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August 2, 2010 - Authorisation of medicinal products in the first half of 2010
In the first six months of 2010 the Medicines Evaluation Board
(MEB) approved approximately 870 medicinal products and entered
them into the register. This is an increase of approximately 1%
with respect to 2009, which shows that the authorisation of
medicines has remained more or less constant. The MEB has refused
marketing authorisation for 1 medicinal product and suspended 5
medicinal products. On 30 June 2010, there were 13,382
authorised medicinal products resulting in a slight increase with
respect to 30 June 2009.
Active role in Europe for new medicinal products
A medicinal product can receive a national marketing
authorisation through a national procedure, a decentralised
procedure or a mutual recognition procedure. A medicinal product
can obtain a European marketing authorisation from the European
Commission through a centralised procedure. The MEB has a role in
all procedures as the national medicinal products authority.
In the first half of 2010, the MEB acted as (co-)assessor in 9
new applications that developed from the centralised procedure.
With that the MEB retains a leading position in Europe for this
In the first half of 2010 the MEB started 10 mutual recognition
procedures (MRPs) and 46 decentralised procedures (DCPs) in its
role as RMS (source MEB). The total number of MRP and DCP
procedures started in Europe increased in 2010 (source CMD). The
MEB’s share among the European Member States for both procedures
jointly is about 12%, illustrating that the MEB plays a very active
role in both MRP and DCP in Europe.
In the first six months of this year 13 reports of risk
information about medicinal products (Direct Healthcare
Professional Communications, DHPCs) were sent to doctors,
pharmacists or other medical professionals. The MEB coordinates
This Biannual Report is based on currently available data.
The MEB evaluates and monitors the efficacy, risks and quality
of human and veterinary medicinal products. The MEB also assesses
the safety of novel foods for human consumption.
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