Chemistry Reference
In-Depth Information
Structure of the MHRA
Executive Board
Chief Executive
Licensing
Vigilance & Risk
Management of
Medicines
Device
Technology &
Safety
Devices Clinical
Inspection and
Standards
Information
Management
Human
Resources
Operations
and Finance
Policy
Communications
Figure 10.1
The structure of the MHRA.
To achieve all of the tasks described above, the MHRA is organised into a
number of organisational divisions each responsible for one aspect of the
overall role. There are ten divisions in all, including
Inspection and
Standards Division
which ensures compliance with the standards that apply
to the manufacture and supply of medicines on the UK market;
Licensing
Division
, responsible for assessing and approving applications for marketing
authorisations for new medicinal products, new routes of administration or
new formulations for existing drugs; and
Vigilance and Risk Management
of Medicines Division
, whose objective is to protect public health by
promoting the safe use of marketed medicines. In addition to these key roles
there are a number of ancillary divisions responsible for matters such as
Communications, Policy, Finance and Human Resources. A complete
description of the internal organisation of the MHRA is outside the scope
of this topic but detailed information may be obtained from the MHRA
webpage at www.mhra.gov.uk.
European Licensing Procedures
Since the first European Directive on medicinal products was published in
1965, a lot of work has been done to harmonise the authorisation of medi-
cinal products across the European Union (EU). At the time of writing (early
2007) the most recent legislation is Directive 2001/83 implemented in
October 2005.
There are essentially two types of European licensing procedures:
•
the
Centralised Procedure (CP)
and the
•
Mutual Recognition (MRP)
or
Decentralised Procedure (DCP)
.
