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January 20, 2010 - Annual Notice: growth in the authorisation of medicinal products in 2009

The Medicines Evaluation Board has approved more than 1,600 new medicinal products for humans in 2009 and entered them into the register. This is an increase of 30% in comparison to 2008. This is particularly due to a larger number of medicinal products being entered through the decentralised procedure. The MEB has refused marketing authorisations for 23 medicines and suspended 65 medicinal products. The number of authorised medicinal products as of 31 December 2009 is more than 12,500, a slight increase in comparison to 1 January 2009.

Active role in Europe

A medicinal product can receive a national marketing authorisation from the MEB through a national procedure, a decentralised procedure and 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 2009 the MEB acted as (co)-assessor in 21 new applications in the centralised procedure. This procedure enables the MEB to maintain its leading position in Europe. In 2009 25 medicinal products authorised in the European register were based on new active ingredients. This applied to 17 medicinal products in 2008.

In 2009 the MEB started 63 Mutual Recognition Procedures (MRPs) and 210 Decentralised Procedures (DCPs) in its role as Reference Member State (RMS). There was a reduction in the total number of started MRPs and DCPs in Europe in 2009. The share of the MEB in the European member states for both procedures is 16% and the MEB once again played a very active role in Europe in MRPs as well as DCPs.

Pharmacovigilance

In 2009 17 Direct Healthcare Professional Communications (DHPC) were sent to physicians, pharmacists or other medical professionals. The MEB coordinates these letters that report urgent or important risks.

This Annual Notice is based on currently available data. The definitive data will be established later and will be specified in the 2009 Annual Report.

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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