies will be required to tell the Medicines
and Healthcare products Regulatory Agency about any new information that
impacts on the risk or benefit of a medicine.
From 1 July 2005, patient information leaflets for new products will
have to reflect the results of tests on user groups. This change was
originally proposed for April 2005.
European legislation requires these, and a range of other changes, to
be implemented by the end of October 2005. |
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