Medicines and Healthcare products Regulatory Agency's response to
the shortage of Sinemet
We contacted the Medicines and Healthcare products
Regulatory Agency (MHRA) to ask them what they are doing about
the shortage of Parkinson's
drug Sinemet.
The MHRA is responsible for ensuring that medicines and
medical devices work and are acceptably safe.
They have provided us with the following statement.
Medicines and Healthcare products Regulatory Agency
statement
13 August 2010
"The MHRA is committed to ensuring that medicines available to
patients are safe, effective and of acceptable quality for use in
the UK.
"The MHRA have been working with the Marketing Authorisation
Holder (MSD) for Sinemet products, and have expedited the
assessment of variations to their licences where these had
implications on any supply shortage.
"A variation to add a new manufacturer of the drug substance was
submitted in relation to Sinemet Tablets in July 2009 and was
assessed within the usual 90 day time frame for this Type II
variation. This was a major 'complex' variation requiring
significant amounts of supporting data.
"To ensure the suitability of the new site questions were raised
following assessment of this variation and the points addressed by
the company through the provision of additional data. This
variation was approved in March 2010.
"Subsequent type II variations submitted in June and July,
including a variation to Sinemet CR Tablets, where expedited review
was considered justified in relation to continued supply have been
assessed and approved within 5 working days.
"We would recommend that you contact MSD UK for an update on when
normal supply is likely to resume, please find contact details
below."
- email
-
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